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      • id1111
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      • abstract_of_study<div>\n Title:<span style=\"white-space:pre\"> </span>Safety and Efficacy of L9LS, a Human Monoclonal Antibody Against Plasmodium falciparum, in an Age De-Escalation, Dose-Escalation Trial and a Randomized, Placebo-Controlled, Double-Blind Trial of Children in Western Kenya</div>\n<div>\n Study Description:<span style=\"white-space:pre\"> </span>A two-part, phase 2 trial evaluating the safety and tolerability of one-time subcutaneous (SC) administration of monoclonal antibody (MAb) L9LS in healthy Kenyan children aged 5 months to 10 years, as well as the protective efficacy of one or two doses of L9LS against naturally occurring Plasmodium falciparum (Pf) infection among Kenyan children aged 5 to 59 months at enrollment, in a setting of perennial high transmission. The primary study hypotheses are that L9LS will be safe and will produce protection against malaria infection. Before study agent administration, all subjects will be given dihydro-artemisinin-piperaquine (DP) to clear any preexisting Pf blood-stage infection.</div>\n<div>\n  </div>\n<div>\n Part 1: Age de-escalation and dose-escalation study</div>\n<div>\n In a stepwise fashion, children aged 5-10 years will receive 5 mg/kg of L9LS or placebo and be followed for 3 months to assess tolerability and safety. If acceptable tolerability and safety profiles are met at 1-week post-injection, we will administer the 5-mg/kg dose of L9LS or placebo to children aged 5-59 months while enrolling another cohort of children aged 5-10 years at a dose of 10 mg/kg of L9LS or placebo. If after 1 week, the 10-mg/kg dose is found to be safe in children aged 5-10 years and the 5-mg/kg dose is found to be safe in children aged 5-59 months, we will then administer a 20 mg/kg dose of L9LS or placebo to children aged 5-10 years and a 10-mg/kg dose of L9LS or placebo to children aged 5-59 months. Finally, if these doses are found safe after 1 week, we will administer a 20-mg/kg dose of L9LS or placebo to children aged 5-59 months. Should tolerability and safety of all doses be acceptable in children aged 5-59 months, we will move to part 2 of the trial. Dosing in part 1 of the study will be weight-based and all doses will be administered SC in a double-blinded fashion. We will enroll 12 participants in each age-dose group in a 3:1 ratio of L9LS to placebo, and all participants will be followed for a total of 3 months.</div>\n<div>\n  </div>\n<div>\n Part 2: Efficacy study</div>\n<div>\n Children 5-59 months of age will be randomized to receive a 10-19 mg/kg dose of L9LS or placebo by SC administration. There will be two L9LS cohorts, one 5-17 months of age and another 18-59 months of age, which will constitute one L9LS arm. A placebo arm will be composed of children 5–59 months of age. They will be followed over 12 months with monthly blood smear microscopy and polymerase chain reaction (PCR) and twice-monthly symptomatology and care-seeking behavior questionnaires. Dosing will be based on three weight bands; all doses will be administered SC with fixed doses of 75 mg L9LS or 150 mg L9LS or a combination of the two (225 mg L9LS), resulting in a range of 10-19 mg/kg in a double-blinded fashion. Blood will be drawn to assess antibody titers at baseline, and at three additional time points over 12 months to establish pharmacokinetics (PK). Participants in the L9LS arm will be randomized 1:1 at baseline to receive either a second L9LS injection or a placebo injection to evaluate the additional efficacy of a second dose administered 6 months after the first dose. (Those in the placebo arm will receive a second injection of placebo.) Participants will be followed for an additional 6 months after the second injection with monthly blood smear microscopy and PCR, and a blood draw at month 11 to assess L9LS PK.</div>\n<div>\n Objectives:</div>\n<div>\n Primary Objectives:</div>\n<div>\n Part 1:</div>\n<div>\n 1.<span style=\"white-space:pre\"> </span>Safety: To evaluate the safety and tolerability of L9LS administered at doses of 5 mg/kg, 10 mg/kg, and 20 mg/kg by SC administration to healthy Kenyan children.</div>\n<div>\n Part 2:</div>\n<div>\n 2.<span style=\"white-space:pre\"> </span>Safety: To evaluate the safety and tolerability of L9LS administered at doses of 10-19 mg/kg by SC administration to healthy Kenyan children.</div>\n<div>\n 3.<span style=\"white-space:pre\"> </span>Efficacy: To assess the efficacy of two doses of L9LS at a concentration of 10-19 mg/kg, administered SC to participants aged 5-59 months of age against first/only Pf malaria infection diagnosed by blood smear microscopy (irrespective of fever) over 12 months compared to placebo.</div>\n<div>\n  </div>\n<div>\n Secondary Objectives:</div>\n<div>\n 1.<span style=\"white-space:pre\"> </span>To assess the efficacy of one dose of L9LS at 10-19 mg/kg against first/only Pf malaria infection diagnosed by blood smear microscopy over 3 and 6 months compared to placebo.</div>\n<div>\n 2.<span style=\"white-space:pre\"> </span>To assess the efficacy of one dose of L9LS at 10-19 mg/kg against first/only Pf malaria infection diagnosed by blood smear microscopy over 12 months compared to placebo.</div>\n<div>\n 3.<span style=\"white-space:pre\"> </span>To evaluate the efficacy of L9LS at 10-19 mg/kg against first/only Pf malaria infection as detected by PCR over 6 and 12 months compared to placebo.</div>\n<div>\n 4.<span style=\"white-space:pre\"> </span>To assess protection of L9LS at 10-19 mg/kg against clinical malaria (first/only and all episodes) at 6 and 12 months compared to a placebo.</div>\n<div>\n 5.<span style=\"white-space:pre\"> </span>To assess the primary objective and secondary objectives 1-4 among children 5-17 months of age.</div>\n<div>\n 6.<span style=\"white-space:pre\"> </span>To assess the primary objective and secondary objectives 1-4 among children 18-59 months of age.</div>\n<div>\n 7.<span style=\"white-space:pre\"> </span>To evaluate the PK of L9LS throughout the study at weight-based dose levels of 5 mg/kg, 10 mg/kg, and 20 mg/kg (part 1) and fixed doses of 10-19 mg/kg (part 2) in healthy Kenyan children, and</div>\n<div>\n a.<span style=\"white-space:pre\"> </span>To correlate L9LS serum concentration with Pf infection risk.</div>\n<div>\n b.<span style=\"white-space:pre\"> </span>To correlate L9LS serum concentration with clinical malaria risk.</div>\n<div>\n Endpoints:<span style=\"white-space:pre\"> </span>Primary Endpoints:</div>\n<div>\n 1.<span style=\"white-space:pre\"> </span>Part 1 and Part 2: Incidence and severity of local and systemic adverse events (AEs) occurring within 7 days after the administration of L9LS, and incidence of serious adverse events (SAEs) throughout the study period.</div>\n<div>\n 2.<span style=\"white-space:pre\"> </span>Part 2: Pf blood-stage infection as detected by microscopic examination of thick blood smear for 52 weeks after administration of L9LS or placebo.</div>\n<div>\n  </div>\n<div>\n Secondary Endpoints:</div>\n<div>\n Data from one or both parts of this study will be used to assess the following endpoints:</div>\n<div>\n 1.<span style=\"white-space:pre\"> </span>Pf blood-stage infection as detected by microscopic examination of thick blood smear for 24 weeks after administration of L9LS or placebo.</div>\n<div>\n 2.<span style=\"white-space:pre\"> </span>Pf blood-stage infection as detected by RT-PCR for 24 and 52 weeks after administration of L9LS or placebo.</div>\n<div>\n 3.<span style=\"white-space:pre\"> </span>Incidence of clinical malaria (definition 1, see section 2.2.2.3) for 24 and 52 weeks after administration of L9LS or placebo.</div>\n<div>\n 4.<span style=\"white-space:pre\"> </span>Incidence of clinical malaria (definition 2, see section 2.2.2.3) for 24 and 52 weeks after administration of L9LS or placebo.</div>\n<div>\n 5.<span style=\"white-space:pre\"> </span>Measurement of L9LS in sera of recipients (parts 1 and 2).</div>\n<div>\n 6.<span style=\"white-space:pre\"> </span>PK analysis of L9LS and the association of L9LS concentration with Pf infection risk.</div>\n<div>\n 7.<span style=\"white-space:pre\"> </span>PK analysis of L9LS and the association of L9LS concentration with clinical malaria risk.</div>\n<div>\n  </div>\n<div>\n Study Population:<span style=\"white-space:pre\"> </span>We will enroll a total of 396 healthy Kenyan children, including 72 ages 5 months to 10 years residing in western Kenya for part 1 and 324 ages 5-59 months for part 2.</div>\n<div>\n  </div>\n
      • study_title<p>\n Safety and Efficacy of L9LS, a Human Monoclonal Antibody Against <em>Plasmodium falciparum</em>, in an Age De-Escalation, Dose-Escalation Trial and a Randomized, Placebo-Controlled, Double-Blind Trial of Children in Western Kenya</p>\n
      • laymans_summary<div>\n Malaria is a disease that affects many people in the world, more so in sub-Saharan Africa. It is caused by parasites carried by mosquitoes. When the mosquitoes bite people, the parasites can pass into their blood and cause illness, which if not treated in a timely manner or sufficiently, can cause severe illness or even death. In effect, despite there being medicines to cure malaria, it is still responsible for a huge number of admissions and deaths, especially in Africa. This informs the need to come up with new ways to reduce the impact of malaria, for example, through preventing people from getting malaria in the first place. </div>\n<div>\n  </div>\n<div>\n This is a research study to test an experimental drug, called L9LS, for malaria. L9LS is a type of drug called a monoclonal antibody. Antibodies are natural products made by the human body to fight infection by blocking germs such as bacteria and parasites. Monoclonal means that all the antibodies in the drug are exactly the same. The study drug stays in the blood for several months and blocks the parasite that causes malaria. We hope that, if enough of the drug is in the blood, it will prevent people from getting malaria.</div>\n<div>\n  </div>\n<div>\n The study aims to find out how safe the drug is and whether it prevents malaria and if so, to what extent. This study will be conducted in two parts. In the first part, involving 72 participants, the study will investigate how safe and well tolerated three different increasing doses of the study drug are by administering each dose to older children first (5-10 years of age) then to younger children (5-59 months of age) 1 week after each different dose, if it is well tolerated and safe in the older age group. The study will proceed to part 2 if the doses are safe and well tolerated in the younger age group, as determined by a data safety and monitoring board. The second part of the study will investigate whether the drug prevents malaria, and if so, to what extent. It will enroll an equal number of children aged between 5-17 months and those aged 18-59 months, totalling to about 324 participants. Each age category will further have 3 groups of children assigned by chance to each group. The first group will receive two doses of the study drug 6 months apart, the 2nd group will receive the study drug then placebo (saltwater/an inactive substance similar to study drug) 6 months after, and the 3rd group will receive two doses of the placebo 6 months part. </div>\n<div>\n Other objectives which will be explored by the study include comparing the study drug level with the possibility of getting a malaria infection or detecting malaria parasites in the blood.</div>\n<div>\n  </div>\n<div>\n The study will take place at Siaya County Referral Hospital and Kogelo Dispensary, both in Siaya County, western Kenya. The study duration will be approximately 24 months, with a participant in Part 1 of the study taking 4-5 months and a participant in Part 2 of the study taking 13-14 months.</div>\n<div>\n  </div>\n<div>\n The study procedures in Part 1 will entail assessing participant eligibility, getting consent and enrollment into the study. On enrollment, participants will receive a standard dose of antimalarial  followed by the study drug or placebo after 2 weeks. They will then have another 10 study visits within a 3 months period to monitor various safety measures. The study procedures in Part 2 will entail assessing participant eligibility, getting consent and enrollment into the study. On enrollment, participants will receive a standard dose of antimalarial followed by the study drug or placebo after 2 weeks. They will then have a study visit every month up to end of month 6 when they will receive the 2nd dose of either the study drug or placebo. Other follow up visits will be conducted monthly until end of 12 months from the date of initial study drug or placebo dose. These follow-up visits will assess both safety and efficacy measures.</div>\n<div>\n  </div>\n<div>\n The study will provide information on the safety and usefulness of L9LS as a therapy used in </div>\n<div>\n the prevention of malaria.</div>\n<div>\n  </div>\n
      • short_titleAnti-malaria MAb in Kenyan chi
      • protocol_noECCT/22/05/03
      • version_no2.0
      • date_of_protocol28-03-2022
      • study_drugL9LS
      • disease_conditionMalaria
      • product_type_biologicals1
      • product_type_proteins0
      • product_type_immunologicals1
      • product_type_vaccines0
      • product_type_hormones0
      • product_type_toxoid0
      • product_type_chemical0
      • product_type_medical_device0
      • product_type_chemical_nameL9LS
      • product_type_medical_device_name
      • comparatorNo
      • comparator_nameInactive Normal Saline
      • comparator_registeredYes
      • comparator_countriesGlobal
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addresstonysangke@gmail.com
      • applicant_covering_letter1
      • applicant_protocol1
      • applicant_patient_information1
      • applicant_investigators_brochure1
      • applicant_investigators_cv1
      • applicant_signed_declaration1
      • applicant_financial_declaration1
      • applicant_gmp_certificate1
      • applicant_indemnity_cover1
      • applicant_opinion_letter1
      • applicant_approval_letter1
      • applicant_statement1
      • applicant_participating_countries(null)
      • applicant_addendum0
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      • applicant_gcp_training1
      • applicant_dsmb_charter1
