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  • 1Recruiting
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• applications(array)
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    • Application(array)
      • id1002
      • user_id688
      • trial_status_id(null)
      • abstract_of_study<p>\n <strong>Background</strong></p>\n<p>\n Attention deficit hyperactivity disorder (ADHD) is the most common neuropsychiatric disorder in children. Treatment includes behavior therapy with or without pharmacotherapy, with the former being less efficacious. Pharmacotherapy is associated with about 0.54 effect size on hyperactivity indices as reported by parents, with similar efficacy in both long acting and short acting forms, and is not necessarily a panacea for all the symptoms of ADHD. It is also associated with serious adverse events, occurring in 1.2% of participants in a Cochrane review of randomized control trials, while more than half of the participants suffered one or more adverse events.</p>\n<p>\n Interventional trials done on the use of broad spectrum micronutrients (multivitamins, minerals and polyunsaturated fatty acids) have demonstrated improvement in ADHD symptoms in children, with two trials showing improvements in one third of children with inattentive symptoms.</p>\n<p>\n <strong>Justification</strong></p>\n<p>\n Malnutrition with multiple micronutrient deficiencies is common and may impact the symptomatology of ADHD in our setting.</p>\n<p>\n Micronutrients present a safe and scalable treatment option. Despite showing promising evidence as a treatment modality for ADHD, only a handful of studies have been done on their use.</p>\n<p>\n <strong>Objectives</strong></p>\n<p>\n The primary objective is to evaluate the efficacy of broad spectrum micronutrients on hyperactivity and inattentive symptoms on patients 6 to 13 years of age with ADHD who do not qualify to be on pharmacotherapy over 12 weeks’ duration.</p>\n<p>\n <strong>Method</strong></p>\n<p>\n The study is an open-label randomized controlled trial. Patients on behavior therapy meeting inclusion criteria will be recruited from Kenyatta National hospital child psychiatry clinic and randomized into two arms: broad spectrum micronutrients and no micronutrient therapy. The intervention will be Centrum Kids Chewables Multivitamin/ Multimineral supplement and Sundown omega 3 gel. Related clinical data will be collected using a structured questionnaire, and outcomes assessed using the Conner’s Parent Rating Scale-Revised Long Form and the Clinical Global Impression Scales. Continuous and discrete variables will be analyzed using appropriate parametric and non-parametric tests.</p>\n
      • study_title<p>\n Broad spectrum micronutrient supplementation in the management of ADHD symptoms:a clinical trial</p>\n
      • laymans_summary<p>\n Attention deficit hyperactivity disorder (ADHD) is the most common neuropsychiatric disorder in children. Treatment includes use of behavior therapy, which is use of methods to strengthen positive behavior and eliminate negative behavior,  with or without the use of medication. Medication works more effectively compared to behavior therapy but it it associated with harmful, unwanted effects in more than half of those who use it. Use of multivitamins, minerals  and omega 3 have been shown to individually show improvements in symptoms of ADHD. </p>\n<div>\n This paper aims to investigate how effective broad spectrum micronutrients (multivitamins, minerals and omega 3) are in management of inattentiveness and hyperactivity in patients who are 6 to 13 years of age with ADHD, and who do not qualify to be on pharmacotherapy, over 12 weeks duration</div>\n
      • short_titleMulti-nutrients in ADHD
      • protocol_noECCT/21/05/04
      • version_no1
      • date_of_protocol18-05-2021
      • study_drugCentrum Kids Chewables Multivitamin/Multimineral supplement and Sundown omega 3 gel
      • disease_conditionAttention Deficit Hyperactivity Disorder
      • 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_nameMultivitamins, minerals and polyunsaturated fatty acids
      • product_type_medical_device_name
      • comparatorNo
      • comparator_name
      • comparator_registered
      • comparator_countries
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressdrmuthoninjoroge@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
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      • applicant_prev_data1
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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
      • applicant_hard_copies(null)
      • applicant_signed_checklist1
      • statistical_analysis_plan1
      • applicant_contractual_agreement1
      • declaration_applicantDr. Maureen Njoroge
      • declaration_date118-05-2021
      • declaration_principal_investigatorDr. Maureen Njoroge
      • declaration_date218-05-2021
      • placebo_presentNo
      • study_objectives<p>\n To evaluate the effect of broad spectrum micronutrients on hyperactivity and inattentive symptoms on patients 6 to 13 years of age with ADHD over 12 weeks’ duration.</p>\n
      • principal_inclusion_criteria<p>\n 1. Children 6 to 13 years of age with a diagnosis of ADHD made by a child psychiatrist using the DSM-5 criteria</p>\n<p>\n 2. Patients who are not on pharmacotherapy having been initiated on behavioral therapy as a first step in care or patients who have previously been on pharmacotherapy but have since stopped use, at least one month before consideration for recruitment, because of insufficient response or intolerance to side effects.</p>\n<p>\n 3. Informed written consent to participate in the study</p>\n
      • principal_exclusion_criteria<p>\n 1. Patients on pharmacotherapy</p>\n<p>\n 2. Patients already on multivitamin/ PUFA supplementation</p>\n<p>\n 3. Patients with co-existing Autism Spectrum Disorder (ASD) and/or Epilepsy</p>\n
      • primary_end_points<p>\n Hyperactivity and inattentive symptom score at 12 weeks using the Conner's Parent Rating Scale Revised Long Form and the Clinical Global Impression scale</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_exploratory0
      • trial_therapeutic_confirmatory0
      • trial_therapeutic_use1
      • design_controlledYes
      • site_capacity(null)
      • staff_numbers<p>\n The study will be carried out in the child psychiatry clinic at KNH. This clinic sees about fifteen patients with ADHD a month and is the largest of its kind in a public hospital setting. It is run by two child psychiatrists once a week, one of whom is involved in the study.</p>\n<p>\n KNH is also a teaching hospital, whereby psychiatrists are trained. The patients recruited will be those that have been diagnosed by a child psychiatrist to have ADHD. The availability of another child psychiatrist and other psychiatrists rotating with a keen interest in child psychiatry allows us to get an independent assessor not involved in the study, hence impartial, and who is conversant with ADHD in children.</p>\n<p>\n The clinic also has records personnel who keep logs of all patients who attend the clinic and have access to the patient’s files. This enables us to access and sample the files consecutively so as to get those that meet the inclusion criteria.</p>\n<p>\n The clinic has a waiting area where the patients can sit and wait to be triaged. This area has a television for children’s entertainment hence keeps the patients occupied as they await to be seen. The triage area has a weighing scale and a standing frame to measure height which will be used to get the patient’s weight and height. Triage of patients is performed by a nurse who is allocated to the clinic.</p>\n<p>\n Consultation rooms are available for review of the patients. Four rooms are available on clinic days, two of which are used by the child psychiatrists and one will be used for recruitment of patients into the study while the other one will be for administration of the questionnaire, the Clinical Global Impression Scale (CGI) and the Conner's Parent Rating Scale Revised Long Form (CPRS:R-L).</p>\n
      • other_details_explanation<p>\n N/A</p>\n
      • other_details_regulatory_notapproved<p>\n N/A</p>\n
      • other_details_regulatory_approved<p>\n N/A</p>\n
      • other_details_regulatory_rejected<p>\n N/A</p>\n
      • other_details_regulatory_halted<p>\n N/A</p>\n
      • estimated_duration12 weeks
      • design_controlled_randomisedYes
      • design_controlled_openYes
      • design_controlled_single_blindNo
      • design_controlled_double_blindNo
      • design_controlled_parallel_groupNo
      • design_controlled_cross_overNo
      • design_controlled_otherNo
      • design_controlled_specify
      • design_controlled_comparatorNo intervention
      • design_controlled_other_medicinalNo
      • design_controlled_placeboNo
      • design_controlled_medicinal_otherNo
      • design_controlled_medicinal_specify
      • single_site_member_stateYes
      • location_of_areaKenyatta National Hospital
      • single_site_physical_addressP.O . Box 20723-00202
      • single_site_contact_personDr. Josephine Omondi
      • single_site_telephone0720474609
      • multiple_sites_member_stateNo
      • multiple_countriesNo
      • multiple_member_states
      • number_of_sites
      • multi_country_list
      • data_monitoring_committeeNo
      • total_enrolment_per_site30
      • total_participants_worldwide30
      • population_less_than_18_yearsYes
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerNo
      • population_childrenYes
      • population_adolescentNo
      • population_above_18No
      • population_adultNo
      • population_elderlyNo
      • gender_female1
      • gender_male1
      • subjects_healthyYes
      • subjects_patientsNo
      • subjects_vulnerable_populationsNo
      • subjects_women_child_bearingNo
      • subjects_women_using_contraceptionNo
      • subjects_pregnant_womenNo
      • subjects_nursing_womenNo
      • subjects_emergency_situationNo
      • subjects_incapable_consentNo
      • subjects_specify
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameMaureen
      • investigator1_middle_name
      • investigator1_family_nameNjoroge
      • investigator1_qualificationMBChB, MMed Paediatrics and Child Health
      • investigator1_professional_addressAga Khan University, P.0. Box 30270-00100 Nairobi
      • investigator1_telephone0723448424
      • investigator1_emaildrmuthoninjoroge@gmail.com
      • organisations_transferred_No
      • number_participants30
      • notification
      • approval_date10-11-2021
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted31-05-2021
      • is_child0
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reasonThe application has been approved by the experts
      • final_report(null)
      • implication_results(null)
      • quantity_imported(null)
      • quantity_dispensed(null)
      • quantity_destroyed(null)
      • quantity_exported(null)
      • balance_site(null)
