Clinical Trial Applications - Approved: Filter, Search, and view applications
| # | Protocol No | Study Title | Investigator(s) & Site(s) | Date Approved | |
|---|---|---|---|---|---|
301. |
21/06/16 | VAT00008 A parallel-group, Phase III, multi-stage, modified double-blind, multi-armed study to assess the efficacy, safety, and immunogenicity of two SARS-CoV-2 Adjuvanted Recombinant Protein Vaccines (monovalent and bivalent) for prevention against COVID-19 in adults 18 years of age and older |
Principal Investigator(s) 1. Fredrick Sawe Site(s) in Kenya 1. Kenya Medical Research Institute, Kisumu Clinical Reseach Site (Kisumu county) 2. KEMRI/Walter Reed Project - Clinical Research Center, Kericho (Kericho county) 3. Ganjoni Clinic - University of Washington/University of Nairobi, Mombasa (Mombasa county) 4. Partners in Health Research and Development, Thika (Kiambu county) 5. KARGENO RESEARCH AND POLICY HUB (Kisumu county) 6. The Centre for Respiratory Diseases Research (CRDR), Kenya Medical Research Institute (KEMRI) (Nairobi City county) 7. KEMRI-USAMRD-A/K, Kombewa Clinical Research Center (Kisumu county) 8. Moi University Clinical Research Centre (MUCRC), Chandaria Cancer and Chronic Diseases Center (CCCDC) (Uasin Gishu county) 9. Aga Khan University Hospital (Nairobi City county) 10. KEMRI CCR-Butere County Hospital Site (Kakamega county) |
02-08-2021 |
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302. |
ECCT/21/06/05 | VAT00008 A parallel-group, Phase III, multi-stage, modified double-blind, multi-armed study to assess the efficacy, safety, and immunogenicity of two SARS-CoV-2 Adjuvanted Recombinant Protein Vaccines (monovalent and bivalent) for prevention against COVID-19 in adults 18 years of ageand older |
Principal Investigator(s) 1. Nelly Rwamba Mugo Site(s) in Kenya KEMRI-CCR-PHRD THIKA PROJECT |
02-08-2021 |
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303. |
ECCT/21/05/03 | Adapt Out COVID Adaptive Platform Treatment trial for Outpatients with COVID-19 |
Principal Investigator(s) 1. Kawango Agot Site(s) in Kenya 1. Kenya Impact and Research Development Organization (K-IRDO) (Kisumu county) 2. KEMRI WALTER REED (Kericho county) 3. MOI UNIVERSITY CLINICAL RESEARCH CENTRE (Uasin Gishu county) 4. Kenya Medical Research Institute (Kisumu county) |
28-07-2021 |
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304. |
ECCT/20/12/02 | MERS-201 Study to Evaluate the Safety, Tolerability and Immunogenicity of INO-4700 for Middle East Respiratory Syndrome Coronavirus (MERS-CoV) in Healthy Volunteers |
Principal Investigator(s) 1. Bernhards Ogutu 2. Josphat Kosgei Site(s) in Kenya 1. Ahero Clinical Trials Unit (Kisumu county) 2. Kenya Medical Research Institute/Walter Reed Project (KEMRI/WRP) (Kericho county) |
15-07-2021 |
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305. |
ECCT/21/03/03 | PrEP My Way A Novel PrEP Delivery System to Meet the Needs of Young African Women |
Principal Investigator(s) 1. Prof. Elizabet Ann Bukusi Site(s) in Kenya Kisumu |
06-07-2021 |
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306. |
ECCT/21/02/01 | PTSD 102 TONIX A Phase 3, Double-Blind, Randomized, Multicenter, Placebo-Controlled Study to Evaluate the Efficacy and Safety of TNX-102 SL in Participants with PTSD Taken Daily at Bedtime (Protocol No. TNX-CY-P308). |
Principal Investigator(s) 1. Prof. Lukoye Atwoli Site(s) in Kenya 1. Moi Teaching and Referral Hospital/Moi University (Uasin Gishu county) 2. KEMRI Nairobi (Nairobi City county) 3. Aga Khan University Hospital (Nairobi City county) |
16-06-2021 |
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307. |
ECCT/20/12/01 | KU ‘TIBA VENT\' Phase I/II, Open Label Randomized Controlled Trial Evaluating Safety of 'KU TIBA VENT" For Mechanical Ventilation in Patients With Respiratory Failure During Weaning Phase Abstract KU TIBA VENT There is ongoing pandemic caused by SARS-Cov-2, commonly referred to us COVID-19 that started in China in December 2019. The patients develop acute respiratory failure requiring machine assisted breathing. However, due to the huge numbers affected patients, the demand for mechanical ventilators outstrip supply worldwide. This is especially so in Kenya with poor health systems. In response to the increased demand for mechanical ventilators, a group of students plus their lecturer mentors at Kenyatta University responded by designing and producing a ‘TIBA VENT” from locally available materials. The design and production processes have been evaluated by the Kenya Bureau of Standards and found to be in conformity with the countries standards. We have designed a protocol to guide clinical validation before registration by Pharmacy and Poisons Board as part of requirement for commercialization. The main objective of this clinical validation is to assess the dependability and reliability of the device when connected to patients in the intensive care Unit. The secondary end points are to assess the functionality of the control variables, the trigger settings as well as user concerns to facilitate design modifications before roll out. The clinical validation will be done at Kenyatta University Teaching, Research and Referral Hospital (KUTRRH). This is a phase II of study with expected duration of 14 days and enrolling at least 4 patients. The sponsor for the study is the Kenyatta University. The information obtained will assist in design modifications before commercialization. This is an example of homegrown innovation. |
Principal Investigator(s) 1. Gordon Oluoch Ogweno Site(s) in Kenya Kenyatta University Teaching Research and Referral Hospital (KUTRRH) |
09-06-2021 |
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308. |
ECCT/21/03/02 | PB-SAM Pancreatic Enzymes and Bile Acids: A Non-Antibiotic approach to Treat Intestinal Dysbiosis in Acutely Ill Severely Malnourished Children. |
Principal Investigator(s) 1. Robert Bandsma Site(s) in Kenya 1. Kilifi County Hospital (Kilifi county) 2. Coast General Hospital (Mombasa county) 3. Mbagathi Hospital (Nairobi City county) 4. Migori County Hospital (Migori county) |
08-06-2021 |
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309. |
ECCT/21/03/07 | CHIMES AN OPEN-LABEL, MULTICENTER STUDY TO ASSESS DISEASE ACTIVITY AND BIOMARKERS OF NEURONAL DAMAGE IN MINORITY PATIENTS WITH RELAPSING MULTIPLE SCLEROSIS RECEIVING TREATMENT WITH OCRELIZUMAB |
Principal Investigator(s) 1. Mansoor Saleh Site(s) in Kenya Aga Khan University, Nairobi |
08-06-2021 |
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310. |
ECCT/21/02/04 | GASTROSAM GASTROSAM Gastroenteritis: Rehydration of children with severe acute malnutrition |
Principal Investigator(s) 1. Professor Kathryn Maitland Site(s) in Kenya Kilifi County Hospital |
13-05-2021 |
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