      • applicant_detailed_budget1
      • applicant_indemnity_pi1
      • applicant_practice_license1
      • applicant_registration_ctr(null)
      • applicant_pan_african1
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      • statistical_analysis_plan1
      • applicant_contractual_agreement1
      • declaration_applicantTony Sang
      • declaration_date126-05-2022
      • declaration_principal_investigatorTitus Kwambaai
      • declaration_date226-05-2022
      • placebo_presentYes
      • study_objectives<p>\n <u>Primary Objectives</u>:</p>\n<p>\n Part 1:</p>\n<ol>\n <li>\n Safety: To evaluate the safety and tolerability of L9LS administered at doses of 5 mg/kg, 10 mg/kg, and 20 mg/kg by SC administration to healthy Kenyan children.</li>\n</ol>\n<p>\n Part 2:</p>\n<ol>\n <li value=\"2\">\n Safety: To evaluate the safety and tolerability of L9LS administered at doses of 10-19 mg/kg by SC administration to healthy Kenyan children.</li>\n <li value=\"3\">\n Efficacy: To assess the efficacy of two doses of L9LS at a concentration of 10-19 mg/kg, administered SC to participants aged 5-59 months of age against first/only Pf malaria infection diagnosed by blood smear microscopy (irrespective of fever) over 12 months compared to placebo.</li>\n</ol>\n<p style=\"margin-left:18.0pt;\">\n 1.      To assess the efficacy of one dose of L9LS at 10-19 mg/kg against first/only Pf malaria infection diagnosed by blood smear microscopy over 3 and 6 months compared to placebo.</p>\n<p style=\"margin-left:18.0pt;\">\n 2.      To assess the efficacy of one dose of L9LS at 10-19 mg/kg against first/only Pf malaria infection diagnosed by blood smear microscopy over 12 months compared to placebo.</p>\n<p style=\"margin-left:18.0pt;\">\n 3.      To evaluate the efficacy of L9LS at 10-19 mg/kg against first/only Pf malaria infection as detected by PCR over 6 and 12 months compared to placebo.</p>\n<p style=\"margin-left:18.0pt;\">\n 4.      To assess protection of L9LS at 10-19 mg/kg against clinical malaria (first/only and all episodes) at 6 and 12 months compared to a placebo.</p>\n<p style=\"margin-left:18.0pt;\">\n 5.      To assess the primary objective and secondary objectives 1-4 among children 5-17 months of age.</p>\n<p style=\"margin-left:18.0pt;\">\n 6.      To assess the primary objective and secondary objectives 1-4 among children 18-59 months of age.</p>\n<p>\n To evaluate the PK of L9LS throughout the study at weight-based dose levels of 5 mg/kg, 10 mg/kg, and 20 mg/kg (part 1) and fixed doses of 10-19 mg/kg (part 2) </p>\n<p style=\"margin-left:18.0pt;\">\n       in healthy Kenyan children, and</p>\n<p style=\"margin-left:54.0pt;\">\n a.       To correlate L9LS serum concentration with Pf infection risk.</p>\n<p>\n To correlate L9LS serum concentration with clinical malaria risk.</p>\n
      • principal_inclusion_criteria<p style=\"margin-left:36.0pt;\">\n 1.      Healthy children aged 5 months to 10 years (Part 1) or 5-59 months (Part 2).</p>\n<p style=\"margin-left:36.0pt;\">\n 2.      Weight ≥5 kg and weight ≤30 kg (Part 1) or weight ≥5 kg and ≤22.5 kg (Part 2)</p>\n<p style=\"margin-left:36.0pt;\">\n 3.      Hemoglobin level ≥8 g/dL.</p>\n<p style=\"margin-left:36.0pt;\">\n 4.      Height and weight Z-scores >-2.</p>\n<p style=\"margin-left:36.0pt;\">\n 5.      Living within Alego-Usonga sub-county.</p>\n<p style=\"margin-left:36.0pt;\">\n 6.      Able to participate for the duration of the trial.</p>\n<p>\n Parent and/or guardian of participant able to provide informed consent</p>\n
      • principal_exclusion_criteria<ol>\n <li>\n Known sickle cell disease.</li>\n <li>\n Taking long-term cotrimoxazole.</li>\n <li>\n Enrolled in another clinical trial.</li>\n <li>\n Received any doses of any malaria vaccine.</li>\n <li>\n Participation in part 1 of this study (for individuals being screened for enrollment into part 2)</li>\n <li>\n Age < 12 months at the time the RTS,S/AS01 vaccine is anticipated to become available in the whole of Siaya County</li>\n <li>\n Current significant medical condition (cardiac, hepatic, renal, or hematological) or evidence of any other serious underlying medical condition identified by medical history, physical examination, or laboratory examination.</li>\n <li>\n History of any other illness or condition which, in the investigator's judgment, may substantially increase the risk associated with the subject’s participation in the protocol or compromise the scientific objectives.</li>\n <li>\n Any history of menses.</li>\n <li>\n Behavioral, cognitive, or psychiatric disease that in the opinion of the investigator affects the ability of the subject to understand and comply with the study protocol.</li>\n <li>\n Parental/guardian study comprehension examination score of <80% correct or per investigator discretion.</li>\n <li>\n Hemoglobin, white blood cell, absolute neutrophil, or platelet count outside the local laboratory-defined limits of normal. (Subjects may be included at the investigator’s discretion for “not clinically significant” values.)</li>\n <li>\n Alanine transaminase (ALT) or creatinine (Cr) level above the local laboratory-defined upper limit of normal. (Subjects may be included at the investigator’s discretion for “not clinically significant” values.)</li>\n <li>\n Infected with HIV.</li>\n <li>\n Known or documented sickle cell disease by history. (Note: Known sickle cell trait is NOT exclusionary.)</li>\n <li>\n Evidence of clinically significant neurologic, cardiac, pulmonary, hepatic, endocrine, rheumatologic, autoimmune, hematological, oncologic, or renal disease by history, physical examination, and/or laboratory studies.</li>\n <li>\n Receipt of any investigational product within the past 30 days.</li>\n <li>\n Participation or planned participation in an interventional trial with an investigational product until the last required protocol visit. (Note: Past, current, or planned participation in observational studies is NOT exclusionary.)</li>\n <li>\n History of a severe allergic reaction or anaphylaxis.</li>\n <li>\n Severe asthma (defined as asthma that is unstable or required emergency care, urgent care, hospitalization, or intubation during the past 2 years, or that has required the use of oral or parenteral corticosteroids at any time during the past 2 years).</li>\n <li>\n Pre-existing autoimmune or antibody-mediated diseases including but not limited to: systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis, Sjogren’s syndrome, or autoimmune thrombocytopenia.</li>\n <li>\n Known immunodeficiency syndrome.</li>\n <li>\n Known asplenia or functional asplenia.</li>\n <li>\n Use of chronic (≥14 days) oral or IV corticosteroids (excluding topical or nasal) at immunosuppressive doses (i.e., prednisone >10 mg/day) or immunosuppressive drugs within 30 days of day 0.</li>\n <li>\n Receipt of a live vaccine within the past 4 weeks or a killed vaccine within the past 2 weeks prior to study agent administration.</li>\n <li>\n Receipt of immunoglobulins and/or blood products within the past 6 months.</li>\n <li>\n Known allergies or contraindication to dihydroartemisinin-piperaquine.</li>\n <li>\n Clinical signs of malnutrition.</li>\n <li>\n Other condition(s) that, in the opinion of the investigator, would jeopardize the safety or rights of a subject participating in the trial, interfere with the evaluation of the study objectives, or render the subject unable to comply with the protocol.</li>\n <li>\n Use or known need at the time of enrolment (DP administration) for concomitant prohibited medication.  Patients taking any of the following drugs:\n <ol style=\"list-style-type:lower-alpha;\">\n <li>\n Antimicrobial agents of the following classes (systemic use only):\n <ol style=\"list-style-type:lower-roman;\">\n <li>\n Macrolides (e.g. erythromycin, clarithromycin, azithromycin, roxithromycin)</li>\n <li>\n Fluoroquinolones (e.g., levofloxacin, moxifloxacin, sparfloxacin)</li>\n <li>\n Pentamidine</li>\n </ol>\n </li>\n <li>\n Antiarrhythmic agents (e.g. amiodarone, sotalol)</li>\n <li>\n Antihistamines (e.g. promethazine)</li>\n <li>\n Antifungals (systemic): ketoconazole, fluconazole, itraconazole</li>\n <li>\n Antiretrovirals: Saquinavir</li>\n <li>\n Diuretics (e.g. hydrochlorothiazide, furosemide)</li>\n <li>\n Antipsychotics (neuroleptics): haloperidol, thioridazine</li>\n <li>\n Antidepressants: imipramin, citalopram, escitalopram</li>\n <li>\n Antiemetics: domperidone, chlorpromazine, ondansetron </li>\n </ol>\n </li>\n <li>\n Increased risk of salivary gland hypofunction (dryness of the mouth, swelling under the tongue and/or below the ear, halitosis)</li>\n</ol>\n<p>\n  </p>\n
      • primary_end_points<ol>\n <li>\n Parts 1 & 2: Incidence and severity of local and systemic AEs occurring within 7 days after the administration of L9LS, and incidence of SAEs throughout the study period.</li>\n <li>\n Part 2: Pf blood-stage infection as detected by microscopic examination of thick blood smear for 52 weeks after administration of L9LS or placebo.</li>\n</ol>\n<p>\n  </p>\n
      • scope_diagnosis0
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      • scope_safety1
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      • scope_pharmacodynamic0
      • scope_bioequivalence0
      • scope_dose_response0
      • scope_pharmacogenetic0
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic0
      • scope_others0
      • scope_others_specify
      • trial_human_pharmacology0
      • trial_administration_humans0
      • trial_bioequivalence_study0
      • trial_other0
      • trial_other_specify
      • trial_therapeutic_exploratory1
      • trial_therapeutic_confirmatory0
      • trial_therapeutic_use0
      • design_controlledYes
      • site_capacity(null)
      • staff_numbers<p>\n <strong>Co-Principal Investigators:</strong></p>\n<p>\n Titus Kwambai, MD, PhD, Epidemiologist Centers for Disease Control and Prevention Kenya Malaria Program Phone: +254 722207281 Email: qbb5<a href=\"mailto:LSteinhardt@cdc.gov\">@cdc.gov</a></p>\n<p>\n Laura Steinhardt, PhD, MPH Malaria Branch, US CDC 1600 Clifton Rd., Atlanta, GA 30329 Phone: +1-404-718-4794 Email: <a href=\"mailto:LSteinhardt@cdc.gov\">LSteinhardt@cdc.gov</a></p>\n<p>\n Peter D. Crompton, MD, MPH, Chief, Malaria Infection Biology and Immunity Section Laboratory of Immunogenetics (LIG), National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), Phone: 240-383-7640 Email: <a href=\"mailto:pcrompton@niaid.nih.gov\">pcrompton@niaid.nih.gov</a></p>\n<p>\n <strong>Co-Investigators</strong></p>\n<p>\n Kevin K’Orimba, MD, MPH,KEMRI Center for Global Health Research (CGHR) P.O. Box: 1578 - 40100, Kisumu, Kenya , Phone: +254722324496, E-mail: <a href=\"mailto:korimbakevin@gmail.com\">korimbakevin@gmail.com</a>, Role(s): A, B, C, D, E, F, G</p>\n<p>\n Martina Oneko, MD ,KEMRI CGHR,P.O. Box: 1578 - 40100, Kisumu, Kenya,Phone: +254-717-747-279, Email: <a href=\"mailto:tinaoneko@gmail.com\">tinaoneko@gmail.com</a>,Role(s): A, B, C, D, E, F, G</p>\n<p>\n Simon Kariuki, PhD,KEMRI CGHR,Phone: +254 725 389 246, Email: <a href=\"mailto:skariuki1578@gmail.com\">skariuki1578@gmail.com</a>,Role(s): A, B, E, F, G</p>\n<p>\n Tony Sang, BPharm,KEMRI CGHR,P.O. Box: 1578 - 40100, Kisumu, Kenya<br />\n Phone: +254 721 246 875,Email: <a href=\"mailto:tonysangke@gmail.com\">tonysangke@gmail.com</a></p>\n<p>\n Kephas Otieno, MSc,KEMRI CGHR, P.O. Box: 1578 - 40100, Kisumu, Kenya<br />\n Phone: +254 721 405 643,Email: kotieno72@yahoo.com,Role(s):</p>\n<p>\n <strong>Trial Pharmacist</strong></p>\n<p>\n Tony Sang, BPharm,KEMRI CGHR,P.O. Box: 1578 - 40100, Kisumu, Kenya</p>\n<p>\n Phone: +254 721 246 875,Email: <a href=\"mailto:tonysangke@gmail.com\">tonysangke@gmail.com</a></p>\n<p>\n Lilian Otieno, DipPharm, BA,KEMRI Center for Global Health Research (CGHR) P.O. Box: 1578 - 40100, Kisumu, Kenya , Phone: +254723934572, Email: <a href=\"mailto:lotieno@kemricdc.org\">lotieno@kemricdc.org</a>, <a href=\"mailto:otililly@yahoo.com\" style=\"font-size: 9pt; font-family: Arial, sans-serif;\">otililly@yahoo.com</a></p>\n<p>\n <strong>Regulatory Officer</strong></p>\n<p>\n Lilian Otieno, DipPharm, BA,KEMRI Center for Global Health Research (CGHR) P.O. Box: 1578 - 40100, Kisumu, Kenya , Phone: +254723934572, Email: <a href=\"mailto:lotieno@kemricdc.org\">lotieno@kemricdc.org</a>, <a href=\"mailto:otililly@yahoo.com\" style=\"font-family: Arial, sans-serif; font-size: 9pt;\">otililly@yahoo.com</a></p>\n<p>\n <strong>Study Coordinator</strong></p>\n<p>\n Reuben Yego, BSPH,KEMRI Center for Global Health Research (CGHR) P.O. Box: 1578 - 40100, Kisumu, Kenya , Phone: +254723934572, E-mail: <a href=\"mailto:lotieno@kemricdc.org\">lotieno@kemricdc.org</a>, <a href=\"mailto:otililly@yahoo.com\" style=\"font-size: 9pt; font-family: Arial, sans-serif;\">otililly@yahoo.com</a></p>\n<p>\n  </p>\n
      • other_details_explanation<p>\n N/A</p>\n
      • other_details_regulatory_notapproved<p>\n FDA-Submission done, awaiting Approval</p>\n
      • other_details_regulatory_approved<p align=\"left\" style=\"margin-left:144pt;\">\n Bill and Melinda Gates Foundation-DAC BMGF-DAC</p>\n<p align=\"left\" style=\"margin-left:144pt;\">\n National Institute of Allergy and Infectious Diseases (NIAID)</p>\n<p align=\"left\" style=\"margin-left:144pt;\">\n LSTM-Research Ethics Committee (LSTM-REC)</p>\n
      • other_details_regulatory_rejected<p>\n NONE</p>\n
      • other_details_regulatory_halted<p>\n N/A</p>\n
      • estimated_duration2 years
      • design_controlled_randomisedYes
      • design_controlled_openNo
      • design_controlled_single_blindNo
      • design_controlled_double_blindYes
      • design_controlled_parallel_groupNo
      • design_controlled_cross_overNo
      • design_controlled_otherNo
      • design_controlled_specify
      • design_controlled_comparatorsterile isotonic (0.9%) n
      • design_controlled_other_medicinalNo
      • design_controlled_placeboNo
      • design_controlled_medicinal_otherNo
      • design_controlled_medicinal_specify
      • single_site_member_stateNo
      • location_of_area
      • single_site_physical_address
      • single_site_contact_person
      • single_site_telephone
      • multiple_sites_member_stateYes
      • multiple_countriesNo
      • multiple_member_states
      • number_of_sites2
      • multi_country_list
      • data_monitoring_committeeYes
      • total_enrolment_per_site72 for part 1 and 324 for part 2.