      • final_date(null)
      • modified2021-11-10 06:33:28
      • created2021-05-18 06:05:18
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
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        • id648
        • application_id1002
        • given_nameMaureen
        • middle_nameMuthoni
        • family_nameNjoroge
        • qualificationMBChB, MMed Paediatrics and Child Health
        • professional_addressAga Khan University, P.0. Box 30270-00100 Nairobi
        • telephone0723448424
        • emaildrmuthoninjoroge@gmail.com
        • created2021-05-18 07:13:27
        • modified2021-05-31 15:08:47
    • SiteDetail(array)
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        • id897
        • application_id1002
        • county_id(null)
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        • contact_details
        • contact_person
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        • misc(null)
        • created2021-05-18 07:13:27
        • modified2021-05-31 15:08:47
        • County(empty)
    • Sponsor(array)
      • 0(array)
        • id497
        • application_id1002
        • sponsorMaureen Njoroge
        • sponsor_typeOthers
        • contact_personSelf sponsorship
        • address35315
        • telephone_number0723448424
        • fax_number
        • cell_number0723448424
        • email_addressdrmuthoninjoroge@gmail.com
        • created2021-05-18 07:13:27
        • modified2021-05-31 15:08:47
  • 1(array)
    • Application(array)
      • id694
      • user_id408
      • trial_status_id(null)
      • abstract_of_study<p>\n <strong>Background: </strong>According to WHO, Vitamin A is one of the essential micronutrient whose deficiency affects approximately one third of children under five years around the world. About 40,000 children die annually due to underweight and vitamin A deficiency in Kenya.  Nationally Vitamin A coverage is 40% with deficiency being ranked 7^th mortality risk factor (5^th in Busia) and an all spectrum prevalence of 61.8% in preschool children. Studies have recommended high-dose supplementation and zinc administration to deficient populations.</p>\n<p>\n  </p>\n<p>\n <strong>Objective:</strong> The main objective of this study is to determine the efficacy of a stepped up Vitamin A supplementation dose to infants (6-12 months) in Busia County in Kenya.</p>\n<p>\n  </p>\n<p>\n <strong>Materials and methods</strong>: Mixed methods design will address the efficacy of different doses of Vitamin A and challenges associated with it’s supplementation. Under quantitative, biochemical analysis sheets, check lists and mother child health records will be used to test the theory of improved immunity with a higher dose, which predicts that a stepped up Vitamin A dose (200,000 IU) as compared to standard dose (100,000 IU) will influence retinol levels and immuno-biomakers positively hence reduced morbidity episodes for 120 infants (6-12 months) at Busia Level 4 Hospital, Busia County.  Qualitative data using key informant interviews and focus group discussions will explore the challenges of Vitamin A supplementation for 72 mothers, 4 County Health Management Team (4) and 6 staff. The mixed methods design will bring together the strengths of both methods to triangulate and corroborate results. Quantitative and qualitative data will be analyzed using descriptive statistics and thematic framework respectively. The proposal will be submitted to Scientific and Ethical Review Unit at KEMRI for approval. The results will benefit the Ministry of Health with policy briefs, programme implementers with improved intervention strategies, scientists with new knowledge and mothers/infants with improved child survival outcomes. </p>\n
      • study_title<p>\n BUSIA LEVEL IV HOSPITAL</p>\n
      • laymans_summary(null)
      • short_titleRANDOMIZED CONTROLLED TRIAL OF STEPPED UP VITAMIN A SUPPLEMENTATION DOSE ON IMMUNE RESPONSES AMONG INFANTS 6-12 MONTHS AT BUSIA LEVEL 4 HOSPITAL IN BUSIA COUNTY, KENYA
      • protocol_noECCT/18/06/04
      • version_no1
      • date_of_protocol01-01-1970
      • study_drugVitamin A
      • disease_conditionVitamin A Deficiency (VAD)
      • product_type_biologicals1
      • product_type_proteins0
      • product_type_immunologicals0
      • product_type_vaccines0
      • product_type_hormones1
      • product_type_toxoid0
      • product_type_chemical0
      • product_type_medical_device0
      • product_type_chemical_nameRetinol Palmitate
      • product_type_medical_device_name
      • comparator(null)
      • comparator_name(null)
      • comparator_registered(null)
      • comparator_countries(null)
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressbenard.wesonga@mmust.ac.ke
      • 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_letter0
      • applicant_statement1
      • applicant_participating_countries0
      • applicant_addendum0
      • applicant_fees1
      • applicant_complete_form(null)
      • applicant_impd(null)
      • applicant_prev_data(null)
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      • applicant_pictorial_sample(null)
      • applicant_gcp_training(null)
      • applicant_dsmb_charter(null)
      • applicant_detailed_budget(null)
      • applicant_indemnity_pi(null)
      • applicant_practice_license(null)
      • applicant_registration_ctr(null)
      • applicant_pan_african(null)
      • applicant_hard_copies(null)
      • applicant_signed_checklist(null)
      • statistical_analysis_plan(null)
      • applicant_contractual_agreement(null)
      • declaration_applicantDr Benard Wesonga
      • declaration_date111-06-2018
      • declaration_principal_investigatornational Principal Investigator
      • declaration_date211-06-2018
      • placebo_presentNo
      • study_objectives(null)
      • principal_inclusion_criteria<p style=\"margin-left:.5in;\">\n   Infants 6-12 months of age</p>\n<p style=\"margin-left:.5in;\">\n  Infants whose mothers give written consent</p>\n<p>\n                Those who meet protocol requirements</p>\n
      • principal_exclusion_criteria<ul>\n <li>\n Infants below 6 and above 12 months</li>\n <li>\n Children with confirmed immunological disorders.</li>\n <li>\n Children on Vitamin A/zinc treatment or supplementation</li>\n <li>\n Those whose parents refuse to give consent.</li>\n <li>\n Children with known allergic reactions to Vitamin A.</li>\n <li>\n Children on treatment with another investigational drug or other intervention</li>\n</ul>\n
      • primary_end_points<ul>\n <li>\n Frequency of occurrence of fever and diarrhea in infants in both control and treatment groups</li>\n <li>\n CD<strong>₄</strong> Counts</li>\n</ul>\n
      • scope_diagnosis0
      • scope_prophylaxis0
      • scope_therapy0
      • scope_safety0
      • 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 Doctors (2)</p>\n<p>\n Clinical officers (4)</p>\n<p>\n Nurses  (10)</p>\n<p>\n Nutritionists (2)</p>\n<p>\n Lab technitians (3)</p>\n
      • other_details_explanation
      • other_details_regulatory_notapproved<p>\n None</p>\n
      • other_details_regulatory_approved<p>\n Scientific and Ethical Review Unit (KEMRI) 12/9/2017</p>\n
      • other_details_regulatory_rejected<p>\n None</p>\n
      • other_details_regulatory_halted<p>\n None</p>\n
      • estimated_durationSix (6) Months
      • design_controlled_randomisedYes
      • design_controlled_openNo
      • design_controlled_single_blindYes
      • design_controlled_double_blindNo
      • design_controlled_parallel_groupYes
      • design_controlled_cross_overNo
      • design_controlled_otherNo
      • design_controlled_specify
      • design_controlled_comparatorVitamin A 200,000 IU
      • design_controlled_other_medicinalNo
      • design_controlled_placeboNo
      • design_controlled_medicinal_otherNo
      • design_controlled_medicinal_specify
      • single_site_member_stateYes
      • location_of_areaBusia Level IV Hospital
      • single_site_physical_addressBusia County off Busia Kisumu Road
      • single_site_contact_personDirector of Health Services, Dr Melisa Lutomia
      • single_site_telephone0722434282
      • multiple_sites_member_stateNo
      • multiple_countriesNo
      • multiple_member_states
      • number_of_sites
      • multi_country_list
      • data_monitoring_committeeNo
      • total_enrolment_per_site120
      • total_participants_worldwide120
      • population_less_than_18_yearsYes
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerYes
      • population_childrenNo
      • 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_specifyinfants 6 months to 12 months
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameAnselimo
      • investigator1_middle_name
      • investigator1_family_nameMakokha
      • investigator1_qualificationPhD in nutrition
      • investigator1_professional_addressP.O. Box 62000-00200 Nairobi
      • investigator1_telephone0713817486
      • investigator1_emailanmakokha@gmail.com
      • organisations_transferred_No
      • number_participants120
      • notification
      • approval_date29-07-2019
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted16-06-2018
      • is_child0
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reason
      • final_report(null)
      • implication_results(null)
      • quantity_imported(null)
      • quantity_dispensed(null)
      • quantity_destroyed(null)
      • quantity_exported(null)
      • balance_site(null)
      • final_date(null)
      • modified2019-07-29 20:47:06
      • created2018-06-11 17:06:36
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id438
        • application_id694
        • given_nameBENARD
        • middle_nameOCHIENG
        • family_nameWESONGA
        • qualificationMBChB, MPH
        • professional_addressP.O. BOX 19967-00202
        • telephone0722584574, 0733776421
        • emailbenard.wesonga@mmust.ac.ke
        • created2018-06-11 17:20:32
        • modified2018-06-16 16:53:15
    • SiteDetail(array)
      • 0(array)
        • id554
        • application_id694
        • county_id(null)
        • site_name
        • physical_address
        • contact_details
        • contact_person
        • site_capacity(null)
        • misc(null)
        • created2018-06-11 17:20:32
        • modified2018-06-16 16:53:15
        • County(empty)
    • Sponsor(array)
      • 0(array)
        • id347
        • application_id694
        • sponsorSelf
        • sponsor_type(null)
        • contact_person
        • addressP.O. BOX 19967-00202 Nairobi
        • telephone_number0722584572
        • fax_number
        • cell_number0722584572
        • email_addressbwesonga2@gmail.com
        • created2018-06-11 17:20:32
        • modified2018-06-16 16:53:15
  • 2(array)
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      • id854
      • user_id606
      • trial_status_id7
