Pan African Clinical Trials Registry

South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: www.pactr.org
Trial no.: PACTR202010537777617 Date of Approval: 15/10/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title FLAVOCOV Distributed Clinical Trial. COVID-19
Official scientific title Efficacy and Safety of select Flavonoids for the Treatment of Uncomplicated SARS-CoV-2 COVID-19
Brief summary describing the background and objectives of the trial 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.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) FLAVOCOV
Disease(s) or condition(s) being studied Respiratory
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 01/11/2020
Actual trial start date
Anticipated date of last follow up 31/01/2021
Actual Last follow-up date
Anticipated target sample size (number of participants) 200
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL https://www.sciencedirect.com/science/article/pii/S030698772031358X
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Stratified allocation where factors such as age, gender, center, or previous treatment are used in the stratification Central randomisation by phone/fax Masking/blinding used Care giver/Provider,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
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
Control Group Placebo Control group 2000mg placebo (taken without meals) per day. 30 days Placebo 100 Placebo
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
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Patients 18-80 y.o.presenting with positive PCR test for COVID-19. Patients on chronic medications that require P450 enzyme to be uninhibited. (example - atorvastatin, blood thinners, heart arrhythmia medication) Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 80 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
No 23/10/2020 Scientific and Ethics Board
Ethics Committee Address
Street address City Postal code Country
Mbagathi Rd Nairobi 00100 Kenya
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Days from patient presentation to negative nasopharyngeal PCR result Every 3 days excl Sundays - example monday, thursday, monday thursday
Secondary Outcome Count of viral RNA copies via qPCR or digital PCR Every 3 days excl Sundays - example Monday, Thursday, Monday, Thursday
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
EMSKE Phytochem designated recruitment centre Temporary - Kitale Ln off Denniss Pritt Nairobi 00100 Kenya
FUNDING SOURCES
Name of source Street address City Postal code Country
EMKSE Phytochem and Thermosystems EA JV Purple Haze Estate 5th floor Ste 508, Kitale Ln off Dennis Pritt Rd, Kilimani Nairobi Kenya
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor EMSKE Phytochem Purple Haze, 5th floor Ste 508, Kitale Ln, off Dennis Pritt, Nairobi Nairobi 00100 Kenya Commercial Sector/Industry
Secondary Sponsor Thermosystems EA The Green House, 3rd floor, East Wing, Suite 14 Ngong Road Nairobi 00100 Kenya Commercial Sector/Industry
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Scientific Enquiries Rick Sheridan rick@emske-phytochem.com +254713574371 Kitale Ln
City Postal code Country Position/Affiliation
Nairobi Kenya CEO
Role Name Email Phone Street address
Principal Investigator Willie Nyambati wnyambati@gmail.com +254722517250 Thermosystems EA, The Green House, 3rd floor, East Wing, Suite 14 Ngong Road
City Postal code Country Position/Affiliation
Nairobi 00100 Kenya Chief Scientific Officer
Role Name Email Phone Street address
Public Enquiries Leah Kigondu leah@emske-phytochem.com +254708294132 Purple Haze 5th floor Ste 508
City Postal code Country Position/Affiliation
Nairobi 00100 Kenya Program Manager
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes The sharing of deidentified individual participant data is an ethical obligation of all participating clinical trial sites. Informed Consent Form,Study Protocol Results by Jan 1 2021. Availability window for 2 years following. Trial early results limited to clinical trial site-level participants
URL Results Available Results Summary Result Posting Date First Journal Publication Date
https://www.emske-phytochem.com No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Public title 12/10/2020 edit FLAVOCOV Distributed Clinical Trial FLAVOCOV Distributed Clinical Trial. COVID-19
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Official scientific title 12/10/2020 edit 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
Section Name Field Name Date Reason Old Value Updated Value
Funding Source FundingSources List 14/10/2020 Clarifying per PACTR feedback EMKSE Phytochem and Thermosystems EA JV, Purple Haze Estate 5th floor Ste 508, Kitale Ln off Dennis Pritt Rd, Kilimani, Nairobi, , Kenya, Self Funded,
Section Name Field Name Date Reason Old Value Updated Value
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,
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 14/10/2020 Clarifying as per PACTR feedback Control Group, Placebo Control group, 2000mg placebo (taken without meals) per day., 30 days, Placebo, 100, Placebo
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 14/10/2020 Clarifyin 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, 100,
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 14/10/2020 Adding dose-dependence verification capability to trial arms. 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,
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 14/10/2020 Clarifying 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,
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 14/10/2020 Clarifying as per PACTR feedback. 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,
Section Name Field Name Date Reason Old Value Updated Value
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,
Section Name Field Name Date Reason Old Value Updated Value
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. 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.
Section Name Field Name Date Reason Old Value Updated Value
Collaborators Collaborators List 22/10/2020 Not yet media-ready for public disclosure. KEMRI, Mbagathi Rd, Nairobi, , Kenya
Section Name Field Name Date Reason Old Value Updated Value
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,
Section Name Field Name Date Reason Old Value Updated Value
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