      • total_participants_worldwide396
      • population_less_than_18_yearsYes
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerYes
      • population_childrenYes
      • population_adolescentNo
      • population_above_18No
      • population_adultNo
      • population_elderlyNo
      • gender_female1
      • gender_male1
      • subjects_healthyYes
      • subjects_patientsNo
      • subjects_vulnerable_populationsYes
      • subjects_women_child_bearingNo
      • subjects_women_using_contraceptionNo
      • subjects_pregnant_womenNo
      • subjects_nursing_womenNo
      • subjects_emergency_situationNo
      • subjects_incapable_consentYes
      • subjects_specifyChildren aged 5 months to 10 years
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameTitus
      • investigator1_middle_name
      • investigator1_family_nameKwambai
      • investigator1_qualificationMD, PhD
      • investigator1_professional_addressCenters for Disease Control and Prevention Kenya Malaria Program
      • investigator1_telephone+254 722207281
      • investigator1_emailqbb5@cdc.gov
      • organisations_transferred_Yes
      • number_participants396
      • notification
      • approval_date08-08-2022
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted26-05-2022
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reasonThe Reviewer queries have been answered adequately
      • final_report(null)
      • implication_results(null)
      • quantity_imported(null)
      • quantity_dispensed(null)
      • quantity_destroyed(null)
      • quantity_exported(null)
      • balance_site(null)
      • final_date(null)
      • modified2024-08-20 11:32:31
      • created2022-01-26 15:22:56
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id784
        • application_id1111
        • given_nameTitus
        • middle_name
        • family_nameKwambai
        • qualificationMD, PhD
        • professional_addressCenters for Disease Control and Prevention Kenya Malaria Program
        • telephone+254 722207281
        • emailqbb5@cdc.gov
        • created2022-01-26 15:26:17
        • modified2022-05-26 23:33:58
      • 1(array)
        • id785
        • application_id1111
        • given_nameLaura
        • middle_name
        • family_nameSteinhardt
        • qualificationPhD, MPH, Epidemiologist
        • professional_addressMalaria Branch Center for Global Health Centers for Disease Control and Prevention
        • telephone+14047184794
        • emailLSteinhardt@cdc.gov
        • created2022-01-26 15:53:08
        • modified2022-05-26 23:33:58
      • 2(array)
        • id786
        • application_id1111
        • given_nameRobert
        • middle_nameA
        • family_nameSeder
        • qualificationMD
        • professional_addressVaccine Research Center (VRC), National Institute of Allergy and Infectious Diseases (NIAID), NIH
        • telephone301-594-8483
        • emailrseder@mail.nih.gov
        • created2022-01-26 15:54:33
        • modified2022-05-26 23:33:58
    • SiteDetail(array)
      • 0(array)
        • id1228
        • application_id1111
        • county_id41
        • site_nameSiaya County Referral Hospital
        • physical_addressOff Hospital Road, Siaya Township
        • contact_details0722207281
        • contact_personDr. Titus Kwambai
        • site_capacity(null)
        • misc(null)
        • created2022-01-26 15:26:17
        • modified2022-05-26 23:33:58
        • County(array)
          • id41
          • county_nameSiaya
          • created2012-06-15 10:26:56
          • modified2012-06-15 10:26:56
      • 1(array)
        • id1229
        • application_id1111
        • county_id41
        • site_nameKogelo Health Center
        • physical_addressKogelo Nyang\'oma
        • contact_details0722207281
        • contact_personDr. Titus Kwambai
        • site_capacity(null)
        • misc(null)
        • created2022-01-26 16:11:18
        • modified2022-05-26 23:33:58
        • County(array)
          • id41
          • county_nameSiaya
          • created2012-06-15 10:26:56
          • modified2012-06-15 10:26:56
    • Sponsor(array)
      • 0(array)
        • id573
        • application_id1111
        • sponsorOffice of Clinical Research Policy and Regulatory Operations (OCRPRO), Division of Clinical Research (DCR), NIAID
        • sponsor_typeResearch Institution
        • contact_personRobert A. Seder, MD
        • addressVaccine Research Center (VRC), National Institute of Allergy and Infectious Diseases (NIAID), NIH
        • telephone_number+1-301-594-8483
        • fax_number
        • cell_number+1-301-594-8483
        • email_addressrseder@mail.nih.gov
        • created2022-01-26 15:26:17
        • modified2022-05-26 23:33:58
  • 1(array)
    • Application(array)
      • id1108
      • user_id360
      • trial_status_id6
      • abstract_of_study<p>\n SARS-CoV-2, the cause of the coronavirus disease 2019 (COVID-19) pandemic, has evolved into new strains that are also referred to as ‘variants.’ A rapidly spreading variant called B.1.351, first identified in South Africa has now spread to Kenya. This variant is considered a ‘variant of concern’ because it is more transmissible than the original strain and because some vaccines appear to have reduced protection against this strain of SARS-CoV-2. In vitro, the B.1.351 variant’s mutations reduce efficiency of neutralizing antibodies induced by the Moderna mRNA (original Wuhan strain) vaccine. It is unknown whether this in vitro finding also reduces the clinical efficacy of the vaccine.</p>\n<p>\n The B.1.617 (Delta) variant is already the dominant strain in the UK and has spread rapidly to other countries in Eastern and Southern Africa including Kenya. The Moderna mRNA vaccine has shown that the serum of vaccinated participants one week after the 2nd dose is able to neutralize the Delta variant better than the Beta variant. Whether efficacy rates will be influenced by the apparent greater infectivity of the Delta variant remains to be determined.</p>\n<p>\n  New variants continue to arise (Alpha, Gamma, Epsilon, Zeta, Eta, Theta, Iota, Kappa and Lambda and it is clear that potent vaccines are needed, not only to protect the population from the medical complications of COVID-19, but also to determine if the vaccines being used are potent enough to prevent breakthrough acquisitions by multimutational variants.</p>\n<p>\n The relative risks that COVID-19 poses to People living with HIV (PLWH) compared to HIV-uninfected individuals is an area of active research. It is unclear that HIV status is a significant risk factor for poor outcomes from COVID-19 disease. Some of the largest studies examining HIV status and the risk of severe COVID-19 illness have reached inconsistent conclusions.</p>\n<p>\n The optimal COVID-19 mRNA vaccination regimen for PLWH is unknown. Moreover, there are no randomized controlled trials in any stage of vaccine development devoted to defining the efficacy endpoints of a COVID-19 vaccine among PLWH. PLWH are a major focus of this study given the current significant evidence gap regarding what vaccine regimens would best benefit this group. PLWH will constitute the largest proportion of the study population.</p>\n<p>\n We aim to test the safety and efficacy of Moderna’s mRNA vaccine in 14,000 participants recruited from eight African countries; 300 will be recruited in Kisumu. Participants will be over age 18 years with at least one comorbidity associated with severe COVID-19, or over 18 years of age and HIV-infected.</p>\n<p>\n The objective of this randomized, double-blind trial is to assess several regimens of the Moderna COVID-19 vaccine (mRNA-1273) vaccine in PLWH while differentiating between whether participants have a prior history of SARS-CoV-2 infection over 18 months. All participants will receive the vaccine. Participants will be grouped based on their HIV and SARS-CoV-2 serostatus at screening and then randomized 1:1 to either a 3-dose vs 2-dose vaccine regimen or 1-dose vs 2-dose vaccine regimen  CDC Africa encouraged testing various vaccines in the continent to be sure they are efficacious. The World Health Organization has recently listed the Moderna vaccine for emergency use listing. To date, mRNA vaccines have only recently been deployed in the African continent. If this trial is successful, it will provide a new weapon to control the pandemic in Africa and yield critical information on its efficacy against the new variants emerging in Kenya, including the B.1.351 and Delta variants of concern, as well as characterize an optimal COVID-19 mRNA vaccination regimen for PLWH.</p>\n
      • study_title<p>\n Multi-Center, Randomized, Efficacy Study of COVID-19 mRNA Vaccine in Regions with SARS-CoV-2 Variants of Concern</p>\n
      • laymans_summary<p>\n As at 26 Mar 2021, after the first COVID-19  case was confirmed in Kenya on 12 March 2020, a total of 126,170 confirmed cases have been  identified and 2,092  people have died giving a death rate of  1.7 persons per 100 people infected.</p>\n<p>\n The vaccine developed by Moderna and  based on the genetic information of the orignal viral strain that originated in Wuhan, China, was proven to be highly effective in preventing COVID-19 infections. It received an Emergency Use Authorization by the Food & Drug Administration and is now widely used in the USA but has not been used in the African continent. The Africa CDC has encouraged nations in its continent to test the effectiveness and safety of a variety of vaccines in their populations.</p>\n<p>\n As SARS-CoV-2 – the virus that causes COVID-19 – spreads around the globe, it is mutating. It changes in response to the different immune responses in different people. It changes to form new versions of the virus known as ‘variants’. Some examples include the ‘B1.1.7 or Alpha variant’ first discovered in the United Kingdom , the ‘B.1.351 or Beta variant’, first identified in South Africa and the ‘B.1.617 or Delta variant’ first identified in India. It is therefore important to assess whether the ability of the Moderna vaccine to prevent COVID-19 will be affected. The Moderna vaccine contains genetic material from the virus that causes COVID-19 that gives our bodies’ cells instructions for how to make a harmless protein that is unique to the virus. After our cells make copies of the protein, they destroy the genetic material from the vaccine. Our bodies recognize that the protein should not be there and increase immune cells that will remember how to fight the virus that causes COVID-19 if we are infected in the future. The immune cells produce substances known as antibodies which can stop a virus from infecting the body by affecting how the molecules on the virus’ surface can enter cells in the body.</p>\n<p>\n The SARS-CoV-2 South African variant has changes known to reduce how well the antibodies produced by some COVID-19 vaccines work. At this time, it is not clear whether the presence of such variants reduce how well the Moderna vaccine works to cause widespread vaccine failure. However as mentioned above, the vaccine also triggers formation of immune cells which may provide enough protection. It is also possible that the high amount of antibodies produced by the Moderna vaccine will provide enough protection despite reduced sensitivity of the South African virus.</p>\n<p>\n Since the South African and Indian variant are present and increasing in the Eastern and Southern African Region, it is important to perform a study evaluating the effectiveness of the Moderna vaccine. The study will assess the impact of the vaccine developed against the original virus on both moderate and severe disease and death in these regions among adults who are at high risk of severe disease. The study will also carefully examine breakthrough infections in fully vaccinated individuals. A breakthrough infection is a case of illness in which a vaccinated individual becomes sick from the same illness that the vaccine is meant to prevent. This is important so as to determine whether vaccines need to be tailor made for the different variants of concern  or if vaccines need to be modified to accommodate changes for universally effective vaccines, or whether the original vaccine will provide higher protection against severe disease when administered as a booster. (A booster dose is an extra administration of a vaccine after an earlier dose. It is intended to increase immunity after memory against a virus that may have declined over time.) This study will involve people who are at high risk for COVID-19.</p>\n<p>\n PLWH will be the largest group of people enrolled into the study. This is due to current insufficient scientific evidence about what vaccine schedule would best benefit PLWH.</p>\n<p>\n This trial is designed as a 2- versus 3- dose vaccine regimen in participants who have never been infected with SARS-CoV-2 (Groups 1 and 3) .It will compare 2 doses versus 1 dose of vaccine in participants who had a previous infection without symptoms and have a positive SARS-CoV-2 antibody test (Groups 2 and 4).</p>\n<p>\n The study aims to enroll approximately 14,000 participants, 12,600 people living with HIV and 1,400 HIV-negative participants. Among these, 5,000 participants will be confirmed to have a positive SARS-CoV-2 antibody test at screening.</p>\n<p>\n At screening, participants will be grouped based on their HIV status and whether they have a positive SARS-CoV-2 antibody test that indicates previous infection or not. They will then be grouped equally and randomly in a ratio of 1:1 to either a 3-dose vs 2-dose vaccine schedule or 1-dose vs 2-dose vaccine schedule.</p>\n<p>\n All participants will receive vaccine during this trial. At month 6 after enrollment, some participants will receive placebo, while some will receive vaccine. This depends on their randomization group.</p>\n
      • short_titleCoVPN 3008
      • protocol_noECCT/22/01/02
      • version_noVersion 4.0
      • date_of_protocol01-10-2021
      • study_drugCOVID-19 mRNA Vaccine
      • disease_conditionCOVID-19
      • product_type_biologicals1
      • product_type_proteins0
      • product_type_immunologicals0
      • product_type_vaccines1
      • product_type_hormones0
      • product_type_toxoid0
      • product_type_chemical0
      • product_type_medical_device0
      • product_type_chemical_name
      • product_type_medical_device_name
      • comparatorYes
      • comparator_nameplacebo: sodium chloride 0.9% for injection
      • comparator_registered
      • comparator_countries
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressirenekayilah1@gmail.com
      • applicant_covering_letter1
      • applicant_protocol1
      • applicant_patient_information1
      • applicant_investigators_brochure1
      • applicant_investigators_cv1
      • applicant_signed_declaration1
      • applicant_financial_declaration1
      • applicant_gmp_certificate1
      • applicant_indemnity_cover1
      • applicant_opinion_letter1
      • applicant_approval_letter1
      • applicant_statement1
      • applicant_participating_countries(null)
      • applicant_addendum1
      • applicant_fees1
      • applicant_complete_form(null)
      • applicant_impd1
      • applicant_prev_data1
      • applicant_stability_data1
      • applicant_analysis_cert1
      • applicant_pictorial_sample1
      • applicant_gcp_training1
      • applicant_dsmb_charter1
      • applicant_detailed_budget1
      • applicant_indemnity_pi1
      • applicant_practice_license1
      • applicant_registration_ctr(null)
      • applicant_pan_african1