      • abstract_of_study<p>\n Background:  Vincristine is among the most widely used and potentially effective chemotherapeutic agents in pediatric oncology patients. However, in black African children it is often sub optimally dosed due to genetic differences in the metabolism of vincristine. This study aims to optimize the dosing regimen of vincristine using therapeutic drug monitoring while carefully monitoring toxicity.</p>\n<p>\n Design This will be a prospective cohort study. All children aged 2-14 years diagnosed with cancer and scheduled to receive vincristine can be included. After the administration of vincristine, blood samples will be taken. These will be shipped to and analyzed in the Netherlands to determine the vincristine concentration in each sample. Based on this, a dose advise will be given for subsequent vincristine administrations. This cycle will be repeated in total 3 times. Toxicity will be monitored by determination of the bilirubin, by questionnaires and by physical examination to check for signs of peripheral neuropathy. </p>\n<p>\n Results We aim to include 100 patients. The required dose to achieve a therapeutic vincristine level, will be compared to a historic cohort. The results will lead to an alteration in the dosing regimen of vincristine in all pediatric oncology patients in Kenya. </p>\n
      • study_title<p>\n CHildren treated with vincristine: A trial regarding Pharmacokinetics, DNA And Toxicity of targeted therapy In pediatric oncology patients.</p>\n
      • laymans_summary<p class=\"yiv4801908789\">\n <span style=\"font-size:12px;\"><span style=\"color: rgb(29, 34, 40);\">The aim of the study is to optimize treatment and improve survival for children on treatment for cancer by maximizing the use of Vincristine, a drug which is used in treatment of childhood cancer.</span></span></p>\n<p class=\"yiv4801908789\">\n <span style=\"font-size:12px;\"><span style=\"color: rgb(29, 34, 40);\">Baseline assessment to check presence of nerve injury, bilirubin levels and malnutrition will be done before 1st administration of regular Vincristine dose. Blood sample will be obtained by a finger prick for analysis of Vincristine concentration after the dose has been given. The dose of Vincristine will  be increased during the next administration when the Vincristine concentration below the level calculated as safe and in the absence of severe vincristine induced peripheral neuropathy or any other severe side effect. A second, third and fourth dose adaptation will be given if the above criteria is met after each dose adaptation. </span></span></p>\n<p class=\"yiv4801908789\">\n <span style=\"font-size:12px;\"><span style=\"color: rgb(29, 34, 40);\">The information from this study might lead to a change in treatment of a wide range of cancers for black African children worldwide, by demonstrating that these children benefit from higher doses of VCR without severely increasing Vincristine induced peripheral neuropathy</span></span>.</p>\n<style type=\"text/css\">\n</style>\n
      • short_titleCHAPATI
      • protocol_noECCT/22/03/05
      • version_no01/2020
      • date_of_protocol05-12-2019
      • study_drugVincristine
      • disease_conditionAcute Lymphoblastic Leukemia, Non-Hodgkins Lymphoma, Rhabdomyosarcoma, Neuroblastoma, Nephroblastoma, Retinoblastoma
      • 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_nameVincristine
      • product_type_medical_device_name
      • comparatorNo
      • comparator_name
      • comparator_registered
      • comparator_countries
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addresskugolinet@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_letter0
      • 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_applicantSandra Langat
      • declaration_date117-03-2022
      • declaration_principal_investigatorDr. Festus Muigai Njuguna
      • declaration_date217-03-2022
      • placebo_presentNo
      • study_objectives<p>\n 1. To determine the optimal vincristine dose among children receiving chemotherapy at MTRH </p>\n<p>\n 2. To evaluate the development and severity of peripheral neuropathy and liver toxicity in paediatric oncology patients receiving  optimized vincristine doses in MTRH</p>\n<p>\n 3. To study genetic variants that are associated with vincristine metabolism as well as the  development and severity of peripheral neuropathy </p>\n
      • principal_inclusion_criteria<p>\n 1. Black patients aged 2-14 years with a malignancy for which they are scheduled to receive a minimum of four VCR administrations as part of their treatment protocol: children who are treated for acute lymphoblastic leukemia, children who are treated for non-Hodgkin's lymphoma, children who are treated for rhabdomyosarcoma,  children who are treated for neuroblastoma, children who are treated for nephroblastoma and children who are treated for retinoblastoma</p>\n<p>\n 2.  Written informed consent </p>\n
      • principal_exclusion_criteria<p>\n  1. Severe malnutrition (Z score ≤2SD of weight for height)</p>\n<p>\n  2. Total bilirubin >3 times upper limit of normal</p>\n<p>\n  3. Pre-existent severe mental retardation e.g. Down syndrome </p>\n
      • primary_end_points<p>\n 1. Vincristine Induced Peripheral Neuropathy</p>\n
      • scope_diagnosis0
      • scope_prophylaxis0
      • scope_therapy1
      • scope_safety1
      • scope_efficacy0
      • scope_pharmacokinetic0
      • scope_pharmacodynamic1
      • scope_bioequivalence0
      • scope_dose_response1
      • scope_pharmacogenetic0
      • scope_pharmacogenomic1
      • scope_pharmacoecomomic0
      • scope_others0
      • scope_others_specify
      • trial_human_pharmacology0
      • trial_administration_humans0
      • trial_bioequivalence_study0
      • trial_other0
      • trial_other_specify
      • trial_therapeutic_exploratory0
      • trial_therapeutic_confirmatory0
      • trial_therapeutic_use1
      • design_controlledNo
      • site_capacity(null)
      • staff_numbers<p>\n We have 4 main staff members including a pediatrician, pharmacist, study coordinator and data assistant. The site facility is in a level six hospital, in a well equiped and aqequately staffed paediatric oncology ward.</p>\n<p>\n 1. Dr. Festus Njuguna - Pediatrician - Master of Medicine (Paediatrics) (2005-2008), Bachelor of Medicine and Bachelor Surgery (1994-2000). Has over ten years working experince as a paediatrician and 8 years as a researcher in the pediatric oncology field</p>\n<p>\n 2. Dr. Linet Kugo - Pharmacist - Master of Pharmacy (Epivigil) (2013-2015); Bachelor of Pharmacy (2004-2008); 4 years experience as an oncology pharmacist with over 10 years experince as a pharmacist.</p>\n<p>\n 3. Sandra Langat - Study Coordinator - Bsc. in Medical Microbiology (2004-2007), 11 years working experinece in data collection and research coordination.</p>\n<p>\n 4. Martha Kipngetich - Data Assistant - Diploma in Information Technology (2002-2003), BSc. in Information Technology (2014 - 2015), 10 years working experience in data management, IT administration and research.</p>\n
      • other_details_explanation<p>\n N/A</p>\n
      • other_details_regulatory_notapproved<p>\n None</p>\n
      • other_details_regulatory_approved<p>\n None</p>\n
      • other_details_regulatory_rejected
      • other_details_regulatory_halted
      • 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_areaMoi Teaching and Referral Hospital
      • single_site_physical_addressNandi Road, Eldoret, Kenya
      • single_site_contact_personDr. Festus Muigai Njuguna
      • single_site_telephone0721219761
      • multiple_sites_member_stateNo
      • multiple_countriesNo
      • multiple_member_states
      • number_of_sites
      • multi_country_list
      • data_monitoring_committeeYes
      • total_enrolment_per_siteN/A
      • total_participants_worldwide100
      • population_less_than_18_yearsYes
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerNo
      • population_childrenYes
      • population_adolescentYes
      • population_above_18No
      • population_adultNo
      • population_elderlyNo
      • gender_female1
      • gender_male1
      • subjects_healthyNo
      • subjects_patientsYes
      • subjects_vulnerable_populationsYes
      • subjects_women_child_bearingNo
      • subjects_women_using_contraceptionNo
      • subjects_pregnant_womenNo
      • subjects_nursing_womenNo
      • subjects_emergency_situationNo
      • subjects_incapable_consentYes
      • subjects_specifyAll the study subjects will be below 18 years hence consent will be given by their parents or legal guardians on their behalf.
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameFESTUS
      • investigator1_middle_nameMUIGAI
      • investigator1_family_nameNJUGUNA
      • investigator1_qualificationPEDIATRICIAN
      • investigator1_professional_addressMOI UNIVERSITY SCHOOL OF MEDICINE
      • investigator1_telephone0721219761
      • investigator1_emailmuigaifes2000@yahoo.com
      • organisations_transferred_No
      • number_participants100
      • notification
      • approval_date25-10-2022
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted18-03-2022
      • is_child0
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reasonReviewer comments 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)
      • modified2024-02-26 10:55:08
      • created2020-02-20 09:03:12
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id525
        • application_id854
        • given_nameFESTUS
        • middle_nameMUIGAI
        • family_nameNJUGUNA
        • qualificationPEDIATRICIAN
        • professional_addressMOI UNIVERSITY SCHOOL OF MEDICINE
        • telephone0721219761
        • emailmuigaifes2000@yahoo.com
        • created2020-02-20 09:21:18
        • modified2022-03-18 11:29:10
    • SiteDetail(array)
      • 0(array)
        • id696
        • application_id854
        • county_id(null)
        • site_name
        • physical_address
        • contact_details
        • contact_person
        • site_capacity(null)
        • misc(null)
        • created2020-02-20 09:21:18
        • modified2022-03-18 11:29:10
        • County(empty)
    • Sponsor(array)
      • 0(array)
        • id412
        • application_id854
        • sponsorPrincess Maxima Paediatric Oncology Center
        • sponsor_typeResearch Institution
        • contact_personProf. Gertjan Kaspers
        • addressHeidelberglaan 25, 3584 CS Utrecht, Netherlands
        • telephone_number+31889728751
        • fax_number
        • cell_number+31625710324
        • email_addressG.J.L.Kaspers@prinsesmaximacentrum.nl
        • created2020-02-20 09:21:18
        • modified2022-03-18 11:29:10
  • 3(array)
