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Trial Information |
Public title |
12/10/2020 |
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FLAVOCOV Distributed Clinical Trial |
FLAVOCOV Distributed Clinical Trial. COVID-19 |
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Official scientific title |
12/10/2020 |
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Efficacy and safety of name of antiviral drug(s) or drug combination(s) for the treatment of uncomplicated SARS-CoV-2 COVID-19 |
Efficacy and Safety of select Flavonoids for the Treatment of Uncomplicated SARS-CoV-2 COVID-19 |
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Funding Source |
FundingSources List |
14/10/2020 |
Clarifying per PACTR feedback |
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EMKSE Phytochem and Thermosystems EA JV, Purple Haze Estate 5th floor Ste 508, Kitale Ln off Dennis Pritt Rd, Kilimani, Nairobi, , Kenya, Self Funded, |
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Intervention |
Intervention List |
14/10/2020 |
Clarifying as per PACTR feedback |
Experimental Group, Experimental, 2000 mg (taken without meals) per day, 30 days, 90% Diosmin, 10% Hesperidin, 100, |
Experimental Group, Experimental pharmaceutical preparation flavonoids intervention, 2000 mg (taken without meals) per day, 30 days, 90% Diosmin, 10% Hesperidin, 100, |
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Intervention List |
14/10/2020 |
Clarifying as per PACTR feedback |
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Control Group, Placebo Control group, 2000mg placebo (taken without meals) per day., 30 days, Placebo, 100, Placebo |
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Intervention List |
14/10/2020 |
Clarifyin as per PACTR feedback |
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Experimental Group, Experimental pharmaceutical preparation flavonoids intervention 2000mg daily, 2000 mg (taken without meals) per day, 30 days, 90% Diosmin, 10% Hesperidin, 100, |
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Intervention List |
14/10/2020 |
Adding dose-dependence verification capability to trial arms. |
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Experimental Group, Experimental pharmaceutical preparation of micronized flavonoids. Dose dependence verif. 1500mg, 1500 mg of micronized 90% diosmin, 10% hesperidin, daily without meals., 28 days - option to extend to 35 days as site resources permit., This arm aims to highlight dose-dependent characteristics of the intervention. 1500 mg / day is expected to be therapeutic but to showing a reduced signal at the endpoint than 2000 mg / day, 50, |
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Intervention List |
14/10/2020 |
Clarifying per PACTR feedback |
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Experimental Group, Experimental pharmaceutical preparation flavonoids intervention 2000mg daily, 2000 mg (taken without meals) per day, 30 days, 90% Diosmin, 10% Hesperidin. Available as off the shelf pharmaceutical in most sub-Saharan African countries., 100, |
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Intervention |
Intervention List |
14/10/2020 |
Clarifying as per PACTR feedback. |
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Experimental Group, Experimental pharmaceutical preparation of micronized flavonoids. Dose dependence verif. 1500mg, 1500 mg of micronized 90% diosmin, 10% hesperidin, daily without meals., 28 days - option to extend to 35 days as site resources permit., This arm aims to highlight dose-dependent characteristics of the 90% Diosmin 10% hesperidin intervention. 1500 mg / day is expected to be therapeutic but to showing a reduced signal at the endpoint than 2000 mg / day, 50, |
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Intervention |
Intervention List |
14/10/2020 |
Clarifying as per PACTR feedback |
Experimental Group, Experimental pharmaceutical preparation flavonoids intervention 2000mg daily, 2000 mg (taken without meals) per day, 30 days, 90% Diosmin, 10% Hesperidin. Available as off the shelf pharmaceutical in most sub-Saharan African countries., 100, |
Experimental Group, Experimental pharmaceutical preparation micronized flavonoids intervention 2000mg daily, 2000 mg (taken without meals) of pharmaceutical preparation of micronized 90% diosmin 10% hesperidin per day, 30 days, micronized 90% diosmin, 10% hesperidin. Available as off the shelf pharmaceutical in most sub-Saharan African countries., 100, |
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Trial Information |
Trial description |
15/10/2020 |
edit |
Purpose: To assess the efficacy of plant-derived compounds showing antiviral activity to support updating of international standard-of-care policy;
Objective: To assess the efficacy and safety of select flavonoids for the treatment of uncomplicated SARS-CoV-2 COVID-19 infections.
Study Sites: Participating clinical trial sites in Africa capable of contributing uncomplicated C19-positive caseload to the study. Inside and outside Kenya: micronized 90% diosmin 10% hesperidin formulation.
Inside Kenya: Registration to be updated subsequently with Kenya supply-chain specific intervention.
Sample Size: 40 patients per site for 5 sites
Treatment(s) and follow-up: Clinical and virological parameters will be monitored over a 30-day follow-up period to evaluate drug efficacy of daily administered 2000mg of 90% diosmin 10% hesperidin.
Primary endpoints: The proportion of patients with early treatment failure, late clinical failure, late virological failure or an adequate clinical and virological response as indicators of efficacy.
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Purpose: To assess the efficacy of plant-derived compounds showing antiviral activity to support updating of international standard-of-care policy;
Objective: To assess the efficacy and safety of select flavonoids for the treatment of uncomplicated SARS-CoV-2 COVID-19 infections.
Study Sites: Participating clinical trial sites in Africa capable of contributing uncomplicated C19-positive caseload to the study. Inside and outside Kenya: micronized 90% diosmin 10% hesperidin formulation.
Inside Kenya: Registration to be updated subsequently with Kenya supply-chain specific intervention.
Sample Size: 40 patients per site for 5 sites
Treatment(s) and follow-up: Clinical and virological parameters will be monitored over a 30-day follow-up period to evaluate drug efficacy of daily administered 2000mg of 90% diosmin 10% hesperidin.
Primary endpoints: The proportion of patients with early treatment failure, late clinical failure, late virological failure or an adequate clinical and virological response as indicators of efficacy.
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Collaborators |
Collaborators List |
22/10/2020 |
Not yet media-ready for public disclosure. |
KEMRI, Mbagathi Rd, Nairobi, , Kenya |
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Ethics |
Ethics List |
22/10/2020 |
Updating for correctness pending external approval on application submission |
FALSE, KEMRI Scientific and Ethics Board, Mbagathi Rd, Nairobi, 00100, Kenya, 23 Oct 2020, , +254713574371, info@emske-phytochem.com, |
FALSE, Scientific and Ethics Board, Mbagathi Rd, Nairobi, 00100, Kenya, 23 Oct 2020, , +254713574371, info@emske-phytochem.com, |
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Recruitment Centre |
RecruitmentCentre List |
22/10/2020 |
Updating to reflect accuracy pending formal approval. |
KEMRI Traditional Medicine Department, Kilimani Mbagathi Rd HOUSE NUMBER 8, Nairobi, 00100, Kenya |
EMSKE Phytochem designated recruitment centre, Temporary - Kitale Ln off Denniss Pritt, Nairobi, 00100, Kenya |