      • applicant_hard_copies(null)
      • applicant_signed_checklist1
      • statistical_analysis_plan1
      • applicant_contractual_agreement1
      • declaration_applicantDr.Ben Andagalu
      • declaration_date114-01-2022
      • declaration_principal_investigatorTaraz Samandari
      • declaration_date214-01-2022
      • placebo_presentYes
      • study_objectives<p>\n 1.To assess the relative vaccine efficacy (RVE) of a 3- vs. 2-dose COVID-19 mRNA vaccine regimen to prevent virologically confirmed symptomatic COVID-19 in adult PLWH who are SARS-CoV-2 negative1 at baseline (Group 1), counting endpoints at least 14 days after Month 6 dose through end of follow-up</p>\n<p>\n 2.To assess the relative vaccine efficacy (RVE) of a 3- vs. 2-dose COVID-19 mRNA vaccine regimen to prevent severe COVID-19 in adult PLWH who are SARS-CoV-2 negative1 at baseline (Group 1), counting endpoints at least 14 days after Month 6 dose through end of follow-up. </p>\n<p>\n 3.To assess the safety and tolerability of COVID19 mRNA vaccine in adults who are at risk of severe COVID-19</p>\n
      • principal_inclusion_criteria<p>\n 1. Age ≥ 18 years if volunteer self-reports they are living with HIV and/or have at least one comorbidity known to be associated with severe COVID-19, for example (CDC.gov for exhaustive list):</p>\n<p>\n • Hypertension</p>\n<p>\n • Type 2 diabetes mellitus</p>\n<p>\n • Obesity (body mass index [BMI] of 30 kg/m2 or higher but < 40 kg/m2)</p>\n<p>\n • Severe Obesity (BMI ≥ 40 kg/m2)</p>\n<p>\n • Heart conditions, such as heart failure, coronary artery disease, or cardiomyopathies</p>\n<p>\n • Chronic kidney disease</p>\n<p>\n • COPD (chronic obstructive pulmonary disease) CoVPN 3008 (Ubuntu) Version 4.0 / October 1, 2021 CoVPN3008_v4.0_FINAL_Oct1_2021 / Page 54 of 134</p>\n<p>\n • Cancer</p>\n<p>\n • Non-HIV immunocompromised state (weakened immune system) or solid organ transplant</p>\n<p>\n • Pregnancy</p>\n<p>\n • Sickle cell disease</p>\n<p>\n • Smoking</p>\n<p>\n 2. Willingness to be followed and remain in the catchment area for the planned duration of the study.</p>\n<p>\n 3. Ability and willingness to provide informed consent.</p>\n<p>\n 4. Willingness to discuss HIV infection status, undergo related testing/monitoring labs, and receive counseling and referrals to minimize HIV acquisition/improve HIV care, as appropriate based on their infection status.</p>\n<p>\n 5. Assessment of understanding: volunteer demonstrates understanding of this study; completes a questionnaire prior to first vaccination with demonstration of understanding of all questionnaire items answered incorrectly.</p>\n<p>\n 6. Agrees not to enroll in another study of an investigational research agent until the end of the study. Enrollment in studies of investigational research agents for the treatment of COVID-19 is allowed for participants who develop COVID-19 disease. </p>\n
      • principal_exclusion_criteria<p>\n 1. Acutely ill 72 hours prior to or at screening. Volunteers meeting this criterion may be rescheduled within the relevant window periods. Participants with minor illnesses can be enrolled at the discretion of the investigator.</p>\n<p>\n 2. History of angioedema or anaphylaxis.</p>\n<p>\n 3. Self-reported previous COVID-19 diagnosis. Vaccines and other Injections</p>\n<p>\n 4. Prior receipt of a SARS-CoV-2 vaccine. CoVPN 3008 (Ubuntu) Version 4.0 / October 1, 2021 CoVPN3008_v4.0_FINAL_Oct1_2021 / Page 55 of 134</p>\n<p>\n 5. History of severe allergic reaction to any ingredient of this vaccine (lipids (SM-102, polyethylene glycol [PEG] 2000 dimyristoyl glycerol [DMG], cholesterol, and 1,2-distearoyl-sn-glycero-3-phosphocholine [DSPC]), tromethamine, tromethamine hydrochloride, acetic acid, sodium acetate trihydrate, and sucrose).</p>\n<p>\n 6. Live attenuated vaccines received within 30 days before first vaccination (eg, measles, mumps, and rubella [MMR]; oral polio vaccine [OPV]; varicella; yellow fever; live attenuated influenza vaccine, live attenuated zoster vaccine).</p>\n<p>\n 7. Any vaccines that are not live attenuated vaccines and were received within 14 days prior to first vaccination (eg, tetanus, human papilloma virus (HPV), pneumococcal, Hepatitis A or B).</p>\n<p>\n 8. Blood products, systemic immunoglobulins, or monoclonal antibodies (including against SARS-CoV-2) received within 90 days before first vaccination. </p>\n
      • primary_end_points<p>\n 1. COVID-19: Positive result of acute SARSCoV-2 infection as assessed by nucleic acid amplification testing (NAAT) of a nasal swab whose collection was triggered by a prespecified symptom or symptoms (see footnote 2)</p>\n<p>\n 2.Severe COVID-19: COVID-19 that meets the criteria listed in footnote 3 AND adjudicated by an independent endpoint adjudication committee</p>\n<p>\n 3.Adverse events: Solicited and unsolicited AEs collected for a subset of study participants. Serious adverse events (SAEs), adverse events of special interest (AESIs), collected for all participants throughout the study </p>\n
      • scope_diagnosis0
      • scope_prophylaxis0
      • scope_therapy0
      • scope_safety1
      • scope_efficacy1
      • scope_pharmacokinetic0
      • scope_pharmacodynamic1
      • scope_bioequivalence0
      • scope_dose_response0
      • scope_pharmacogenetic0
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic0
      • scope_others0
      • scope_others_specify
      • trial_human_pharmacology0
      • trial_administration_humans0
      • trial_bioequivalence_study0
      • trial_other0
      • trial_other_specify
      • trial_therapeutic_exploratory1
      • trial_therapeutic_confirmatory0
      • trial_therapeutic_use0
      • design_controlledYes
      • site_capacity(null)
      • staff_numbers<p font-size:=\"\" font-variant-east-asian:=\"\" font-variant-numeric:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n Site Facilities: 35 Facilities out of which 6 can hospitalize. Kombewa County Hospital is the referral point for all the facilities in Seme sub County, while Chulaimbo is the referral facility in Kisumu West County. The patients are referred to Jaramogi Oginga Odinga Teaching and referral hospital, Avenue Hospital, in case of an emergency.</p>\n<p font-size:=\"\" font-variant-east-asian:=\"\" font-variant-numeric:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n The unit  has the following staff for the study,  4 paedricians, 4 medical offices, 4 clinical offices, 2 study coordinators,7 Lab technologist, 9 nurses, 1 phamacist, 2 phamacy technologist, 8 data clearks and 38 filedworkers.The unit has two storey building consisiting of office space, lab, clinical rooms, archives.</p>\n
      • other_details_explanation<p>\n COVID-19 is a psndemic hence COVID-19 trials are being conducted across multiple sites in Africa.</p>\n
      • other_details_regulatory_notapproved<p>\n KEMRI- SERU(Scientific and Ethics Review Unit.</p>\n
      • other_details_regulatory_approved<p>\n Kenya Pharmacy and Poisons Board</p>\n
      • other_details_regulatory_rejected<p>\n None</p>\n
      • other_details_regulatory_halted<p>\n None</p>\n
      • estimated_duration1 year
      • design_controlled_randomisedYes
      • design_controlled_openNo
      • design_controlled_single_blindNo
      • design_controlled_double_blindYes
      • design_controlled_parallel_groupNo
      • design_controlled_cross_overNo
      • design_controlled_otherYes
      • design_controlled_specifyImmediate vs deferred vaccination with blinded crossover
      • design_controlled_comparatorSodium chloride 0.9%
      • design_controlled_other_medicinalNo
      • design_controlled_placeboNo
      • design_controlled_medicinal_otherNo
      • design_controlled_medicinal_specify
      • single_site_member_stateNo
      • location_of_area
      • single_site_physical_address
      • single_site_contact_person
      • single_site_telephone
      • multiple_sites_member_stateYes
      • multiple_countriesYes
      • multiple_member_states7
      • number_of_sites2
      • multi_country_listBotswana, Uganda, Kenya, Malawi,Eswatini,South Africa,Zimbabwe
      • data_monitoring_committeeYes
      • total_enrolment_per_site300
      • total_participants_worldwide14,000
      • population_less_than_18_yearsNo
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerNo
      • population_childrenNo
      • population_adolescentNo
      • population_above_18Yes
      • population_adultYes
      • population_elderlyYes
      • gender_female1
      • gender_male1
      • subjects_healthyNo
      • subjects_patientsYes
      • subjects_vulnerable_populationsYes
      • subjects_women_child_bearingYes
      • subjects_women_using_contraceptionYes
      • subjects_pregnant_womenNo
      • subjects_nursing_womenNo
      • subjects_emergency_situationNo
      • subjects_incapable_consentNo
      • subjects_specify
      • subjects_othersYes
      • subjects_others_specifyAge 40 and at least one comorbidity known to be associated with severe COVID-19\nAge ≥ 18 and pregnant\nAge ≥ 18 and HIV infected
      • investigator1_given_nameTaraz
      • investigator1_middle_name
      • investigator1_family_nameSamandari
      • investigator1_qualificationMD, PhD
      • investigator1_professional_addressKEMRI Centre for Global Health Research (CGHR), P.O. Box 1578, Kisumu, Kenya
      • investigator1_telephone+254-57-2022929/02/59/83
      • investigator1_emailtts0@cdc.gov
      • organisations_transferred_No
      • number_participants500
      • notification
      • approval_date14-04-2022
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted15-02-2022
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reasonThe queries raised have been addressed
      • final_report(null)
      • implication_results(null)
      • quantity_imported(null)
      • quantity_dispensed(null)
      • quantity_destroyed(null)
      • quantity_exported(null)
      • balance_site(null)
      • final_date(null)
      • modified2024-06-28 15:50:57
      • created2022-01-05 09:51:10
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id783
        • application_id1108
        • given_nameBen
        • middle_nameMadeke
        • family_nameAndagalu
        • qualificationMD
        • professional_addressKEMRI-USAMRD-A,P.O.BOX 54-40100 Kisumu
        • telephone+254716004851
        • emailben.andagalu@usamru-k.org
        • created2022-01-05 10:31:54
        • modified2022-02-15 14:30:41
    • SiteDetail(array)
      • 0(array)
        • id1226
        • application_id1108
        • county_id42
        • site_nameKEMRI -USAMRD-A, Kombewa Clinical Research Centre
        • physical_addressOff Kisumu Bondo Road, Opposite Kombewa County Hospital
        • contact_detailsP.O.Box 54-40100 Kisumu
        • contact_personDr.Ben Andagalu
        • site_capacity(null)
        • misc(null)
        • created2022-01-05 10:31:54
        • modified2022-02-15 14:30:41
        • County(array)
          • id42
          • county_nameKisumu
          • created2012-06-15 10:27:02
          • modified2012-06-15 10:27:02
      • 1(array)
        • id1227
        • application_id1108
        • county_id42
        • site_nameKEMRI-CGHR
        • physical_addressJaramogi Oginga Odinga Teaching and Referal Hospital
        • contact_detailsP.O.Box 1578 Kisumu
        • contact_personDr.Grace Mboya
        • site_capacity(null)
        • misc(null)
        • created2022-01-05 11:06:59
        • modified2022-02-15 14:30:41
        • County(array)
          • id42
          • county_nameKisumu
          • created2012-06-15 10:27:02
          • modified2012-06-15 10:27:02
    • Sponsor(array)
      • 0(array)
        • id572
        • application_id1108
        • sponsorSouth African Medical Research Council
        • sponsor_typeOthers
        • contact_person
        • addressFrancie Van Zijl Drive parowvallei, cape town P.O.Box 19070 7505 Tygerberg, South Africa
        • telephone_number+27219380911
        • fax_number
        • cell_number+27219380911
        • email_addressinfo@mrc.ac.za
        • created2022-01-05 10:31:54
        • modified2022-02-15 14:30:41
  • 2(array)
    • Application(array)
      • id1079
      • user_id71
      • trial_status_id3
      • abstract_of_study<p>\n Summary Background: WHO helps evaluate drugs by randomising their effects on important outcomes. The WHO Solidarity trial involves collaboration between hundreds of hospitals in dozens of countries. It began by evaluating four repurposed drugs, and now guided by an independent Expert Groups, is now evaluating addition to the local Standard of Care of other potential drugs. Simplicity of procedures: Within each country, the national co-ordinator invites selected hospitals and helps them get ethical and regulatory approval and study drugs, then patient recruitment can begin. To facilitate collaboration even in overloaded hospitals, patient enrolment and randomisation (via a cloud-based GCP-compliant platform) and all other trial procedures are greatly simplified, and no paperwork is required. Once consent has been obtained, electronic entry of anonymised details of a few key characteristics of each patient takes only a few minutes. At the end of patient entry, a random treatment allocation is generated. Eligibility: Adults (age ≥ 18 years), hospitalised with laboratory-confirmed COVID, not expecting transfer within 72 hours, and, in the view of their doctors, with no contra-indication to any potentially relevant study drug. Consent: The study website https://data.castoredc.com/studies has printable patient information in some UN official languages. Once the information has been explained to patients, obtaining consent takes only a few minutes. An electronic image of the signature page is kept (or, if national regulations forbid this, a note to file), and the printed information and original consent stays with the patient or legal representative. Data collected electronically immediately before randomisation: • Country, hospital (from a list of approved hospitals) and randomising doctor • Confirmation that informed consent was obtained from the patient (or a surrogate/ representative) Age, sex and (yes/no): smoking, diabetes, heart disease, chronic liver disease, chronic lung disease, asthma, HIV, obesity • Date of onset of symptoms, date of hospitalization, and (yes/no) current/planned use of a few drugs • Respiratory support (highest level currently being given): A. No oxygen, B. Low-flow oxygen, C. High-flow nasal oxygen, D. Non-invasive ventilation, E. Invasive ventilation, F. ECMO • SpO2 (%) and, if not ventilated, respiratory rate • Any major bilateral lung abnormality? (not imaged/no major abnormality/infiltrations/patchy shadowing) • Which relevant study drugs are locally available? (yes/no: artesunate, infliximab, imatinib; confirm that none of these locally available drug(s) is, in the doctor’s view, definitely contra-indicated) Trial entry; randomization: Once electronic data collection has been completed the patient automatically enters the trial and a random allocation of their trial treatment is generated (by an algorithm that ensures eventual balance in the characteristics just recorded between each study drug and its controls) and displayed. The patients will be randomly allocated either to Standard of Care (SoC) or to one of the study drugs. Changing management of study patients: At all times the patient’s medical team remains solely responsible for decisions about that patient’s care and safety. Hence, if the team decides that deviation from the randomly allocated treatment is appropriate for a particular patient, this should be done, regardless of the random allocation. That patient would still be part of the trial, regardless of what treatment they were actually given.   