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style=\"mso-bidi-font-family:\nArial\">COAST overarching objective is to address the key research gaps in the therapeutic use of oxygen in resource-limited setting in order to provide a better evidence base for future management guidelines. <span style=\"color:black;\nmso-bidi-font-weight:bold\">The trial has been designed to address the poor outcomes of children in sub-Saharan Africa, which are associated with high rates of </span>in-hospital mortality 9-10% (for those with oxygen saturations between 80% and 92%) and 26-30% case fatality for those with oxygen saturations <80%, indicating that the current recommendations and/or management strategies are not working in practice. </span></p>\n<p class=\"MsoNormal\" style=\"margin-top:6.0pt\">\n <span style=\"mso-bidi-font-family:\nArial\">Despite over two decades of investment by WHO technologies group aimed at improving systems for delivering oxygen it appears not to have been afforded a high enough priority at both a global and a country level. Although oxygen is a <span class=\"st1\"><span style=\"mso-bidi-font-weight:bold\">basic element of hospital care, </span></span>the poor implementation of current treatment recommendations also <span class=\"st1\"><span style=\"mso-bidi-font-weight:bold\">stems from the lack of availability in many hospitals, or it cannot be used routinely due to unpredictable supply, faulty cylinders or limitations and interruptions of the electricity supply. This has resulted in </span></span>mismatch between supply of, and demand for, oxygen in many rural hospitals in developing countries<span class=\"st1\"><span style=\"mso-bidi-font-weight:bold\">. </span></span>Whilst the health burden of hypoxia, including morbidity, hospital admission and death have been realised, its potential economic burden for treating children with conditions leading to hypoxia is substantial. As a result there are major gaps between current treatment policies and implementation. These largely stem from the lack of relevant research to inform clinical management; consequently current treatment recommendations are based on weak evidence. <span style=\"color:black\">Systematic and policy reviews have indicated the need for formal evaluation of the </span>hypoxaemia threshold for which oxygen should be targeted and how best to administer oxygen.</span></p>\n<p class=\"MsoNormal\" style=\"mso-pagination:none;tab-stops:47.0pt 72.0pt;\nmso-layout-grid-align:none;text-autospace:none\">\n <span style=\"mso-bidi-font-family:\nArial\">COAST aims to provide the relevant evidence for policy makers and health services by evaluating key elements of an integrated management strategy in African hospitals on the basis of clinical effectiveness and costs. </span></p>\n<p class=\"MsoNormal\" style=\"mso-pagination:none;tab-stops:47.0pt 72.0pt;\nmso-layout-grid-align:none;text-autospace:none\">\n <span style=\"mso-bidi-font-family:\nArial\">COAST is a randomised controlled trial designed to </span><span style=\"mso-fareast-font-family:"MS Mincho";mso-bidi-font-family:Arial\">provide the evidence for the most <i style=\"mso-bidi-font-style:normal\">clinically-effective</i> and <i style=\"mso-bidi-font-style:normal\">cost-efficient</i> targeted use of oxygen as a life-saving treatment with respect to the </span><span style=\"mso-bidi-font-family:Arial\">optimal oxygen saturation threshold for treatment and mode of delivery in 4200 African children, aged 2 months to 12 years, presenting to hospital with respiratory distress complicated by hypoxia (defined as oxygen saturation (SaO₂)< 92%).<span style=\"mso-spacerun:yes\">  </span></span></p>\n<p class=\"MsoNormal\" style=\"mso-pagination:none;tab-stops:47.0pt 72.0pt;\nmso-layout-grid-align:none;text-autospace:none\">\n <span style=\"mso-bidi-font-family:\nArial;color:black;mso-bidi-font-weight:bold\">Children will be enrolled at admission to hospital over 2 years from 5 sites in 2 countries (</span><span style=\"mso-bidi-font-family:Arial\">Uganda and Kenya)<span style=\"color:black;\nmso-bidi-font-weight:bold\"> and followed for 28 days.<span style=\"mso-spacerun:yes\">  </span></span>The trial has a pragmatic design, to ensure this encompasses a spectrum of high-risk children, identified largely by clinical criteria, so that the results are applicable to health services in Africa, with limited access to health technologies.</span></p>\n<h2 style=\"margin-top:10.0pt;margin-right:0cm;margin-bottom:6.0pt;margin-left:\n7.1pt;mso-list:none;tab-stops:36.0pt\">\n <a name=\"_Toc437619370\"><span style=\"font-style:normal\">Primary objectives</span></a></h2>\n<p class=\"MsoNormal\">\n To establish whether:</p>\n<p class=\"MsoListParagraphCxSpFirst\" style=\"margin-bottom:10.0pt;mso-add-space:\nauto;text-indent:-18.0pt;line-height:115%;mso-list:l2 level1 lfo2\">\n <span style=\"font-family:Symbol;mso-fareast-font-family:Symbol;mso-bidi-font-family:\nSymbol;mso-bidi-font-weight:bold\"><span style=\"mso-list:Ignore\">·<span style=\"font:7.0pt "Times New Roman"\">       </span></span></span><span style=\"mso-bidi-font-weight:bold\">liberal oxygenation will decrease mortality compared with permissive hypoxia (usual care); and</span></p>\n<p class=\"MsoListParagraphCxSpLast\" style=\"margin-bottom:10.0pt;mso-add-space:\nauto;text-indent:-18.0pt;line-height:115%;mso-list:l2 level1 lfo2\">\n <span style=\"font-family:Symbol;mso-fareast-font-family:Symbol;mso-bidi-font-family:\nSymbol;mso-bidi-font-weight:bold\"><span style=\"mso-list:Ignore\">·<span style=\"font:7.0pt "Times New Roman"\">       </span></span></span><span style=\"mso-bidi-font-weight:bold\">high flow oxygen delivery will decrease mortality compared with low flow oxygen delivery (usual care).</span></p>\n<h2 style=\"margin-top:10.0pt;margin-right:0cm;margin-bottom:6.0pt;margin-left:\n7.1pt;mso-list:none;tab-stops:36.0pt\">\n <a name=\"_Toc437619371\">Secondary objectives</a></h2>\n<p class=\"MsoNormal\">\n The secondary objectives of COAST are:</p>\n<p class=\"MsoListParagraphCxSpFirst\" style=\"margin-bottom:10.0pt;mso-add-space:\nauto;text-indent:-18.0pt;line-height:115%;mso-list:l1 level1 lfo3\">\n <span style=\"font-family:Symbol;mso-fareast-font-family:Symbol;mso-bidi-font-family:\nSymbol\"><span style=\"mso-list:Ignore\">·<span style=\"font:7.0pt "Times New Roman"\">       </span></span></span>to assess the effectiveness in the speed and success of recovery from the initial respiratory failure;</p>\n<p class=\"MsoListParagraphCxSpMiddle\" style=\"margin-bottom:10.0pt;mso-add-space:\nauto;text-indent:-18.0pt;line-height:115%;mso-list:l1 level1 lfo3\">\n <span style=\"font-family:Symbol;mso-fareast-font-family:Symbol;mso-bidi-font-family:\nSymbol\"><span style=\"mso-list:Ignore\">·<span style=\"font:7.0pt "Times New Roman"\">       </span></span></span>to assess safety and quality of life;</p>\n<p class=\"MsoListParagraphCxSpMiddle\" style=\"margin-bottom:10.0pt;mso-add-space:\nauto;text-indent:-18.0pt;line-height:115%;mso-list:l1 level1 lfo3\">\n <span style=\"font-family:Symbol;mso-fareast-font-family:Symbol;mso-bidi-font-family:\nSymbol\"><span style=\"mso-list:Ignore\">·<span style=\"font:7.0pt "Times New Roman"\">       </span></span></span>to determine long-term effects of the delivery strategies; and</p>\n<p class=\"MsoListParagraphCxSpLast\" style=\"margin-bottom:10.0pt;mso-add-space:\nauto;text-indent:-18.0pt;line-height:115%;mso-list:l1 level1 lfo3\">\n <span style=\"font-family:Symbol;mso-fareast-font-family:Symbol;mso-bidi-font-family:\nSymbol\"><span style=\"mso-list:Ignore\">·<span style=\"font:7.0pt "Times New Roman"\">       </span></span></span>to identify whether the additional costs of each of the interventions are proportionate to the health benefits and to inform future widespread implementation in terms of value for money.</p>\n<p class=\"MsoNormal\" style=\"mso-pagination:none;tab-stops:47.0pt 72.0pt;\nmso-layout-grid-align:none;text-autospace:none\">\n <span style=\"mso-bidi-font-family:\nArial\"> </span></p>\n<p class=\"MsoNormal\" style=\"mso-pagination:none;tab-stops:47.0pt 72.0pt;\nmso-layout-grid-align:none;text-autospace:none\">\n <span style=\"mso-bidi-font-family:\nArial\">The trial will have two randomisations:</span></p>\n<p class=\"MsoNormal\" style=\"line-height:12.0pt;mso-pagination:none\">\n <b><span style=\"mso-bidi-font-family:Arial\">R1: For children with a baseline SaO₂<92% but ≥80%, randomisation to l</span></b><span style=\"mso-bidi-font-family:Arial\">iberal oxygenation delivered by either high flow or low flow versus a more conservative strategy (control: no oxygen) </span></p>\n<p class=\"MsoNormal\" style=\"line-height:12.0pt;mso-pagination:none\">\n <b><span style=\"mso-bidi-font-family:Arial\">R2: For children with a baseline SaO₂<80% and for those randomised to liberal oxygenation for R1, </span></b><span style=\"mso-bidi-font-family:Arial;mso-bidi-font-weight:bold\">h</span><span style=\"mso-bidi-font-family:Arial;color:black\">igh flow versus low flow delivery (routine care)</span></p>\n<p class=\"MsoNormal\" style=\"mso-pagination:none;tab-stops:47.0pt 72.0pt;\nmso-layout-grid-align:none;text-autospace:none\">\n <b style=\"mso-bidi-font-weight:\nnormal\"><span style=\"mso-bidi-font-family:Arial\"> </span></b></p>\n<p>\n <b style=\"mso-bidi-font-weight:normal\"><span style=\"font-size:11.0pt;\nline-height:105%;font-family:Calibri;mso-ascii-theme-font:minor-latin;\nmso-fareast-font-family:"ï¼­ï¼³ 明朝";mso-fareast-theme-font:minor-fareast;\nmso-hansi-theme-font:minor-latin;mso-bidi-font-family:Arial;mso-ansi-language:\nEN-GB;mso-fareast-language:EN-GB;mso-bidi-language:AR-SA\">R1 </span></b><span style=\"font-size:11.0pt;line-height:105%;font-family:Calibri;mso-ascii-theme-font:\nminor-latin;mso-fareast-font-family:"ï¼­ï¼³ 明朝";mso-fareast-theme-font:minor-fareast;\nmso-hansi-theme-font:minor-latin;mso-bidi-font-family:Arial;mso-ansi-language:\nEN-GB;mso-fareast-language:EN-GB;mso-bidi-language:AR-SA\">addresses the question of what threshold to give oxygen in children with hypoxia (above a threshold of SaO₂<span style=\"mso-bidi-font-weight:bold\">≥</span>80%); <b style=\"mso-bidi-font-weight:normal\">R2 </b>addresses how best to give oxygen all receiving to oxygen. For <b style=\"mso-bidi-font-weight:normal\">R1</b>, a cut off of <92% assesses a range of saturations that would be consistent with international recommendations for use of oxygen in sick children - providing important additional data about those at a higher threshold than currently recommended by WHO. Children randomised to control will receive low flow oxygen if they ever develop severe hypoxia (SaO₂<80%). All randomisations will be open. </span></p>\n
      • study_title<p>\n Childrens Oxygen Administration Strategies Trial</p>\n