Safety: Any suspected unexpected serious adverse reactions (SUSARs) that are life-threatening must be reported within 24 hours, as must any other possibly related treatment-related serious adverse events (SAEs). Other adverse events do not need to be reported. Follow-up: When patients die or are discharged, follow-up ceases and their outcome is reported, regardless of whether the trial treatment actually got given. The following information is to be entered: • Which study drug(s) got given (and for how long) • Which of a few selected other drugs were given (and for how long) • What respiratory support was given (and first and last dates): A No respiratory support, B Low-flow oxygen, C High-flow nasal oxygen, D Non-invasive ventilation, E Invasive ventilation, F ECMO • Date discharged alive or date of death in hospital and cause of death. • Pregnant? Yes/No/unknown Primary and secondary analyses: Primary analyses: In-hospital mortality in all patients. Major secondary analyses: In-hospital mortality subdivided by initial respiratory support. Further secondary analyses: duration of hospital stay in lower-risk patients (A-B); and in higher-risk patients (C-F); and initiation of ventilation in lower-risk patients. The main safety analyses will be of reported SAEs possibly related to the treatment and SUSARs. Numbers entered: The larger the numbers entered the more accurate the results will be. If substantial numbers get hospitalised in the participating centres, it may be possible to enter several thousand hospitalised patients receiving no oxygen or low-flow supplemental oxygen, and a few thousand receiving high-flow nasal oxygen, ventilation or ECMO, but realistic, appropriate sample sizes will not be estimated at the start of the trial; the numbers that can be entered will depend on the evolution of the epidemic. Heterogeneity: If a study treatment affects outcome, then this effect could well differ between patients who were receiving different levels of respiratory support when randomised, and separate consideration of these is a secondary analysis. Effects could also differ between younger and older patients, or between patients in one or another country or geographic region. If sufficient numbers are randomised, it may be possible to obtain statistically reliable treatment comparisons within each of several different countries/regions or types of patient. Adaptive design: A global Data and Safety Monitoring Committee will keep the accumulating safety results and major outcome results under regular review. The WHO may recommend adding further treatment arms while the trial is in progress, if evidence emerges that there are suitable candidate therapeutics. Conversely, the WHO may decide to discontinue some treatment arms, especially if the Global Data and Safety Monitoring Committee reports, based on interim analyses, that one or other of the trial treatments definitely does or does not affect mortality. Add-on studies: Particular countries, or particular groups of hospitals, may want to collaborate in making further measurements or observations, such as serial virology, serial blood gases or chemistry, serial lung imaging, or serial documentation of other aspects of disease status of trial patients (perhaps through linkage to electronic healthcare records and routine medical databases). These could be thought of as Phase 2b trials that are being conducted concurrently with the Phase 3 trial. However, while well-organised additional research studies of the natural history of the disease or the effects of the trial treatments could well be valuable, they are not core requirements. Data security: Patient information will be encrypted and held securely by the WHO. Those analysing it will use only anonymised data, and no identifiable patient details will appear in publications. Publication: This international collaboration is co-ordinated through the World Health Organisation. Major findings will be disseminated by the WHO and published in the names of the collaborators.</p>\n
      • study_title<p>\n An international randomised trial of additional treatments for COVID-19 in hospitalised patients who are all receiving the local standard of care</p>\n
      • laymans_summary<p>\n We are conducting a study to find out the best treatments for COVID-19. Several medicines for it have been proposed. These medicines may have no effect or a moderate effect on the disease, but none is expected to have a big effect. This hospital is collaborating through the World Health Organization and hospitals in many other countries in a study to help discover whether any of these treatments can help</p>\n
      • short_titleSOLIDARITY TRIAL PLUS
      • protocol_noECCT/21/11/05
      • version_no1.0
      • date_of_protocol05-04-2021
      • study_drugArtesunate, Infliximab:Imatinib
      • disease_conditionCovid-19
      • product_type_biologicals1
      • product_type_proteins1
      • product_type_immunologicals0
      • product_type_vaccines0
      • product_type_hormones0
      • product_type_toxoid0
      • product_type_chemical0
      • product_type_medical_device0
      • product_type_chemical_name
      • product_type_medical_device_name
      • comparatorNo
      • comparator_name
      • comparator_registered
      • comparator_countries
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressjnyange@kaviuon.org
      • applicant_covering_letter1
      • applicant_protocol1
      • applicant_patient_information1
      • applicant_investigators_brochure1
      • applicant_investigators_cv1
      • applicant_signed_declaration1
      • applicant_financial_declaration1
      • applicant_gmp_certificate1
      • applicant_indemnity_cover1
      • applicant_opinion_letter1
      • applicant_approval_letter1
      • applicant_statement1
      • applicant_participating_countries(null)
      • applicant_addendum1
      • applicant_fees1
      • applicant_complete_form(null)
      • applicant_impd0
      • applicant_prev_data1
      • applicant_stability_data1
      • applicant_analysis_cert1
      • applicant_pictorial_sample1
      • applicant_gcp_training1
      • applicant_dsmb_charter1
      • applicant_detailed_budget1
      • applicant_indemnity_pi1
      • applicant_practice_license1
      • applicant_registration_ctr(null)
      • applicant_pan_african1
      • applicant_hard_copies(null)
      • applicant_signed_checklist1
      • statistical_analysis_plan1
      • applicant_contractual_agreement1
      • declaration_applicantDr Loice Ombajo
      • declaration_date112-11-2021
      • declaration_principal_investigatorDr Loice Ombajo
      • declaration_date212-11-2021
      • placebo_presentNo
      • study_objectives<p>\n The primary outcome is in-hospital mortality from any cause, and the primary analyses are of mortality in all randomised patients. The major secondary outcomes are initiation of ventilation, and duration of hospital stay. The main safety analyses will be of reported SAEs and SUSARs possibly related to the treatment and SUSARs. Numbers of deaths in hospital attributed to causes other than COVID-19 will also be reported. It is not expected that any of the treatments currently being tested will have a large effect on the risk of death, but if any had just a moderate effect and was widely practicable then this could avoid large numbers of deaths. Conversely, demonstration that certain agents have no material effect on major outcomes would be of value. Moderate effects can, however, be reliably demonstrated or refuted only by large-scale randomized evidence.</p>\n
      • principal_inclusion_criteria<p>\n Eligibility o adults (age ≥18 years, which allows consent), o recently hospitalised (or already in hospital) with laboratory-confirmed COVID, o not expected to be transferred within 72 hours, o with, in the view of their doctors, no contra-indication to any potentially relevant study drug.</p>\n
      • principal_exclusion_criteria<p>\n Contraindication to any of the study drugs, expected transfer withing 72 hours of enrollment</p>\n
      • primary_end_points<p>\n This is an open-label randomised controlled trial that will randomise COVID-19 positive patients to either continu-ing local standard of care or enrolling one of three intervention arms: Artesunate, Imatinib or Infliximab. Collated international data will be analysed for mortality and duration of hospital stay and need for ventilatory support</p>\n
      • scope_diagnosis0
      • scope_prophylaxis0
      • scope_therapy1
      • scope_safety1
      • scope_efficacy1
      • scope_pharmacokinetic0
      • scope_pharmacodynamic0
      • scope_bioequivalence0
      • scope_dose_response0
      • scope_pharmacogenetic0
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic0
      • scope_others0
      • scope_others_specify
      • trial_human_pharmacology0
      • trial_administration_humans0
      • trial_bioequivalence_study0
      • trial_other0
      • trial_other_specify
      • trial_therapeutic_exploratory1
      • trial_therapeutic_confirmatory0
      • trial_therapeutic_use0
      • design_controlledYes
      • site_capacity(null)
      • staff_numbers<p>\n 2. KNH WHO SOLIDARITY TRIAL STUDY SETTING/SITE The KNH-Infectious Disease Unit (IDU) was established in 2014 as part of the response towards the Ebola Virus Disease outbreak in West Africa (2014 to 2017). Some of the health care workers in KNH-IDU served for more than 1 year in the West African Ebola response. The KNH study site has 3 COVID-19 dedicated facilities for the care of COVID-19 patients. These are the KNH-IDU Unit (6-bed ICU facility), the KNH-Mbagathi IDU facility (60-bed facility for the care of COVID-19 patients including 8 HDU beds) and the KNH Day Care Unit (20-bed facility for the management of HCWs who get infected with COVID-19). 2.1. Standard of Care The KNH IDU offers standard of care as per the Interim National Case Management Guidelines. In addition, patients admitted to the units have access to on-site chest radiography/ imaging and laboratory services. Baseline tests (Full blood count, renal and liver biochemistry) are obtained for all admitted patients. Thereafter, repeat tests are done when clinically indicated. 2.2. KNH-IDU Facilities Staff All the KNH-IDU facilities are staffed by a multidisciplinary team of dedicated and experienced HCWs trained in COVID-19 management and infection prevention and control management including safe donning and doffing of PPE. The KNH-IDUs are staffed by a dedicated team of Infectious diseases specialists and fellows, Medical officers, nurses, pharmacists, pharmaceutical technicians, counselors, physiotherapists, laboratory technologists, health information officers, nutritionists, catering and support staff. 2.3. Healthcare Worker Safety All these healthcare workers are trained in infection prevention and control and doffing and donning of PPE. The safety protocols include twice daily temperature monitoring and logging, daily symptomatic screening, buddy system for donning and doffing of PPE and team-work while entering the isolation units. Testing and re-testing of the HCWs will be done as per guidelines in the MOH COVID-19 human resource for health (HRH) protocols. Furthermore, KNH has identified and developed the KNH Day Care Unit as a facility for the care of HCWs who get infected with COVID-19 in the line of duty</p>\n<p>\n 3.0 STAFFING The Nairobi hospital has over 2000 staff members. These are members in both clinical and non-clinical departments and together they ensure the smooth running of the hospital and the highest level of care for the patients. The East wing has staff of all cadres, including doctors (both medical officers and specialists) nurses, physiotherapists, counsellors, occupation therapists and all other non-medical supporting staff. The staff ratios in the covid unit are fluid. We have three permanent consultants employed by the hospital. We also have 3 permanent Senior Registrars in Internal Medicine and 21 permanent medical officers. There is capacity to increase the numbers in the event of a surge of patients. The nurses are such that there is a nursing ratio of 1:1 in the Intensive Care Unit and also enough for the wards to give a comfortable nursing ratio. There is also capacity to increase the numbers of nursing staff depending on patient numbers. We also have physiotherapists and occupational therapist. We have radiologist on call and have a portable Xray and portable ultrasound machine</p>\n
      • other_details_explanation<p>\n No</p>\n
      • other_details_regulatory_notapproved<p>\n None</p>\n
      • other_details_regulatory_approved<p>\n None</p>\n
      • other_details_regulatory_rejected<p>\n None</p>\n
      • other_details_regulatory_halted<p>\n N/A</p>\n
      • estimated_duration11 months
      • design_controlled_randomisedYes
      • design_controlled_openNo
      • design_controlled_single_blindNo
      • design_controlled_double_blindNo
      • design_controlled_parallel_groupYes
      • design_controlled_cross_overNo
      • design_controlled_otherNo
      • design_controlled_specify
      • design_controlled_comparatorStandard of Care (SoC)
      • design_controlled_other_medicinalNo
      • design_controlled_placeboNo
      • design_controlled_medicinal_otherNo
      • design_controlled_medicinal_specify
      • single_site_member_stateNo
      • location_of_area
      • single_site_physical_address
      • single_site_contact_person
      • single_site_telephone
      • multiple_sites_member_stateYes
      • multiple_countriesNo
      • multiple_member_states
      • number_of_sites2
      • multi_country_list
      • data_monitoring_committeeYes
      • total_enrolment_per_siteThis is a global trial, each site will enrol as many patients as it takes to be able to answer the objectives
      • total_participants_worldwideThis is a global trial, each site will enrol as many patients as it takes to be able to answer the objectives
      • population_less_than_18_yearsNo
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerNo
      • population_childrenNo
      • population_adolescentNo
      • population_above_18Yes
      • population_adultYes
      • population_elderlyYes
      • gender_female1
      • gender_male1
      • subjects_healthyNo
      • subjects_patientsYes
      • subjects_vulnerable_populationsYes
      • subjects_women_child_bearingYes
      • subjects_women_using_contraceptionYes
      • subjects_pregnant_womenYes
      • subjects_nursing_womenYes
      • subjects_emergency_situationYes
      • subjects_incapable_consentNo
      • subjects_specify
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameloice
      • investigator1_middle_name
      • investigator1_family_nameOmbajo
      • investigator1_qualificationMBChB, MMed, MSc, DLSHTM
      • investigator1_professional_addressP.O box 19676
      • investigator1_telephone0722576984
      • investigator1_emailloicea.la@gmail.com
      • organisations_transferred_No
      • number_participantsThis is a global trial, each site will enrol as many patients as it takes to be able to answer the objectives
      • notification
      • approval_date13-01-2022
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted12-11-2021
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reasonThe queries raised have been addressed conclusively.
      • final_report(null)
      • implication_results(null)
      • quantity_imported(null)
      • quantity_dispensed(null)
      • quantity_destroyed(null)
      • quantity_exported(null)
      • balance_site(null)
      • final_date(null)
      • modified2024-01-03 15:01:35
      • created2021-11-02 11:46:06
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id744
        • application_id1079
        • given_nameloice
        • middle_name
        • family_nameOmbajo
        • qualification MBChB, MMed, MSc, DLSHTM
        • professional_addressP.O box 19676
        • telephone0722576984
        • emailloicea.la@gmail.com
        • created2021-11-02 11:48:17
        • modified2021-11-12 08:59:54
    • SiteDetail(array)
      • 0(array)
        • id1166
        • application_id1079
        • county_id47
        • site_nameKENYATTA NATIONAL HOSPITAL SITE
        • physical_addressKenyatta National Hospital , Ngong Road
        • contact_details+254 733 729963
        • contact_personDr MaryBeth Maritim
        • site_capacity(null)
        • misc(null)
        • created2021-11-02 11:48:17
        • modified2021-11-12 08:59:54
        • County(array)
          • id47
          • county_nameNairobi City
          • created2012-06-15 10:27:40
          • modified2012-06-15 10:27:40
      • 1(array)
        • id1167
        • application_id1079
        • county_id47
        • site_nameThe Nairobi Hospital
        • physical_addressThe Nairobi Hospital
        • contact_detailsTel +254722806122
        • contact_personDr Jackline Odhiambo
        • site_capacity(null)
        • misc(null)
        • created2021-11-03 21:55:12
        • modified2021-11-12 08:59:54
        • County(array)
          • id47
          • county_nameNairobi City
          • created2012-06-15 10:27:40
          • modified2012-06-15 10:27:40
    • Sponsor(array)
      • 0(array)
        • id551
        • application_id1079
        • sponsorWHO
        • sponsor_typeOthers
        • contact_personDr. Salami Kolawole
        • addressCH-1211 Geneva 27, Switzerland
        • telephone_number+41227913744
        • fax_number
        • cell_number+41 79 684 00 69
        • email_addresssalamik@who.int
        • created2021-11-02 11:48:17
        • modified2021-11-12 08:59:54
  • 3(array)
    • Application(array)
      • id1046
      • user_id501
      • trial_status_id(null)
      • abstract_of_study<p>\n <strong><u>Objectives</u></strong></p>\n<p>\n Primary Aim: To validate the functionality of Chloe SED, a novel, low-cost, non-invasive syringe extension device for provision of paracervical analgesia during MVA in a single-blind block randomized controlled clinical trial.  Functionality will be assessed via measurement of patient pain levels during MVA utilizing either the syringe extension device (experimental arm) or standard spinal needle (control arm) to administer paracervical analgesia.</p>\n<p>\n  </p>\n<p>\n Secondary Aims:</p>\n<ol>\n <li>\n To assess safety of the syringe extension device via data collection on adverse outcomes.</li>\n <li>\n To assess provider’s experiences and opinions regarding use of the syringe extension device compared with the standard spinal needle administered block.</li>\n <li>\n To gather feedback on device design and improve upon the current model.</li>\n <li>\n To understand the acceptability and feasibility of device use and testing in western Kenya, including acceptance of the study population of randomization and blinding.</li>\n <li>\n To establish and strengthen research collaborations with the UIC School of Public Health and with community partners at Nyanza Reproductive Health Society in Kenya. These partnerships will be critical in further device testing, and for development of new future women’s health innovations.</li>\n <li>\n To assess patients’ experiences and preferences during MVA</li>\n</ol>\n
      • study_title<p>\n Validation of Chloe SED, a reusable, low-cost syringe extension device for the provision of paracervical analgesia during gynecologic procedures </p>\n
      • laymans_summary<p>\n In many rural clinics providing women’s health services, paracervical block is impossible to perform due to the high cost of necessary tools (spinal needle, needle extender).  In these situations, women undergo manual vacuum aspiration (MVA) and other gynecologic procedures without paracervical analgesia.  We have developed a low-cost, reusable syringe extension device for the provision of paracervical analgesia during MVA.  Our initial pilot study of the device revealed that in a small sample size of 60, it is safe and non-inferior in efficacy to the standard spinal needle which is the current gold standard tool in administration of paracervical block.  We propose to further validate functionality of the device and collect user feedback from women’s health providers and patients at two sites in Western, Kenya.</p>\n
      • short_titleValidation of Chloe SED
      • protocol_noECCT/21/10/03
      • version_no1
      • date_of_protocol11-08-2021
      • study_drugChloe SED, a syringe extension device
      • disease_conditionPain during manual vacuum aspiration (MVA)
      • product_type_biologicals0
      • product_type_proteins0
      • product_type_immunologicals0
      • product_type_vaccines0
      • product_type_hormones0
      • product_type_toxoid0
      • product_type_chemical0
      • product_type_medical_device1
      • product_type_chemical_name
      • product_type_medical_device_nameChloe SED
      • comparatorNo
      • comparator_name
      • comparator_registered
      • comparator_countries
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressgwerso@yahoo.co.uk
      • applicant_covering_letter1
      • applicant_protocol1
      • applicant_patient_information1
      • applicant_investigators_brochure1
      • applicant_investigators_cv1
      • applicant_signed_declaration1
      • applicant_financial_declaration1
      • applicant_gmp_certificate1
      • applicant_indemnity_cover1
      • applicant_opinion_letter1
      • applicant_approval_letter1
      • applicant_statement1
      • applicant_participating_countries(null)
      • applicant_addendum1
      • applicant_fees1
      • applicant_complete_form(null)
      • applicant_impd1
      • applicant_prev_data1
      • applicant_stability_data1
      • applicant_analysis_cert1
      • applicant_pictorial_sample1
      • applicant_gcp_training1
      • applicant_dsmb_charter1
      • applicant_detailed_budget1
      • applicant_indemnity_pi1
      • applicant_practice_license1
      • applicant_registration_ctr(null)
      • applicant_pan_african1
      • applicant_hard_copies(null)
      • applicant_signed_checklist1
      • statistical_analysis_plan1
      • applicant_contractual_agreement1
      • declaration_applicantStephen Gwer
      • declaration_date112-10-2021
      • declaration_principal_investigatorStephen Gwer
      • declaration_date212-10-2021
      • placebo_presentNo
      • study_objectives<p>\n <strong><u>Objectives</u></strong></p>\n<p>\n Primary Aim: To validate the functionality of Chloe SED, a novel, low-cost, non-invasive syringe extension device for provision of paracervical analgesia during MVA in a single-blind block randomized controlled clinical trial.  Functionality will be assessed via measurement of patient pain levels during MVA utilizing either the syringe extension device (experimental arm) or standard spinal needle (control arm) to administer paracervical analgesia.</p>\n<p>\n  </p>\n<p>\n Secondary Aims:</p>\n<ol>\n <li>\n To assess safety of the syringe extension device via data collection on adverse outcomes.</li>\n <li>\n To assess provider’s experiences and opinions regarding use of the syringe extension device compared with the standard spinal needle administered block.</li>\n <li>\n To gather feedback on device design and improve upon the current model.</li>\n <li>\n To understand the acceptability and feasibility of device use and testing in western Kenya, including acceptance of the study population of randomization and blinding.</li>\n <li>\n To establish and strengthen research collaborations with the UIC School of Public Health and with community partners at Nyanza Reproductive Health Society in Kenya. These partnerships will be critical in further device testing, and for development of new future women’s health innovations.</li>\n <li>\n To assess patients’ experiences and preferences during MVA</li>\n</ol>\n
      • principal_inclusion_criteria<p>\n <strong>Inclusion criteria for RCT:</strong></p>\n<p style=\"margin-left:.25in;\">\n ●      Women’s health providers providing MVA services at the 2 study sites.</p>\n<p style=\"margin-left:.25in;\">\n ●      Female patients receiving MVA at the two study sites.  These women will be determined clinically eligible for MVA treatment by a licensed Kenyan Medical Officer or Clinical Officer who has evaluated them.</p>\n<p style=\"margin-left:.25in;\">\n ●      Ability to consent and understand that participation in the study involves potential use of a new device during the planned MVA.</p>\n<p style=\"margin-left:.25in;\">\n ●      Age 18 years or greater.</p>\n<p style=\"margin-left:.25in;\">\n  </p>\n<p style=\"margin-left:.25in;\">\n <strong>Inclusion criteria for the focused group discussion of Kenyan women:</strong></p>\n<p>\n ·       Kenyan woman with ability to consent.</p>\n<p>\n ·       Age 18 years or greater.</p>\n<p>\n ·       Have previously had MVA (by patient report or hospital records)</p>\n
      • principal_exclusion_criteria<p>\n <strong>Exclusion criteria for RCT:</strong></p>\n<p>\n Males will be excluded from the patient population as men do not receive MVA services.  Male MVA providers will not be excluded from the provider population.<strong>  Persons under the age of 18 will be excluded.  Any member of the research team (including PI and Co-Is) who is also a women’s health provider will be excluded so as to avoid bias.  </strong>There is no limitation based on race, tribe, religion or sexual orientation in the study for any patients or providers who meet inclusion criteria.  There are no exclusions for patients based on language.  </p>\n<p>\n  </p>\n<p>\n Contraindications to lidocaine or patients with increased risks to MVA procedure (as determined by PPB in the initial pilot study) which include the following:</p>\n<p>\n ·      Known or suspected hypersensitivity to lidocaine</p>\n<p>\n ·      Skin infection adjacent to proposed site of injection (for MVA this would include uterine and cervical infection)</p>\n<p>\n ·      Concomitant anticoagulant therapy or an abnormal bleeding tendency</p>\n<p>\n ·      Severe anemia or heart disease.  Severe anemia will be defined as per the WHO, as anemia associated with symptoms of fatigue, weakness, dizziness, and drowsiness or known haemoglobin concentration less than 7.0 g/dL</p>\n<p>\n  </p>\n<p>\n <strong>Exclusion criteria for focused group discussion of MVA providers:</strong></p>\n<p>\n Age less than 18 years.  There is no limitation based on religion, race, tribe, or sexual orientation in the study for any MVA providers who meet inclusion criteria.  There are no exclusions for MVA providers based on language.</p>\n
      • primary_end_points<p>\n The primary end point will be pain score as assessed by an 11 point Visual Assessment Scale (VAS) duing uterine evacuation. </p>\n
      • scope_diagnosis0
      • scope_prophylaxis0
      • scope_therapy1
      • scope_safety0
      • scope_efficacy0
      • scope_pharmacokinetic0
      • scope_pharmacodynamic0
      • scope_bioequivalence0
      • scope_dose_response0
      • scope_pharmacogenetic0
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic0
      • scope_others0
      • scope_others_specify
      • trial_human_pharmacology0
      • trial_administration_humans0
      • trial_bioequivalence_study0
      • trial_other0
      • trial_other_specify
      • trial_therapeutic_exploratory1
      • trial_therapeutic_confirmatory0
      • trial_therapeutic_use0
      • design_controlledYes
      • site_capacity(null)
      • staff_numbers<p>\n <span style=\"font-family: Calibri, sans-serif; font-size: 12pt; color: black;\">The study population will include women’s health providers who perform MVA and patients requiring manual vacuum aspiration (MVA) at two clinical sites in Kisumu, Kenya: Jaramogi Oginga Odinga Teaching and Referral Hospital, Kisii Teaching and Referral Hospital.  The study team met with the regional directors at each of the sites and confirmed willingness of each site to participate in the study (letters of support included).  Clinical volume and number of MVA providers at each site were confirmed to ensure an adequate number of potential study participants for recruitment within the study period.  Average clinical volume between the five sites is 400 MVA procedures per month with approximately 30 MVA providers available for potential study recruitment.</span></p>\n<p class=\"Body\" style=\"margin: 0in; line-height: 16.866666793823242px; font-size: 11pt; font-family: Arial, sans-serif; color: black; border: none;\">\n <span style=\"font-size: 12pt; line-height: 18.399999618530273px; font-family: Calibri, sans-serif;\"> </span></p>\n<p class=\"Body\" style=\"margin: 0in; line-height: 16.866666793823242px; font-size: 11pt; font-family: Arial, sans-serif; color: black; border: none;\">\n <span style=\"font-size: 12pt; line-height: 18.399999618530273px; font-family: Calibri, sans-serif;\">Jaramogi Oginga Odinga Teaching and Referral Hospital has a maternity complex with 60 beds. MVA providers at this facility include medical officers (MO) and clinical officers (CO).  Other providers staffing the ward including Ob/Gyn physicians, residents, and nursing staff.  There is a procedure room available for MVA procedures and an operating theatre also available.   <o:p></o:p></span><span style=\"font-family: Calibri, sans-serif; font-size: 12pt;\">Kisii Teaching and Referral Hospital has a maternity complex with 68 beds.  A procedure room is available for MVA procedures.  MVA procedures are completed by MOs and COs.  All sites have adequate staff and equipment to carry out the study.  </span></p>\n
      • other_details_explanation<p>\n Kenya is the country of origin of the applicant. </p>\n
      • other_details_regulatory_notapproved<p>\n University of Illinois at Chicago, pending - submitted 14th September 2021</p>\n
      • other_details_regulatory_approved<p>\n JOOTRH ERC - approved 26th August 2021</p>\n
      • other_details_regulatory_rejected<p>\n Not applicable </p>\n
      • other_details_regulatory_halted<p>\n Not applicable </p>\n
      • estimated_duration12 months
      • design_controlled_randomisedYes
      • design_controlled_openNo
      • design_controlled_single_blindYes
      • design_controlled_double_blindNo
      • design_controlled_parallel_groupNo
      • design_controlled_cross_overNo
      • design_controlled_otherNo
      • design_controlled_specify
      • design_controlled_comparatorSpinal needle
      • design_controlled_other_medicinalNo
      • design_controlled_placeboNo
      • design_controlled_medicinal_otherNo
      • design_controlled_medicinal_specify
      • single_site_member_stateNo
      • location_of_area
      • single_site_physical_address
      • single_site_contact_person
      • single_site_telephone
      • multiple_sites_member_stateYes
      • multiple_countriesNo
      • multiple_member_states
      • number_of_sites2
      • multi_country_list
      • data_monitoring_committeeYes
      • total_enrolment_per_siteMinimum 10 patients and 1 provider per site, maximum 200 patients and 20 providers
      • total_participants_worldwide210 patients
      • population_less_than_18_yearsNo
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerNo
      • population_childrenNo
      • population_adolescentNo
      • population_above_18Yes
      • population_adultYes
      • population_elderlyNo