      • laymans_summary<p>\n Lay title<br />\n Optimising and targeting oxygen treatment in sick children: The COAST trial<br />\n What is the problem?<br />\n Although oxygen is a basic element of hospital care, there are no relevant studies to guide which level of oxygen saturation or the best method of how to administer it (low flow or high flow) to improve outcome. In practice many children in low-income countries do not receive oxygen, despite being recommended, owing to the lack of its availability due to the high cost, or supplies that are unpredictable (erratic delivery of cylinders or electricity to power oxygen concentrators) resulting in mismatch between supply and demand. The outcomes of children in sub-Saharan Africa with pneumonia, remains poor with an in-hospital mortality 9-10% (for those with oxygen saturations between 80% and 92%) and 26-30% case fatality for those with oxygen saturations <80%, indicating that the current recommendations and/or management strategies are not working in practice.<br />\n What questions are we trying to answer?<br />\n COAST has been designed to identify which children would benefit from receiving oxygen and what would be the best delivery method. Although oxygen is a basic element of hospital care, this therapy is costly and supplies are inadequate and erratic in African hospitals.<br />\n COAST will address two related questions of oxygen therapy and one about nutrition supplementation:<br />\n 1. Who to give oxygen too?<br />\n We will examine whether or not giving oxygen improves outcomes for children who have a moderately low level of oxygen it is not certain what the best level to provide oxygen is and whether this results in a better outcome – so half of the children will receive oxygen and the other half will not. Children with severe hypoxia (<80%) will all receive oxygen as we are more confident about the benefits of oxygen in this group.<br />\n 2. How best to give oxygen?<br />\n For children receiving oxygen, we will compare whether giving oxygen at a higher flow compared with a lower flow (routine care) improves outcomes. High flow oxygen provides extra pressure to the airways to prevent them from collapsing after every exhalation. This helps reduce the effort of breathing, which is vital when lung infections can often lead to respiratory exhaustion and ultimately respiratory failure in critically sick children with limited access to relevant life support i.e. mechanical ventilation (the majority of hospitals in Africa).<br />\n 3. Nutritional Support<br />\n To establish whether supplementary feeding for 56-days (8 weeks) using Ready to Use Therapeutic Feeds (RUTF) in all children versus usual standard care will improve outcome at 90-days.<br />\n Where is the study taking place?<br />\n The study will take place in 5 hospitals in 2 African countries Kilifi County Hospital and Coast Provincial General Hospital (Kenya) and Mulago (Kampala) Mbale and Soroti Hospitals in Uganda.</p>\n
      • short_titleCOAST
      • protocol_noECCT/16/11/03
      • version_no1.1
      • date_of_protocol15-09-2016
      • study_drugOxygen
      • disease_conditionSevere pneumonia
      • 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_nameAirVO2 Nasal Oxygen interface
      • comparatorNo
      • comparator_name
      • comparator_registered
      • comparator_countries
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressctfuser@kemri-wellcome.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_countries1
      • applicant_addendum1
      • applicant_fees1
      • applicant_complete_form(null)
      • applicant_impd1
      • applicant_prev_data0
      • applicant_stability_data1
      • applicant_analysis_cert1
      • applicant_pictorial_sample1
      • applicant_gcp_training1
      • applicant_dsmb_charter1
      • applicant_detailed_budget1
      • applicant_indemnity_pi0
      • applicant_practice_license1
      • applicant_registration_ctr(null)
      • applicant_pan_african1
      • applicant_hard_copies(null)
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      • statistical_analysis_plan(null)
      • applicant_contractual_agreement(null)
      • declaration_applicantPatricia Njuguna
      • declaration_date110-11-2016
      • declaration_principal_investigatorKathryn Maitland
      • declaration_date210-11-2016
      • placebo_presentNo
      • study_objectives<p>\n Primary objectives</p>\n<p>\n To establish whether:</p>\n<ul>\n <li>\n liberal oxygenation will decrease mortality compared with permissive hypoxia (usual care); and</li>\n <li>\n high flow oxygen delivery will decrease mortality compared with low flow oxygen delivery (usual care).</li>\n <li>\n Supplementing feeds with RUTF will improve anthropometric outcomes at Day 90 and Day 180.</li>\n</ul>\n<p>\n The secondary objectives of COAST are:</p>\n<ul>\n <li>\n to assess the effectiveness in the speed and success of recovery from the initial respiratory failure;</li>\n <li>\n to assess safety and quality of life;</li>\n <li>\n to determine long-term effects of the delivery strategies; and</li>\n <li>\n to identify whether the additional costs of each of the interventions are proportionate to the health benefits and to inform future widespread implementation in terms of value for money.</li>\n</ul>\n<ol>\n <li value=\"1.1\">\n ctives</li>\n</ol>\n
      • principal_inclusion_criteria<p>\n Aged between 28 days to 12 years with a</p>\n<ul>\n <li>\n History of respiratory illness (cough, upper respiratory tract symptom or any respiratory symptoms, e.g. rapid breathing or increase work of breathing)</li>\n <li>\n Hypoxia (pulse oximetry reading of SaO₂ <92% recorded in room air over 5 minutes)</li>\n <li>\n Plus <em>any one of the following</em> signs of severe pneumonia (from 2013 WHO clinical definitions for pneumonia [<a href=\"#_ENREF_55\" title=\", 2013 #71\">55</a>]):</li>\n</ul>\n<ol style=\"list-style-type:lower-alpha;\">\n <li>\n Sign of respiratory distress (any one of):\n <ul style=\"list-style-type:circle;\">\n <li>\n severe lower chest wall in-drawing</li>\n <li>\n use of auxiliary muscles</li>\n <li>\n head nodding</li>\n <li>\n inability to feed because of respiratory problems</li>\n </ul>\n </li>\n <li>\n Suspected pneumonia\n <ul style=\"list-style-type:circle;\">\n <li>\n fast breathing:\n <ul>\n <li>\n age 2–11 months: ≥ 50/minute</li>\n <li>\n age 1–5 years: ≥ 40/minute</li>\n <li>\n age 5-12 years ≥ 30/minute</li>\n </ul>\n </li>\n <li>\n chest auscultation signs:\n <ul>\n <li>\n decreased breath sounds</li>\n <li>\n bronchial breath sounds</li>\n <li>\n crackles</li>\n <li>\n abnormal vocal resonance (decreased over a pleural effusion or empyema, increased over lobar consolidation)</li>\n <li>\n pleural rub</li>\n </ul>\n </li>\n </ul>\n </li>\n <li>\n Signs of pneumonia with a general danger sign:</li>\n</ol>\n<ul style=\"list-style-type:circle;\">\n <li>\n inability to breastfeed or drink</li>\n <li>\n lethargy or unconscious</li>\n <li>\n convulsions</li>\n</ul>\n
      • principal_exclusion_criteria<ul>\n <li>\n Known uncorrected cyanotic heart disease</li>\n <li>\n Assent/consent refusal by parent/carer</li>\n <li>\n Previously recruited to COAST</li>\n <li>\n Already received oxygen for this episode of illness</li>\n</ul>\n
      • primary_end_points<p>\n Primary</p>\n<p>\n 48 hour mortality post randomisation</p>\n<p>\n Secondary</p>\n<ul>\n <li>\n Treatment failure at 48 hours</li>\n <li>\n Survival to 28 days</li>\n <li>\n Neurocognitive sequelae at 28 days</li>\n <li>\n Disability-free survival to 28 days</li>\n <li>\n Time to hypoxia (≥92%) resolution during initial hospital stay</li>\n <li>\n Length of initial hospital stay</li>\n <li>\n Re-admission to hospital by 28 days</li>\n <li>\n Anthropometric status by 28 days</li>\n</ul>\n<p>\n Resolution of neurocognitive sequelae at 90 days (for those with neurocognitive sequelae at 28 days)</p>\n
      • scope_diagnosis0
      • scope_prophylaxis0
      • scope_therapy1
      • scope_safety0
      • 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_exploratory0
      • trial_therapeutic_confirmatory1
      • trial_therapeutic_use0
      • design_controlledYes
      • site_capacity(null)
      • staff_numbers<p>\n Kenya: KEMRI Wellcome Trust Programme, Kilifi County Hospital (KCH). The clinical programme at KCH is a well-established research centre on the coast of Kenya. It has been the site of several clinical studies on severe malaria including two large phase III trials (AQUAMAT and FEAST). Coast Provincial General Hospital (CPGH) is based in the second largest city in Kenya (Mombasa) and has conducted in collaboration with KWTRP a number of research studies and Phase III clinical trials in children admitted to CPGH .</p>\n<p>\n Uganda: Mulago National Referral Hospital. Mbale Regional Referral Hospital and Soroti Regional Referral Hospital. Mulago, Mbale and Soroti hospitals have annual admissions to the paediatric ward of 18,000, 20,000 and 8000 respectively. There has been considerable research capacity development in the last five years, with these three sites involved in the FEAST trial and currently conducting a large multicentre trial of transfusion trial (TRACT).</p>\n<p>\n The five centres in Africa represent a spectrum of intensity of malaria transmission, from perennial and high (in Mbale and Soroti) to seasonal and meso-endmic (in Kampala, Mombasa and Kilifi). Mulago and CPGH are located within large urban areas, whereas the populations that utilise Mbale, Soroti and Kilifi are more typically rural; however Mbale has a few slum developments within the town.</p>\n<p>\n Central grant funding will be available for participating sites to support infrastructural upgrade to ensure basic life resuscitation, standard medications available and oxygen can be delivered continuously and sufficient staff to run the trial - each centre have 2 clinician, 5 nurses and laboratory staff. Fischer and Paykel have donated sufficient AIRVO machines (5 per site) , tubing and nasal prongs for oxygen administration.</p>\n
      • other_details_explanation<p>\n The trial is in children with  severe pneumonia in low income settings</p>\n
      • other_details_regulatory_notapproved<p>\n not applicable</p>\n
      • other_details_regulatory_approved<p>\n Uganda March 2016</p>\n
      • other_details_regulatory_rejected<p>\n None</p>\n
      • other_details_regulatory_halted<p>\n None</p>\n
      • estimated_duration30 months
      • design_controlled_randomisedYes
      • design_controlled_openYes
      • design_controlled_single_blindNo
      • design_controlled_double_blindNo
      • design_controlled_parallel_groupYes
      • design_controlled_cross_overNo
      • design_controlled_otherNo
      • design_controlled_specify
      • design_controlled_comparatorHigh Flow Oxygen versus L
      • design_controlled_other_medicinalYes
      • design_controlled_placeboNo
      • design_controlled_medicinal_otherYes
      • design_controlled_medicinal_specifyAirVO oxgen nasal delivery device
      • 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_states2 countries 5 sites
      • number_of_sites2
      • multi_country_listUganda (Mbale and Soroti Regional Referral Hospitals) Mulago National Referral Hospital\nKenya (as above)
      • data_monitoring_committeeYes
      • total_enrolment_per_sitePer site a minimum of 400 and maximum of 800
      • total_participants_worldwide4200
      • 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_healthyNo
      • subjects_patientsYes
      • subjects_vulnerable_populationsYes
      • subjects_women_child_bearingNo
      • subjects_women_using_contraceptionNo
      • subjects_pregnant_womenNo
      • subjects_nursing_womenNo
      • subjects_emergency_situationYes