      • gender_female1
      • gender_male0
      • subjects_healthyYes
      • subjects_patientsYes
      • subjects_vulnerable_populationsYes
      • subjects_women_child_bearingYes
      • subjects_women_using_contraceptionNo
      • subjects_pregnant_womenYes
      • subjects_nursing_womenNo
      • subjects_emergency_situationYes
      • subjects_incapable_consentNo
      • subjects_specify
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameStephen
      • investigator1_middle_name
      • investigator1_family_nameGwer
      • investigator1_qualificationChair of Obstetrics and Gynecology, Maseno University
      • investigator1_professional_addressDepartment of Obstetrics and Gynecology, School of Medicine, Maseno University, Private Bag, Maseno
      • investigator1_telephone+254 772 657163
      • investigator1_emailgwerso@gmail.com
      • organisations_transferred_No
      • number_participants210 patients and 21 providers
      • notification
      • approval_date29-04-2022
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted13-10-2021
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reasonThe comments from reviewers have been addressed
      • final_report(null)
      • implication_results(null)
      • quantity_imported(null)
      • quantity_dispensed(null)
      • quantity_destroyed(null)
      • quantity_exported(null)
      • balance_site(null)
      • final_date(null)
      • modified2023-04-20 15:15:48
      • created2021-08-11 21:36:52
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id708
        • application_id1046
        • given_nameStephen
        • middle_name
        • family_nameGwer
        • qualificationChair of Obstetrics and Gynecology, Maseno University
        • professional_addressDepartment of Obstetrics and Gynecology, School of Medicine, Maseno University, Private Bag, Maseno
        • telephone+254 772 657163
        • emailgwerso@gmail.com
        • created2021-08-11 22:07:09
        • modified2021-10-13 00:59:49
    • SiteDetail(array)
      • 0(array)
        • id1091
        • application_id1046
        • county_id42
        • site_nameJaramogi Oginga Odinga Teaching and Referral Hospital (JOOTRH)
        • physical_addressKisumu Kakamega highway
        • contact_detailsP.O. Box 849 - 40100 Kisumu Tel +254-57-2020801
        • contact_personDr. Dedan Ongong\'a
        • site_capacity(null)
        • misc(null)
        • created2021-08-11 22:07:09
        • modified2021-10-13 00:59:49
        • County(array)
          • id42
          • county_nameKisumu
          • created2012-06-15 10:27:02
          • modified2012-06-15 10:27:02
      • 1(array)
        • id1120
        • application_id1046
        • county_id45
        • site_nameKisii Teaching & Referral Hospital (KTRH)
        • physical_addressKisii Town
        • contact_detailsP.O. Box 92 - 40200 Kisii +254-58-31310
        • contact_personDr. Stanley Ratemo
        • site_capacity(null)
        • misc(null)
        • created2021-09-08 16:57:38
        • modified2021-10-13 00:59:49
        • County(array)
          • id45
          • county_nameKisii
          • created2012-06-15 10:27:25
          • modified2012-06-15 10:27:25
    • Sponsor(array)
      • 0(array)
        • id531
        • application_id1046
        • sponsorGrand Challenges Canada
        • sponsor_typeOthers
        • contact_personSonali Patel
        • addressMaRS Centre, West Tower Canada, 661 University Avenue, Suite 1720 Toronto ON M5G 1M1
        • telephone_number4166736568
        • fax_number
        • cell_number4166736568
        • email_addresssonali.patel@grandchallenges.ca
        • created2021-08-11 22:07:09
        • modified2021-10-13 00:59:49
  • 4(array)
    • Application(array)
      • id1044
      • user_id73
      • trial_status_id6
      • abstract_of_study<p>\n <span style=\"font-size:14px;\"><span style=\"font-family:arial,helvetica,sans-serif;\">Pre-exposure prophylaxis (PrEP) using co-formulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) is a potent HIV prevention method for men and cisgender women, with its efficacy highly dependent on adherence. Pivotal studies that combined clinical epidemiology and pharmacology defined thresholds for PrEP protection in men who have sex with men (MSM) that have been key to PrEP promotion and development of new PrEP agents. For African cisgender women at risk for HIV, a priority group due to disproportionately high incident HIV infections, variable adherence in PrEP clinical trials and limited pharmacologic data have resulted in lack of clarity about levels of PrEP use required for HIV protection. Single-dose tissue pharmacology studies suggest oral TDF/FTC PrEP dosing delivers 20- to 100-fold higher TFV-DP in rectal tissue compared with vaginal tissue, suggesting cisgender women may need extraordinary perfection for HIV protection; on the other hand, in clinical studies in cisgender women with reasonable-but-imperfect PrEP adherence, suggest important levels of HIV protection. Thus, understanding the pharmacological-HIV protection relationship for cisgender women is essential. We will conduct an open-label, randomized, three-arm, directly observed pharmacological study of TDF/FTC PrEP in African cisgender women. The primary objectives: 1) To define the cisgender women-specific expected blood concentrations and dose-proportionality for TFV-DP in DBS and PBMCs using directly observed TDF/FTC therapy at 2, 4, 7 doses per week. 2) To establish a model to predict adherence rate to TDF/FTC by level of TFV-DP in DBS for cisgender women. HIV-uninfected non-pregnant cisgender women will be randomly assigned to 1 of 3 dosing frequencies of directly observed therapy (DOT) TDF/FTC PrEP: 2, 4, or 7 doses/week to help differentiate poor and modest from perfect adherence. An additional contemporaneous cohort of pregnant cisgender women to receive daily dosing will also be recruited to evaluate the impact of pregnancy on blood and cellular drug levels. The study will enroll two cohorts of 18-30 years old HIV uninfected cisgender women at Thika site in Kenya: 1) Up to 54 non-pregnant cisgender women at low risk of HIV and 2) Up to 18 pregnant cisgender women at elevated risk of HIV and willing to use PrEP. The proposed study will be the first to define TDF-PrEP adherence-blood concentration thresholds for African cisgender women, a priority population for HIV prevention. The findings will guide accurate interpretation of adherence and success of PrEP programs in cisgender women. This data will also help guide decisions on optimal PrEP dosing for HIV at-risk pregnant cisgender women in Africa.</span></span></p>\n
      • study_title<p>\n <span style=\"font-size:14px;\"><span style=\"font-family:arial,helvetica,sans-serif;\">Pharmacology of TDF-FTC Pre-exposure Prophylaxis in Kenyan Cisgender Women</span></span></p>\n
      • laymans_summary<p>\n <span style=\"font-size:14px;\"><span style=\"font-family:arial,helvetica,sans-serif;\">African cisgender women are disproportionately affected with HIV and have an elevated risk of acquiring HIV in pregnancy. Pre-exposure prophylaxis (PrEP) is an effective HIV prevention strategy, but variable adherence in PrEP clinical trials among African cisgender women and limited pharmacologic data have resulted in lack of clarity about the degree of PrEP use required for HIV protection in cisgender women. For men who have sex with men, the STRAND study defined the adherence levels to PrEP medication and expected drug concentrations arising from varying directly observed therapy (DOT) doses per week. Those thresholds are today being applied to studies of African cisgender women taking PrEP, and cisgender women-specific levels associated with HIV prevention have never been defined. However, recent data from large PrEP studies we have done among African cisgender women ─including Partners PrEP Study and Partners Demonstration Projects conducted at Thika site─, suggest that these levels may not reflect the pharmacology of cisgender women in African settings, in general and particularly in pregnancy. In these studies in African populations, PrEP dosing was not directly observed therapy and no study has established expected PrEP concentrations in African cisgender women with varying frequency of PrEP adherence. Thus, there is an urgent need to define the frequency of adherence and expected blood concentrations of PrEP medications and their relationship to HIV protection in non-pregnant and pregnant cisgender women. </span></span></p>\n
      • short_titleWomen TDF/FTC Benchmark Study
      • protocol_noECCT/21/09/03
      • version_no1.0
      • date_of_protocol20-05-2021
      • study_drugBenchmark Study - TDF/FTC
      • disease_conditionHIV prevention
      • product_type_biologicals0
      • product_type_proteins0
      • product_type_immunologicals0
      • product_type_vaccines0
      • product_type_hormones0
      • product_type_toxoid0
      • product_type_chemical1
      • product_type_medical_device0
      • product_type_chemical_nameTD/FTC
      • product_type_medical_device_name
      • comparatorNo
      • comparator_name
      • comparator_registered
      • comparator_countries
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressregulatory@pipsthika.org
      • applicant_covering_letter1
      • applicant_protocol1
      • applicant_patient_information1
      • applicant_investigators_brochure1
      • applicant_investigators_cv1
      • applicant_signed_declaration1
      • applicant_financial_declaration1
      • applicant_gmp_certificate1
      • applicant_indemnity_cover1
      • applicant_opinion_letter1
      • applicant_approval_letter1
      • applicant_statement1
      • applicant_participating_countries(null)
      • applicant_addendum0
      • applicant_fees1
      • applicant_complete_form(null)
      • applicant_impd1
      • applicant_prev_data1
      • applicant_stability_data1
      • applicant_analysis_cert1
      • applicant_pictorial_sample1
      • applicant_gcp_training1
      • applicant_dsmb_charter1
      • applicant_detailed_budget1
      • applicant_indemnity_pi1
      • applicant_practice_license1
      • applicant_registration_ctr(null)
      • applicant_pan_african1
      • applicant_hard_copies(null)
      • applicant_signed_checklist1
      • statistical_analysis_plan1
      • applicant_contractual_agreement1
      • declaration_applicantPeter Mogere
      • declaration_date109-09-2021
      • declaration_principal_investigatorDr. Nelly Mugo
      • declaration_date209-09-2021
      • placebo_presentNo
      • study_objectives<p>\n <span style=\"font-size:14px;\"><span style=\"font-family:arial,helvetica,sans-serif;\"><strong>Primary objectives:</strong></span></span></p>\n<p>\n <span style=\"font-size:14px;\"><span style=\"font-family:arial,helvetica,sans-serif;\">1. To define the cisgender women-specific expected blood concentrations and dose-proportionality for TFV-DP in dried blood spots (DBS) and PBMCs using directly observed TDF/FTC therapy at 2, 4, 7 doses per week.</span></span></p>\n<p>\n <span style=\"font-size:14px;\"><span style=\"font-family:arial,helvetica,sans-serif;\">2. To establish a model to predict adherence rate to TDF/FTC by level of TFV-DP in DBS for cisgender women.</span></span></p>\n<p>\n <span style=\"font-size:14px;\"><span style=\"font-family:arial,helvetica,sans-serif;\"><strong>Secondary objectives:</strong></span></span></p>\n<p>\n <span style=\"font-size:14px;\"><span style=\"font-family:arial,helvetica,sans-serif;\">1. To define the expected concentrations and dose-proportionally for TFV-DP in PBMCs and vaginal tissue.</span></span></p>\n<p>\n <span style=\"font-size:14px;\"><span style=\"font-family:arial,helvetica,sans-serif;\">2. To quantify the effect of pregnancy on the benchmark concentrations of TFV, TFV-DP, FTC, and FTC-TP in pregnant cisgender women using daily DOT TDF/FTC </span></span></p>\n<p>\n <span style=\"font-size:14px;\"><span style=\"font-family:arial,helvetica,sans-serif;\">3. Examine relationships among drug concentrations in plasma, whole blood (WB), DBS, and PBMCs.</span></span></p>\n<p>\n <span style=\"font-size:14px;\"><span style=\"font-family:arial,helvetica,sans-serif;\">4. To determine the influence of biological variables (e.g. mean corpuscular volume and hematocrit, age, weight, sex) on drug concentrations.</span></span></p>\n<p>\n <span style=\"font-size:14px;\"><span style=\"font-family:arial,helvetica,sans-serif;\">5. Compare drug concentrations in DBS from fingerstick versus transferring blood from blood tubes.</span></span></p>\n
      • principal_inclusion_criteria<p>\n <span style=\"font-size:14px;\"><span style=\"font-family:arial,helvetica,sans-serif;\"><strong>Inclusion criteria for the pregnant cohort</strong></span></span></p>\n<ul>\n <li>\n <p>\n <span style=\"font-size:14px;\"><span style=\"font-family:arial,helvetica,sans-serif;\">Age ≥18 and ≤30 years</span></span></p>\n </li>\n <li>\n <p>\n <span style=\"font-size:14px;\"><span style=\"font-family:arial,helvetica,sans-serif;\">HIV uninfected</span></span></p>\n </li>\n <li>\n <p>\n <span style=\"font-size:14px;\"><span style=\"font-family:arial,helvetica,sans-serif;\">Has an active smart phone</span></span></p>\n </li>\n <li>\n <p>\n <span style=\"font-size:14px;\"><span style=\"font-family:arial,helvetica,sans-serif;\">Normal renal function (GFR >60ml/min)</span></span></p>\n </li>\n <li>\n <p>\n <span style=\"font-size:14px;\"><span style=\"font-family:arial,helvetica,sans-serif;\">Hepatitis B surface Ag negative</span></span></p>\n </li>\n <li>\n <p>\n <span style=\"font-size:14px;\"><span style=\"font-family:arial,helvetica,sans-serif;\">High risk for HIV</span></span></p>\n </li>\n <li>\n <p>\n <span style=\"font-size:14px;\"><span style=\"font-family:arial,helvetica,sans-serif;\">Pregnant at 13-26 weeks of gestation</span></span></p>\n </li>\n <li>\n <p>\n <span style=\"font-size:14px;\"><span style=\"font-family:arial,helvetica,sans-serif;\">Willing to use DOT and come to clinic daily for DOT PrEP for 8 weeks</span></span></p>\n </li>\n <li>\n <p>\n <span style=\"font-size:14px;\"><span style=\"font-family:arial,helvetica,sans-serif;\">Willing to have home visits/video streaming if clinic visit not feasible</span></span></p>\n </li>\n</ul>\n<p>\n <span style=\"font-size:14px;\"><span style=\"font-family:arial,helvetica,sans-serif;\"><strong>Inclusion criteria for the non- pregnant cohort</strong></span></span></p>\n<ul>\n <li>\n <span style=\"font-size:14px;\"><span style=\"font-family:arial,helvetica,sans-serif;\">Age ≥18 and ≤30 years</span></span></li>\n <li>\n <span style=\"font-size:14px;\"><span style=\"font-family:arial,helvetica,sans-serif;\">HIV uninfected</span></span></li>\n <li>\n <span style=\"font-size:14px;\"><span style=\"font-family:arial,helvetica,sans-serif;\">Has an active smart phone</span></span></li>\n <li>\n <span style=\"font-size:14px;\"><span style=\"font-family:arial,helvetica,sans-serif;\">Normal renal function (GFR >60ml/min)</span></span></li>\n <li>\n <span style=\"font-size:14px;\"><span style=\"font-family:arial,helvetica,sans-serif;\">Hepatitis B surface Ag negative</span></span></li>\n <li>\n <span style=\"font-size:14px;\"><span style=\"font-family:arial,helvetica,sans-serif;\">Low risk for HIV</span></span></li>\n <li>\n <span style=\"font-size:14px;\"><span style=\"font-family:arial,helvetica,sans-serif;\">Not pregnant or breastfeeding</span></span></li>\n <li>\n <span style=\"font-size:14px;\"><span style=\"font-family:arial,helvetica,sans-serif;\">Willing to be randomized to non-daily PrEP and come to clinic frequently for DOT PrEP</span></span></li>\n <li>\n <span style=\"font-size:14px;\"><span style=\"font-family:arial,helvetica,sans-serif;\"><span style=\"font-size: 14px;\"><span style=\"font-family: arial, helvetica, sans-serif;\">Willing to have home visits/video streaming if clinic visit not feasible</span></span></span></span></li>\n</ul>\n<p>\n  </p>\n