      • subjects_incapable_consentYes
      • subjects_specifyChildren aged 2months-12 years admitted to hospital with severe pneumonia and hypoxia
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_namePatricia
      • investigator1_middle_name
      • investigator1_family_nameNjuguna
      • investigator1_qualificationMMed PhD
      • investigator1_professional_addressKEMRI Wellcome Trust Programme CRG, Kilifi
      • investigator1_telephone254 41 7522063
      • investigator1_emailPNjuguna@kemri-wellcome.org
      • organisations_transferred_Yes
      • number_participants1200 across 2 sites over 3 years
      • notification<p>\n None</p>\n
      • approval_date22-02-2017
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted26-02-2020
      • is_child0
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reason
      • final_report<p>\n The trial was stopped prematurely by the Trial Steering Committee on the grounds of feasibility. Between 14th Feb 2017 and when enrolment ceased 28th Feb 2020, 1842, eligible children were enrolled into the COAST trial and included in all analyses. In the severe hypoxemia stratum, 388 children were enrolled,194 children were randomized to High Flow Nasal Therapy, and 194 to Low Flow Oxygen. In the hypoxemia stratum,1454 children were enrolled and, 363 were randomized to HFNT, 364 to LFO, and 727 to permissive hypoxemia.</p>\n<p>\n At the point of termination, the COAST trial was unable to answer the two specific hypotheses it was designed to address. First, whether liberal oxygenation therapy for children with hypoxemia (SpO2 80–91%) is superior to permissive hypoxemia. Secondly, there were insufficient data to demonstrate that HFNT was superior to LFO.</p>\n<p>\n Across both strata, HFNT administration was also relatively oxygen-sparing, using room air/oxygen blends without any evidence of harm. In the hypoxemia stratum in many cases HFNT was provided on room air, leading to correction of hypoxemia. Although the trial does not provide definitive data to inform treatment guidelines, the knowledge acquired from the trial adds a new level of uncertainty to the liberal use of oxygen as a supportive therapy.</p>\n<p>\n In the case of severe pneumonia, pre-existing evidence demonstrating clear benefits of oxygen therapy was poor hence the trial was both ethically and scientifically sound.</p>\n<p>\n While oxygen, as a supportive therapy, has been considered the standard treatment for pneumonia for a large part of the last century, the recognition of potential oxygen toxicity is relatively recent. In several areas of emergency care and resuscitation, the use of oxygen is now being challenged by emerging evidence from clinical trials, including in pediatric populations and systematic reviews.</p>\n<p>\n Regarding demand on health services, the routine use of pulse oximetry to target oxygen therapy is poorly implemented despite having been recommended by WHO for triage of sick children. Hence, oxygen therapy is generally targeted by non-specific clinical signs that predict hypoxemia poorly, thus exposing large numbers of children without hypoxemia to oxygen therapy, and raising questions over safety, cost, and demand for a constrained health resource. Our findings indicate that hypoxemia in children with severe pneumonia can be corrected without additional oxygen.</p>\n<p>\n Recognizing the resource limitations and costs of oxygen therapy, the protocol incorporated relatively oxygen sparing strategies in the investigational groups (HFNT and permissive hypoxemia) and vital sign monitoring to ensure early weaning in both liberal (HFNT and LFO)</p>\n<p>\n strategies.</p>\n<p>\n COAST trial represents the largest trial of oxygen therapy ever conducted in children and the only multicenter controlled trial.</p>\n<p>\n We, therefore, proposed that HFNT was a feasible alternative source of respiratory support owing to its relative simplicity in implementation, humidification, low risk of nosocomial infection. In addition, the ability to blend both oxygen and room air to deliver positive end-expiratory pressure, thus, limiting exposure to high concentrations of oxygen (and potential toxicity) and with the prospect of reducing costs to health services.</p>\n<p>\n  </p>\n
      • implication_results<p>\n <span style=\"font-size: 9pt; font-family: Arial, sans-serif;\">Our findings supports the need for future trials with similar designs, particularly in settings where access to oxygen and/or mechanical respiratory support are restricted. The scale of the mortality reduction of High Flow Nasal Therapy over Low Flow Oxygen, particularly in severely hypoxaemic children warrants further investigation. Oxygen-sparing strategies potentially offer cost-effective approaches to reducing overall oxygen requirements in overburdened health services and adds to the general findings in critical care that less is more.<o:p></o:p></span></p>\n
      • quantity_importedN/A
      • quantity_dispensedN/A
      • quantity_destroyedN/A
      • quantity_exportedN/A
      • balance_siteN/A
      • final_date0000-00-00
      • modified2024-07-10 15:32:30
      • created2016-11-02 15:20:40
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id366
        • application_id567
        • given_nameKathryn
        • middle_name
        • family_nameMaitland
        • qualificationMBBS FRCP Phd
        • professional_addressImperial College, London
        • telephone+4420 7594 3891
        • emailk.maitland@imperial.ac.uk
        • created2016-11-02 15:21:12
        • modified2020-02-26 10:02:14
    • SiteDetail(array)
      • 0(array)
        • id445
        • application_id567
        • county_id3
        • site_nameKilifi County Hospital
        • physical_addressHospital Grounds, Off Bofa Road, Kilifi, Kenya
        • contact_detailsn/a
        • contact_personStudy PI: Dr Patricia Njuguna
        • site_capacity(null)
        • misc(null)
        • created2016-11-02 15:21:12
        • modified2020-02-26 10:02:14
        • County(array)
          • id3
          • county_nameKilifi
          • created2012-05-31 16:15:49
          • modified2012-05-31 16:15:49
      • 1(array)
        • id446
        • application_id567
        • county_id1
        • site_nameCoast Provincial General Hospital
        • physical_addressBondeni, Kisauni Rd, Mombasa, Kenya
        • contact_detailsn/a
        • contact_personDr Victor Bandika
        • site_capacity(null)
        • misc(null)
        • created2016-11-02 15:40:41
        • modified2020-02-26 10:02:14
        • County(array)
          • id1
          • county_nameMombasa
          • created2012-05-31 16:15:11
          • modified2012-07-09 13:06:23
    • Sponsor(array)
      • 0(array)
        • id292
        • application_id567
        • sponsorImperial College, London
        • sponsor_typeOthers
        • contact_personGary Roper
        • addressJoint Research Office, Sir Alexander Fleming Building, Imperial College, Exhibition Road, London, United Kingdom, SW7 2AZ
        • telephone_number+44(0)2075949484
        • fax_numbern/a
        • cell_numbern/a
        • email_addressgary.roper@imperial.ac.uk
        • created2016-11-02 15:21:12
        • modified2020-02-26 10:02:14
  • 4(array)
    • Application(array)
      • id884
      • user_id81
      • trial_status_id5
      • abstract_of_study<p>\n <strong>Study Title:</strong> The Chloroquine/hydroxychloroquin prevention of coronavirus disease (COVID-19) in the healthcare setting; a randomized, placebo-controlled prophylaxis study (COPCOV)</p>\n<p>\n <strong>Trial registration:</strong> NCT04303507 (PACTR registration pending)</p>\n<p>\n <strong>Study design:</strong> Randomized double-blind, placebo controlled trial</p>\n<p>\n <strong>Participants</strong>: Healthcare workers aged ≥18 years in a healthcare facility delivering direct care to patients with either proven or suspected COVID-19.</p>\n<p>\n <strong>Planned sample size:</strong> 40, 000 worldwide, maximum of 1,600 in Kenya</p>\n<p>\n <strong>Planned Study Period:</strong> 18 months; individual trial duration maximum 5 months</p>\n<p>\n <strong>Objectives:</strong></p>\n<p>\n               <u>Primary</u>: To determine if hydroxychloroquine prophylaxis prevents symptomatic COVID-19 infection in healthcare workers</p>\n<p>\n               <u>Secondary: </u></p>\n<p>\n               a) To determine if hydroxychloroquine prophylaxis attenuates COVID-19 infections</p>\n<p>\n               b) To determine if hydroxychloroquine prophylaxis prevents asymptomatic infection with SARS-CoV-2, the virus that causes COVID-19</p>\n<p>\n               c) To determine if hydroxychloroquine prophylaxis prevents all-cause symptomatic acute respiratory illnesses</p>\n<p>\n               <u>Tertiary</u></p>\n<ol>\n <li>\n To characterize genetic and baseline biochemical markers associated with symptomatic COVID-19, respiratory illness and disease severity</li>\n <li>\n To assess the impact of hydroxychloroquine prophylaxis on work and behavior during the pandemic</li>\n <li>\n To perform health economic alalyses to assess the impact of hydroxychloroquine prophylaxis on costs and quality of life measures</li>\n</ol>\n<p>\n  </p>\n<p>\n  </p>\n<p>\n  </p>\n
      • study_title<p>\n Chloroquine/ hydroxychloroquine prevention of coronavirus disease (COVID-19) in the healthcare setting; a randomised, placebo-controlled prophylaxis study (COPCOV)</p>\n