      • principal_exclusion_criteria<p>\n <span style=\"font-size:14px;\"><span style=\"font-family:arial,helvetica,sans-serif;\"><strong>Exclusion criteria for pregnant women</strong></span></span></p>\n<ul>\n <li>\n <span style=\"font-size:14px;\"><span style=\"font-family:arial,helvetica,sans-serif;\">Inability to give informed consent</span></span></li>\n <li>\n <span style=\"font-size:14px;\"><span style=\"font-family:arial,helvetica,sans-serif;\">HIV positive test at screening or suspected acute HIV infection in the opinion of the clinician</span></span></li>\n <li>\n <span style=\"font-size:14px;\"><span style=\"font-family:arial,helvetica,sans-serif;\">Concomitant medications taken within 30 days of enrollment: aminoglycosides, ganciclovir/valganciclovir, chronic high-dose acyclovir/valacyclovir (>800mg acyclovir or > 500mg valacyclovir for >7 days), cyclosporine, amphotericin B, foscarnet, and cidofovir, and products with same or similar active ingredients as the study medications including TAF®, ATRIPLA®, COMPLERA®, EMTRIVA®, VIREAD®; or drugs containing lamivudine or adefovir, which are close analogs of FTC and tenofovir, respectively.</span></span></li>\n <li>\n <span style=\"font-size:14px;\"><span style=\"font-family:arial,helvetica,sans-serif;\">Current or past use of PrEP (pre-exposure prophylaxis)</span></span></li>\n <li>\n <span style=\"font-size:14px;\"><span style=\"font-family:arial,helvetica,sans-serif;\">Not willing to have home visit</span></span></li>\n <li>\n <span style=\"font-size:14px;\"><span style=\"font-family:arial,helvetica,sans-serif;\">Sickle cell anemia, chronic bleeding, blood transfusion within the past 120 days (excluding for chronic illness) or other blood dyscrasias</span></span></li>\n <li>\n <span style=\"font-size:14px;\"><span style=\"font-family:arial,helvetica,sans-serif;\">Fetus has a known or suspected major congenital anomaly defined by fetal ultrasound. </span></span></li>\n</ul>\n<p>\n <span style=\"font-size:14px;\"><span style=\"font-family:arial,helvetica,sans-serif;\"><strong>Exclusion criteria for non-pregnant women</strong></span></span></p>\n<ul>\n <li>\n <span style=\"font-size:14px;\"><span style=\"font-family:arial,helvetica,sans-serif;\">Inability to give informed consent</span></span></li>\n <li>\n <span style=\"font-size:14px;\"><span style=\"font-family:arial,helvetica,sans-serif;\">HIV positive test at screening or suspected acute HIV infection in the opinion of the clinician</span></span></li>\n <li>\n <span style=\"font-size:14px;\"><span style=\"font-family:arial,helvetica,sans-serif;\">Concomitant medications taken within 30 days of enrollment: aminoglycosides, ganciclovir/valganciclovir, chronic high-dose acyclovir/valacyclovir (>800mg acyclovir or > 500mg valacyclovir for >7 days), cyclosporine, amphotericin B, foscarnet, and cidofovir, and products with same or similar active ingredients as the study medications including TAF®, ATRIPLA®, COMPLERA®, EMTRIVA®, VIREAD®; or drugs containing lamivudine or adefovir, which are close analogs of FTC and tenofovir, respectively.</span></span></li>\n <li>\n <span style=\"font-size:14px;\"><span style=\"font-family:arial,helvetica,sans-serif;\">Current or past use of PrEP (pre-exposure prophylaxis)</span></span></li>\n <li>\n <span style=\"font-size:14px;\"><span style=\"font-family:arial,helvetica,sans-serif;\">pregnancy/plan to become pregnant in the next 6 months/unwillingness to use birth control</span></span></li>\n</ul>\n
      • primary_end_points<ul>\n <li>\n <span style=\"font-size:14px;\"><span style=\"font-family:arial,helvetica,sans-serif;\">Define benchmark concentrations of TFV-DP in DBS and PBMCs, and the dosing frequency (i.e., doses per week) required to generate them.  </span></span></li>\n <li>\n <span style=\"font-size:14px;\"><span style=\"font-family:arial,helvetica,sans-serif;\">Define how pregnancy affects the expected blood levels to help define optimal dosing of PrEP for HIV prevention during pregnancy.</span></span></li>\n</ul>\n
      • scope_diagnosis0
      • scope_prophylaxis1
      • scope_therapy0
      • scope_safety0
      • scope_efficacy0
      • scope_pharmacokinetic1
      • scope_pharmacodynamic0
      • scope_bioequivalence0
      • scope_dose_response0
      • scope_pharmacogenetic0
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic0
      • scope_others0
      • scope_others_specify
      • trial_human_pharmacology0
      • trial_administration_humans0
      • trial_bioequivalence_study0
      • trial_other0
      • trial_other_specify
      • trial_therapeutic_exploratory1
      • trial_therapeutic_confirmatory0
      • trial_therapeutic_use0
      • design_controlledNo
      • site_capacity(null)
      • staff_numbers<p font-size:=\"\" line-height:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n KEMRI-CCR Partners in Health & Research Development - PHRD (Formerly Partners in Prevention) Thika Project, has 64 full time clinical trial staff (including physicians, nurses, counsellors, pharmacist, pharmaceutical technologists, clinical officers, social scientists, administrative staff etc).</p>\n<p font-size:=\"\" line-height:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n Principal Investigator: Dr. Nelly R. Mugo  MBChB,MMED,MPH</p>\n<p font-size:=\"\" line-height:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n Site Principal Investigator: Dr. Kenneth Ngure  BSc,MPH,MSc,PhD</p>\n<p font-size:=\"\" line-height:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n                                         Dr. Elizabeth Irungu MBChB, MPH, PHD</p>\n<p font-size:=\"\" line-height:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n Site Coordinator: Dr. Catherine Kiptinness, BPharm, MPH</p>\n<p font-size:=\"\" line-height:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n Regulatory Lead: Peter Mogere, DPharm., B.Sc</p>\n
      • other_details_explanation<div style=\"margin-left:.25in;\">\n <span style=\"font-size:14px;\"><span style=\"font-family:arial,helvetica,sans-serif;\">Adolescent girls and young women (AGYW) are only 10% of sub-Saharan population yet they account for 24% of new HIV infections¹. In Kenya, AGYW(10-24 years) have a 2.2-fold higher incidence of HIV than their male counterparts and represent 1/3 of all annual new infections^2-3.Pre-exposure prophylaxis (PrEP) is an effective and recommended strategy for HIV prevention and only works when taken as recommended. TDF/FTC as PrEP is the currently approved combination drug product for women. Recent clinical studies in African cisgender women with reasonable but imperfect PrEP adherence, there is evidence to suggest important levels of HIV protection. I</span></span><span style=\"font-family: arial, helvetica, sans-serif; font-size: 14px;\">n pregnancy TFV-DP levels are even lower. </span><span style=\"font-family: arial, helvetica, sans-serif; font-size: 14px;\">Previous studies have defined adherence concentration thresholds among MSMs. Women may require higher adherence levels for similar PrEP efficacy than MSM because of lower active drug concentrations in genital versus rectal tissues.  There is lack of data on minimum dose required to confer protection against HIV in women from the previous trials. </span><span style=\"font-family: arial, helvetica, sans-serif; font-size: 14px;\">Thus, there is an urgent need to define the frequency of adherence and expected blood concentrations of PrEP medications and their relationship to HIV protection in non-pregnant and pregnant cisgender women. The trial seeks to fill this gap using TDF-FTC daily observed therapy (DOT) in women.</span></div>\n<div style=\"margin-left:.25in;\">\n <table border=\"1\" cellpadding=\"1\" cellspacing=\"1\" style=\"width:500px;\">\n <tbody>\n <tr>\n <td>\n <p style=\"color: rgb(32, 31, 30); font-size: 12pt; font-family: Calibri, sans-serif; margin: 0px;\">\n <span style=\"margin: 0px; padding: 0px; border: 0px; font-style: inherit; font-variant: inherit; font-weight: inherit; font-stretch: inherit; font-size: 11pt; line-height: inherit; font-family: Arial, sans-serif; vertical-align: baseline; color: inherit;\">1. <span style=\"font-size:10px;\">UNAIDS, 2020</span></span></p>\n <p style=\"color: rgb(32, 31, 30); font-size: 12pt; font-family: Calibri, sans-serif; margin: 0px;\">\n <span style=\"font-size:10px;\"><span style=\"margin: 0px; padding: 0px; border: 0px; font-style: inherit; font-variant: inherit; font-weight: inherit; font-stretch: inherit; line-height: inherit; font-family: Arial, sans-serif; vertical-align: baseline; color: inherit;\">2. UNAIDS. AIDSInfo-Kenya [Internet]. Available from: https://aidsinfo.unaids.org</span></span></p>\n <p style=\"color: rgb(32, 31, 30); font-size: 12pt; font-family: Calibri, sans-serif; margin: 0px;\">\n <span style=\"font-size:10px;\"><span style=\"margin: 0px; padding: 0px; border: 0px; font-style: inherit; font-variant: inherit; font-weight: inherit; font-stretch: inherit; line-height: inherit; font-family: Arial, sans-serif; vertical-align: baseline; color: inherit;\">3. Kenya Population-based HIV Impact Assessment (KENPHIA) Preliminary Report 2018 [Internet]. Kenya Ministry of Health, National AIDS and STI Control Program; Available from: https://www.nascop.or.ke/kenphia-report/</span></span></p>\n </td>\n </tr>\n </tbody>\n </table>\n <p>\n  </p>\n</div>\n<p>\n  </p>\n
      • other_details_regulatory_notapproved<p>\n <span style=\"font-size:14px;\"><span style=\"font-family:arial,helvetica,sans-serif;\">University of Washington IRB</span></span></p>\n
      • other_details_regulatory_approved<p>\n <span style=\"font-size:14px;\"><span style=\"font-family:arial,helvetica,sans-serif;\">Kenya Medical Research Institute</span></span></p>\n<p>\n <span style=\"font-size:14px;\"><span style=\"font-family:arial,helvetica,sans-serif;\">Approval date: 22/07/2021</span></span></p>\n
      • other_details_regulatory_rejected<p>\n <span style=\"font-size:14px;\"><span style=\"font-family:arial,helvetica,sans-serif;\">None</span></span></p>\n
      • other_details_regulatory_halted<p>\n <span style=\"font-size:14px;\"><span style=\"font-family:arial,helvetica,sans-serif;\">N/A</span></span></p>\n
      • estimated_duration2 years
      • design_controlled_randomised
      • design_controlled_open
      • design_controlled_single_blind
      • design_controlled_double_blind
      • design_controlled_parallel_group
      • design_controlled_cross_over
      • design_controlled_other
      • design_controlled_specify
      • design_controlled_comparator
      • design_controlled_other_medicinal
      • design_controlled_placebo
      • design_controlled_medicinal_other
      • design_controlled_medicinal_specify
      • single_site_member_stateYes
      • location_of_areaKEMRI-CCR PHRD (THIKA) PROJECT
      • single_site_physical_addressThika Section 9, OAU Road, Near Thika Nursing Home
      • single_site_contact_personDr. Kenneth Ngure
      • single_site_telephone+254 722362219
      • multiple_sites_member_stateNo
      • multiple_countriesNo
      • multiple_member_states
      • number_of_sites
      • multi_country_list
      • data_monitoring_committeeNo
      • total_enrolment_per_site72
      • total_participants_worldwide72
      • population_less_than_18_yearsNo
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerNo
      • population_childrenNo
      • population_adolescentNo
      • population_above_18Yes
      • population_adultYes
      • population_elderlyNo
      • gender_female1
      • gender_male0
      • subjects_healthyYes
      • subjects_patientsNo
      • subjects_vulnerable_populationsYes
      • subjects_women_child_bearingYes
      • subjects_women_using_contraceptionYes
      • subjects_pregnant_womenYes
      • subjects_nursing_womenNo
      • subjects_emergency_situationNo
      • subjects_incapable_consentNo
      • subjects_specify
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameKenneth
      • investigator1_middle_name
      • investigator1_family_nameMugwanya
      • investigator1_qualificationMBChB, MS,PhD
      • investigator1_professional_addressUniversity of Washington 325 Ninth Avenue; Box 359927 Seattle, WA 98104, USA
      • investigator1_telephone206-520-3886
      • investigator1_emailmugwanya@uw.edu
      • organisations_transferred_Yes
      • number_participants72
      • notification
      • approval_date19-12-2021
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted08-10-2021
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reasonThe application has been approved by the experts
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      • quantity_destroyed(null)
      • quantity_exported(null)
      • balance_site(null)
      • final_date(null)
      • modified2023-11-09 10:48:19
      • created2021-08-06 08:51:36
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id706
        • application_id1044
        • given_nameNelly
        • middle_name
        • family_nameMugo
        • qualificationMBChB, MMeD, MPH
        • professional_addressKEMRI-CCR
        • telephone+254722823770
        • emailrwamba@uw.edu
        • created2021-08-06 10:49:52
        • modified2021-10-08 09:25:57
    • SiteDetail(array)
      • 0(array)
        • id1089
        • application_id1044
        • county_id(null)
        • site_name
        • physical_address
        • contact_details
        • contact_person
        • site_capacity(null)
        • misc(null)
        • created2021-08-06 10:49:52
        • modified2021-10-08 09:25:57
        • County(empty)
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      • 0(array)
        • id529
        • application_id1044
        • sponsorUniversity of Washington
        • sponsor_typeResearch Institution
        • contact_personDr. Nelly Mugo
        • addressKEMRI-CCR
        • telephone_number+254 722823770
        • fax_number
        • cell_number+254 722823770
        • email_addressrwamba@uw.edu
        • created2021-08-06 10:49:52
        • modified2021-10-08 09:25:57
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• plugins(array)
  • CakePdf(array)
    • Config(array)
      • 0CakePdf/Config/bootstrap.php
      • 1CakePdf/Config/routes.php
  • CakeResque(array)
    • Config(array)
      • 0CakeResque/Config/bootstrap.php
    • Plugin(array)
      • 0CakeResque/Lib/CakeResque.php
      • 1CakeResque/vendor/kamisama/php-resque-ex/lib/Resque.php
      • 2CakeResque/vendor/kamisama/php-resque-ex/lib/Resque/Event.php
      • 3CakeResque/vendor/kamisama/php-resque-ex/lib/Resque/Exception.php
  • DebugKit(array)
    • Component(array)
      • 0DebugKit/Controller/Component/ToolbarComponent.php
    • Plugin(array)
      • 0DebugKit/Lib/DebugMemory.php
      • 1DebugKit/Lib/Panel/HistoryPanel.php
      • 2DebugKit/Lib/DebugPanel.php
      • 3DebugKit/Lib/Panel/SessionPanel.php
      • 4DebugKit/Lib/Panel/RequestPanel.php
      • 5DebugKit/Lib/Panel/SqlLogPanel.php
      • 6DebugKit/Lib/Panel/TimerPanel.php
      • 7DebugKit/Lib/Panel/LogPanel.php
      • 8DebugKit/Lib/Log/Engine/DebugKitLog.php
      • 9DebugKit/Lib/Panel/VariablesPanel.php
      • 10DebugKit/Lib/Panel/EnvironmentPanel.php
      • 11DebugKit/Lib/Panel/IncludePanel.php
      • 12DebugKit/Lib/DebugTimer.php
  • Media(array)
    • Config(array)
      • 0Media/Config/bootstrap.php
    • Plugin(array)
      • 0Media/Lib/mm/src/Mime/Type.php
      • 1Media/Lib/mm/src/Mime/Type/Magic/Adapter/Fileinfo.php
      • 2Media/Lib/mm/src/Mime/Type/Magic/Adapter.php
      • 3Media/Lib/mm/src/Mime/Type/Glob/Adapter/Memory.php
      • 4Media/Lib/mm/src/Mime/Type/Glob/Adapter.php
      • 5Media/Lib/mm/src/Media/Process.php
      • 6Media/Lib/mm/src/Media/Info.php
  • Search(array)
    • Component(array)
      • 0Search/Controller/Component/PrgComponent.php
    • Behavior(array)
      • 0Search/Model/Behavior/SearchableBehavior.php
  • Shim(array)
    • Config(array)
      • 0Shim/Config/bootstrap.php
  • Tools(array)
    • Config(array)
      • 0Tools/Config/bootstrap.php