      • laymans_summary<p>\n <strong>Formal Title:</strong> Chloroquine/ hydroxychloroquine prevention of coronavirus disease (COVID-19) in the healthcare setting; a randomised, placebo-controlled prophylaxis study (COPCOV)</p>\n<p>\n <strong>Lay Title:</strong> Hydroxychloroquine for prevention of COVID-19</p>\n<p>\n <strong>What is the problem/background?</strong></p>\n<p>\n Coronavirus disease (COVID-19), which is caused by the virus known as SARS-CoV-2, was first reported in Wuhan China in December 2019 and has so far affected over 2 million people globally and has been declared a global pandemic by the World Health Organisation (WHO). There is no proven effective prophylaxis, no proven treatment and no vaccine. As of writing, there are more than 200,000 deaths globally with 1,017 in Africa. We are in a race against time to find effective treatments and preventive measures as the pandemic grows. There is major concern that COVID-19 could devastate countries with limited capacity for testing and case isolation, and overwhelm their fragile healthcare systems. The high risk to healthcare workers, as seen with SARS-CoV previously, and now in Wuhan with COVID-19, could be a major threat to healthcare operations overall. People who look after patients with COVID-19 infections are at increased risk of infection. There is an urgent need to identify drugs which can prevent the spread of infection but also that prevent high-risk groups, like those working in healthcare facilities, from getting the infection, so they can continue to care for patients and protect their families.</p>\n<p>\n <strong>What questions are we trying to answer?</strong></p>\n<p>\n We are conducting a study to find out whether a drug called hydroxychloroquine may prevent development of coronavirus illness. Chloroquine, the medicine very similar to hydroxychloroquine, was used very widely for the prevention and treatment of malaria for over 50 years and also to treat rheumatoid arthritis. People have taken it for many years at a time. It is considered very safe, and it may have effects against the virus. We would also like to find out if hydroxychloroquine lessens the symptoms for those who do get corona virus infection while taking it.</p>\n<p>\n <strong>Where is the study taking place, how many people does it involve and how are they selected?</strong></p>\n<p>\n The study will be conducted from four sites in Kenya; Kilifi, Mombasa, Nairobi and Kisumu. We aim to recruit up to 1,600  participants across all sites. We will enroll health care workers who are at high risk of exposure to SARS-CoV-2 infection.</p>\n<p>\n <strong>What does the study involve for those who are in it?</strong></p>\n<p>\n Participants will answer some questions about their medical history, provide 25 ml of blood for testing, take study tablets (hydroxychloroquine or placebo) and record temperature and respiratory symptoms via mobile phone. Participants will take the study tablets for 90 days. They will be requested to come to the study clinic on days 30,60 and 90, plus a final visit being conducted at 5 months. Those reporting respiratory symptoms during the course of the study will have nasal and throat swabs collected for testing for the presence of respiratory viruses.</p>\n<p>\n W<strong>hat are the benefits and risks/costs of the study for those involved?  </strong></p>\n<p>\n There is a potential benefit of direct protection from corona virus infection if the drug works for those who are in the hydroxychloroquine arm. Individuals in the placebo arm may also benefit from indirect protection through decreased ability of the infection to spread.Risks related to hydroxychloroquine are very low.</p>\n<p>\n <strong>How will the study benefit society?</strong></p>\n<p>\n The study may show a benefit of using hydroxychloroquine which would save many lives around the world, or alternatively may show hydroxychloroquine prophylaxis is ineffective so trials can move on to evaluate other possible interventions.</p>\n<p>\n <strong>When does the study start and finish?</strong></p>\n<p>\n Following ethical and regulatory approval, the study is expected to take 18 months.</p>\n<p>\n  </p>\n
      • short_titleCOPCOV
      • protocol_noECCT/20/05/02
      • version_no4.0
      • date_of_protocol09-04-2020
      • study_drug Hydroxychloroquine
      • disease_conditionCOVID 19
      • 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_nameHydroxychloroquine sulphate
      • product_type_medical_device_name
      • comparatorNo
      • comparator_name
      • comparator_registered
      • comparator_countries
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressregulatory@kemri-wellcome.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_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_plan0
      • applicant_contractual_agreement0
      • declaration_applicant0722417507
      • declaration_date120-05-2020
      • declaration_principal_investigatorAnthony Etyang
      • declaration_date220-05-2020
      • placebo_presentYes
      • study_objectives<p>\n         <u>Primary</u>:</p>\n<p>\n         To determine if hydroxychloroquine prophylaxis prevents symptomatic COVID-19 infection in healthcare workers</p>\n<p>\n         <u>Secondary:</u></p>\n<ol>\n <li>\n To determine if hydroxychloroquine prophylaxis attenuates COVID-19 infections</li>\n <li>\n To determine if hydroxychloroquine prophylaxis prevents asymptomatic infection with SARS-CoV-2, the virus that causes COVID-19</li>\n <li>\n To determine if hydroxychloroquine prophylaxis prevents all-cause symptomatic acute respiratory illnesses</li>\n</ol>\n<p>\n         <u>Tertiary</u></p>\n<ol>\n <li>\n To characterize genetic and baseline biochemical markers associated with symptomatic COVID-19, respiratory illness and disease severity</li>\n <li>\n To assess the impact of hydroxychloroquine prophylaxis on work and behavior during the pandemic</li>\n <li>\n To perform health economic alalyses to assess the impact of hydroxychloroquine prophylaxis on costs and quality of life measures</li>\n</ol>\n<p>\n  </p>\n
      • principal_inclusion_criteria<ol>\n <li>\n 18 years and above</li>\n <li>\n Participant is willing and able to give informed consent for participation in the study and agrees with the study and its conduct</li>\n <li>\n Agrees not to self-medicate with chloroquine, hydroxychloroquine or other potential antivirals (e.g. not on HAART that includes LPV/r as part of the regimen)</li>\n <li>\n Not previously diagnosed with COVID-19</li>\n <li>\n Not currently symptomatic with an acute respiratory infection (ARI)</li>\n <li>\n Participant works in a healthcare facility delivering direct care to patients with either proven or suspected COVID-19</li>\n <li>\n Possesses an internet-enabled smartphone (Android or iOS) or computer</li>\n</ol>\n<p>\n  </p>\n
      • principal_exclusion_criteria<ol>\n <li>\n Hypersensitivity reaction to hydroxychloroquine or 4-aminoquinolines</li>\n <li>\n Contraindication to taking hydroxychloroquine as prophylaxis, e.g. known epileptic, known creatinine clearance < 10 ml/min </li>\n <li>\n Already taking chloroquine, hydroxychloroquine or 4-aminoquinolines</li>\n <li>\n Taking a concomitant medication described in section 8.5 of the master protocol, which cannot be safely stopped</li>\n <li>\n Known retinal disease</li>\n <li>\n Inability to be followed up for the trial period</li>\n <li>\n Known prolonged QT syndrome (ECG will be required for potential participants who report having a heart condition)</li>\n <li>\n Is enrolled in another clinical trial (however participants will be allowed to participate in observational studies)</li>\n</ol>\n<p>\n  </p>\n
      • primary_end_points<p>\n The number of symptomatic COVID-19 infections will be compared between participants randomised to chloroquine or hydroxychloroquine, and placebo groups.</p>\n
      • scope_diagnosis0
      • scope_prophylaxis1
      • scope_therapy0
      • 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_exploratory0
      • trial_therapeutic_confirmatory1
      • trial_therapeutic_use0
      • design_controlledYes
      • site_capacity(null)
      • staff_numbers<table border=\"1\" cellpadding=\"0\" cellspacing=\"0\" style=\"width:515px;\" width=\"515\">\n <tbody>\n <tr>\n <td style=\"width:84px;\">\n <p>\n <strong>Sites</strong></p>\n </td>\n <td style=\"width:195px;\">\n <p>\n <strong>KEMRI - CGMRC</strong></p>\n </td>\n <td style=\"width:235px;\">\n <p>\n <strong>KEMRI-CGHR</strong></p>\n </td>\n </tr>\n <tr>\n <td style=\"width:84px;\">\n <p>\n Personnel</p>\n </td>\n <td style=\"width:195px;\">\n <p>\n Medical officer-4</p>\n <p>\n Clinical officer coordinator-1</p>\n <p>\n Clinical Officers -6</p>\n <p>\n Field workers- 9</p>\n <p>\n Pharmacists-2</p>\n <p>\n Nurses -5</p>\n <p>\n Data Manager -1</p>\n <p>\n Data Supervisor-1</p>\n <p>\n Lab techs -6</p>\n <p>\n Lab managers-3</p>\n </td>\n <td style=\"width:235px;\">\n <p>\n Medical officer 2</p>\n <p>\n Clinical officer Coordinator-1</p>\n <p>\n Clinical Officers -3</p>\n <p>\n Field workers-3</p>\n <p>\n Pharmacists-1</p>\n <p>\n Data Manager -1</p>\n <p>\n Data Supervisor -1</p>\n <p>\n Lab techs-4</p>\n <p>\n  </p>\n </td>\n </tr>\n </tbody>\n</table>\n<p>\n <span font-size:=\"\" style=\"color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">In both sites the clinical team are trained in basic life support and resuscitation facilitaties are available</span></p>\n
      • other_details_explanation<p>\n Potential trial sites include:</p>\n<p>\n  </p>\n<p>\n <strong>The Faculty of Tropical Medicine (FTM), Mahidol University, Bangkok</strong>, is affiliated and partnered with the Mahidol Oxford Tropical Medicine Research Unit (MORU), which have successfully collaborated together for more than 40 years in the management of Tropical diseases. FTM is the only faculty specialising in tropical medicine in Thailand and runs the Hospital for Tropical Diseases in Bangkok. Both FTM and MORU are fitted with state-of-the-art molecular diagnostic testing facilities.</p>\n<p>\n <strong>Sunpasithiprasong Hospital, Ubon Ratchathani</strong>. Situated in the East of Thailand on the Laos border, this long-term 1200 bed hospital and MORU collaborator for 34 years has dedicated on-site study nurses currently conducting clinical trials.</p>\n<p>\n <strong>Udon Thani Hospital, Udon Thani</strong>, (800 beds) is situated in the Northeast of Thailand adjacent to Lao’s capital, Vientiane, and has been a study site for previous trials with successful collaboration.</p>\n<p>\n <strong>Chiangrai Clinical Research Unit (CCRU)</strong> is a MORU-affiliated unit in the North of Thailand. It has a full-time team of a clinician researcher, study nurses and laboratory staff, with a laboratory based in the Prachanukroh Hospital (760 beds).</p>\n<p>\n <strong>Shoklo Malaria Research Unit (SMRU), Mae Sot</strong>, based on the Thai-Myanmar border in the West of Thailand is the largest of the MORU-affiliated sites. Originally set up to provide basic healthcare and malaria treatment to Myanmar migrants fleeing civil war in Kayin (Karen) state, this unit now supports and runs several in-patient clinics, has a fully accredited laboratory able to test for COVID-19 and other respiratory pathogens and works closely with the Thai Governmental hospital in the city.</p>\n<p>\n <strong>Lao-Oxford-Mahosot Hospital-Wellcome Trust Research Unit (LOMWRU)</strong>, a clinical research unit embedded in the 450 bed Mahosot Hospital in Lao PDR’s capital, Vientiane, conducts clinical research on diseases of regional public health importance, and has recently developed capability for testing for SARS-CoV-2, as well as other respiratory viruses and causes of febrile illness. Audrey Dubot-Pérès, the head of Virology at LOMWRU and also works at the Institut de Recherche pour le Développement (IRD) in the Unit of Emerging Viruses (Aix-Marseille Univ-IRD 190-Inserm 1207-IHU Méditerranée Infection), Marseille. Additionally LOMWRU has excellent links, and is currently collaborating in, 5 provincial hospitals, which could be potential study sites: Xieng Khuang; Luang Namtha; Salavan; Savannakhet; and Phonhong. These provinces provide health care to the provinces which have porous borders with China, Myanmar and several geographically distinct regions of Thailand and Vietnam.</p>\n<p>\n <strong>Myanmar-Oxford Clinical Research Unit (MOCRU)</strong> is a MORU-affiliated unit in Yangon, Myanmar with strong links to Medical Action Myanmar (MAM) a non-governmental organisation which runs a network of 2,000 health workers and 10 clinics as well as strong collaborative links with the Myanmar Ministry of Health and several public hospitals in Yangon and Mandalay. </p>\n<p>\n <strong>Cambodia-Oxford Medical Research Unit (COMRU)</strong> a collaboration between MORU and the Angkor Hospital for Children (AHC) in Siem Reap, Cambodia. This collaboration started in 2006 and led by Professor Paul Turner, head of COMRU, and Dr Claudia Turner, CEO of AHC, provides free, quality healthcare to approximately 450 children a day, as well as high-quality research. The laboratory is equipped to do respiratory virus testing, including COVID-19 as well as whole genome sequencing of isolates. Given the volume of children presenting with respiratory illnesses, COVID-19 could quite easily spread to healthcare providers and back out to the community.</p>\n<p>\n <strong>Hospital of Tropical Diseases (HTD), Ho Chi Minh City, Vietnam</strong> The Oxford University Clinical Research Unit (OUCRU), our sister unit based in the HTD, has a long history of conducting hospital-based clinical trials and was at the forefront of the research response to Avian Influenza in 2004 led by Professor Jeremy Farrar. HTD is a regional referral hospital serving a population of 38 million in the South of the country.</p>\n<p>\n <strong>The Christian Medical College (CMC), Vellore, India</strong>. An institution currently collaborating with MORU, Bangkok on the biggest scrub typhus trial ever conducted and the only trial on severe scrub typhus. CMC comprises 3,000 hospital beds across 6 campuses providing primary to quaternary care management of patients. CMC consistently ranks as one of the top medical institutions in India.</p>\n<p>\n <strong>Other sites including, but not limited to sites in the UK, Italy, France, Switzerland, the Netherlands, Indonesia, Bangladesh, Pakistan, Malaysia, Kenya, Uganda, Malawi, Zambia, South Africa, Cameroon, Niger and the Democratic Republic of the Congo.</strong></p>\n<p>\n  </p>\n<p>\n  </p>\n
      • other_details_regulatory_notapproved<p>\n N/A</p>\n
      • other_details_regulatory_approved<p>\n N/A</p>\n
      • other_details_regulatory_rejected<p>\n N/A</p>\n
      • other_details_regulatory_halted<p>\n N/A</p>\n
      • estimated_duration18 Months
      • design_controlled_randomisedYes
      • design_controlled_openNo
      • design_controlled_single_blindNo
      • design_controlled_double_blindYes
      • design_controlled_parallel_groupYes
      • design_controlled_cross_overNo
      • design_controlled_otherNo
      • design_controlled_specify
      • design_controlled_comparatorPlacebo
      • design_controlled_other_medicinalNo
      • design_controlled_placeboYes
      • 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_states50-100 sites
      • number_of_sites2
      • multi_country_listEuropean and African sites
      • data_monitoring_committeeYes
      • total_enrolment_per_site800
      • total_participants_worldwide40000
      • 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_healthyYes
      • subjects_patientsNo
      • subjects_vulnerable_populationsNo
      • subjects_women_child_bearingNo
      • subjects_women_using_contraceptionNo
      • subjects_pregnant_womenNo
      • subjects_nursing_womenNo
      • subjects_emergency_situationNo
      • subjects_incapable_consentNo
      • subjects_specify
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameClara
      • investigator1_middle_nameAtieno
      • investigator1_family_nameAgutu
      • investigator1_qualificationMBChB, MPH, MSc
      • investigator1_professional_addressKEMRI Wellcome Trust Research Programme, P O Box 230, 80108 Kilifi
      • investigator1_telephone0720735000
      • investigator1_emailCAgutu@kemri-wellcome.org
      • organisations_transferred_Yes
      • number_participants1600
      • notification
      • approval_date04-09-2020
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted19-12-2021
      • is_child0
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reasonEdwardabwao
      • final_report<p data-pm-slice=\"1 1 []\">\n Executive Summary: COPCOV Trial</p>\n<p>\n Title: Chloroquine/ Hydroxychloroquine Prevention of Coronavirus Disease (COVID-19) in the Healthcare Setting: A Randomised, Placebo-Controlled Prophylaxis Study (COPCOV)</p>\n<p>\n  </p>\n<p>\n Introduction</p>\n<p>\n The COPCOV trial was conducted to investigate whether hydroxychloroquine (HCQ) and chloroquine (CQ) could serve as effective preventive measures against COVID-19, particularly for healthcare workers at high risk of exposure. Given the urgent need for prophylactic solutions at the onset of the COVID-19 pandemic, the study aimed to determine the efficacy and safety of these widely-used antimalarial drugs in preventing symptomatic and asymptomatic infections.</p>\n<p>\n  </p>\n<p>\n Key Findings</p>\n<p>\n Safety and Tolerability:</p>\n<p>\n Both HCQ and CQ were found to be safe and well-tolerated, with no significant adverse events recorded among participants receiving the drugs.</p>\n<p>\n  </p>\n<p>\n Efficacy:</p>\n<p>\n The trial demonstrated a 15% reduction in symptomatic COVID-19 cases among participants receiving HCQ/CQ compared to the placebo group, but there was no significant difference in asymptomatic cases.</p>\n<p>\n  </p>\n<p>\n Impact on Respiratory Illness:</p>\n<p>\n Participants in the HCQ/CQ group experienced fewer respiratory illnesses overall, with fewer workdays lost due to illness compared to the placebo group.</p>\n<p>\n  </p>\n<p>\n Limitations:</p>\n<p>\n The study faced challenges due to the smaller-than-expected sample size, influenced by the widespread rollout of COVID-19 vaccines, which diminished the urgency for chemoprevention studies. Additionally, controversies surrounding the use of HCQ contributed to delays.</p>\n<p>\n  </p>\n<p>\n Meta-Analysis:</p>\n<p>\n A meta-analysis that combined data from this and other similar studies suggested a 20% moderate protective benefit against symptomatic COVID-19, but the overall efficacy of HCQ/CQ in the context of available vaccines remains limited.</p>\n<p>\n  </p>\n<p>\n Recommendations</p>\n<p>\n While HCQ/CQ showed modest efficacy in preventing symptomatic COVID-19, it is unlikely to be recommended for widespread use due to the availability of vaccines, which provide more robust protection. However, the findings may still hold value in situations where vaccines are unavailable or in future pandemic scenarios.</p>\n<p>\n  </p>\n<p>\n Conclusion</p>\n<p>\n The COPCOV trial demonstrated that HCQ and CQ are safe, with moderate protection against symptomatic COVID-19. However, in the context of evolving COVID-19 prevention strategies, particularly with vaccine development, these drugs are not expected to play a major role. Nonetheless, the trial highlights the importance of conducting large-scale randomized controlled trials during pandemics to provide clear evidence for treatment and prevention approaches.</p>\n
      • implication_results<p data-pm-slice=\"1 1 []\">\n The results of the COPCOV trial have several implications for current medical and public health practice, especially concerning the use of hydroxychloroquine (HCQ) and chloroquine (CQ) for COVID-19 prevention:</p>\n<p>\n  </p>\n<p>\n 1. Limited Role for HCQ/CQ in Current COVID-19 Prophylaxis</p>\n<p>\n Vaccine Priority: With the development and widespread availability of highly effective COVID-19 vaccines, HCQ/CQ are no longer considered viable prophylactic options. The trial demonstrated moderate efficacy in reducing symptomatic cases (15%), but vaccines provide much higher levels of protection (up to 90% efficacy) and are now the preferred preventive measure.</p>\n<p>\n No Impact on Asymptomatic Cases: The trial showed no significant effect on asymptomatic infections, further limiting the utility of HCQ/CQ as preventive tools.</p>\n<p>\n 2. Future Pandemic Preparedness</p>\n<p>\n Exploration of Early Pandemic Treatments: Although HCQ/CQ are unlikely to be used for COVID-19 prevention in the current pandemic, their moderate efficacy and safety profile suggest they could be explored in future pandemics, especially in the early stages before vaccines are available. This underscores the importance of maintaining a pipeline of potential treatments for rapid deployment.</p>\n<p>\n 3. Emphasis on Evidence-Based Practices</p>\n<p>\n Importance of Randomized Trials: The COPCOV trial reinforced the necessity of conducting large-scale, randomized controlled trials (RCTs) to determine the efficacy of potential treatments. Early in the pandemic, HCQ was widely used based on limited evidence, leading to controversy and mixed outcomes. This study serves as a reminder that high-quality evidence must guide clinical practice to avoid unnecessary or ineffective treatments.</p>\n<p>\n 4. Healthcare Worker Safety</p>\n<p>\n Protection Through Vaccination and Other Measures: Although the trial did not provide conclusive evidence for the continued use of HCQ/CQ, it highlighted the need for adequate protection for healthcare workers. Vaccines, personal protective equipment (PPE), and infection control practices remain the primary strategies for protecting healthcare workers, rather than chemoprevention.</p>\n<p>\n 5. Reallocating Research Focus</p>\n<p>\n Shift to Vaccine-Based Solutions: The COPCOV trial’s findings signal a shift in focus from drug-based prevention (like HCQ/CQ) to vaccine-driven solutions. This emphasizes the importance of supporting vaccine development and distribution as the most effective way to manage pandemics.</p>\n<p>\n In summary, while the COPCOV trial confirmed the safety and moderate efficacy of HCQ/CQ, their role in preventing COVID-19 is minimal in the current context of vaccine availability. The findings reinforce the need for evidence-based interventions and could inform preparedness for future infectious disease outbreaks.</p>\n
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      • modified2024-10-02 11:34:11
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        • family_nameEtyang
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        • professional_addressKEMRI Wellcome Trust Research Programme, P O Box 230, 80108 Kilifi
        • telephone0722417507
        • emailAEtyang@kemri-wellcome.org
        • created2020-05-02 09:41:01
        • modified2021-12-19 15:56:05
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          • created2012-05-31 16:15:49
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          • created2012-06-15 10:27:02
          • modified2012-06-15 10:27:02
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        • sponsorUniversity of Oxford
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        • contact_personDr, William Schilling
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        • telephone_number+447555397128
        • fax_number
        • cell_number+447555397128
        • email_addresswilliam@tropmedres.ac
        • created2020-05-02 09:41:01
        • modified2021-12-19 15:56:05
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