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: pactr.samrc.ac.za
Trial no.: PACTR202210816121866 Date of Registration: 27/10/2022
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Herbal preparation for the treatment of COVID-19: Randomized clinical trial to test the safety and efficacy on the viral clearance of SARS-CoV-2
Official scientific title Herbal preparation for the treatment of COVID-19: Randomized clinical trial to test the safety and efficacy on the viral clearance of SARS-CoV-2
Brief summary describing the background and objectives of the trial The SARS-CoV-2 pandemic has demonstrated the lack of drugs for the treatment and prevention of the disease. Older molecules such as chloroquine or antibiotics are used to prevent bacterial superinfection during viral infections. Initiatives are emerging everywhere to find a rapid and appropriate response to this global pandemic. Natural resources, especially our pharmacopoeias, are full of therapeutic and preventive properties on which we can hope to find remedies to limit the effects of this virus. Most of our plants currently in use constitute major recipes of several pharmacopoeias and continue to treat our populations. Our endogenous plants have been consumed for several generations, their use is an indication of low toxicity. Plants like Zingiber and hibiscus are currently used in food. For example, Artemisia has been used for centuries in China. Thus, at a time when each country is exploring all medical scientific and technical means to contain the pandemic, countries with limited resources such as Mali. In the perspective of providing an adapted therapeutic response, but also with the aim of our contribution to the revalorization of traditional medicine, we have undertaken trials to formulate undertaken formulation trials of improved traditional medicine preparations. The objective of this study is to test the preparation or formulation of the pharmacopoeia on the viral clearance during SARS-CoV-2 infection and the prevention of severe signs of the disease seen in the Hospital of Mali (Bamako, Mali).
Type of trial RCT
Acronym (If the trial has an acronym then please provide) KAFO TRIAL
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 31/10/2022
Actual trial start date 08/11/2022
Anticipated date of last follow up 31/01/2023
Actual Last follow-up date 28/02/2023
Anticipated target sample size (number of participants) 120
Actual target sample size (number of participants) 120
Recruitment status Active, not recruiting
Publication URL
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 Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group COMARUS COMARUS syrup: 80 ml three times a day (morning, noon and evening) after having eating well during seven (07) days 07 days Intervention group: COMARUS SYRUP will be administered as follow 80 ml three times a day (morning, noon and evening) after having eating well in randomized hospitalized patients by the study pharmacist and the clinical monitoring will be performed by the blinded clinicians during the 10 days of hospitalization. 60
Control Group National treatment Group Hydroxichloroquin 500 mg, 2 tablets per day for 5 days; Azithromycin 500 mg for the first day and 250 mg for 4 days; Vitamin C for 7 days 07 days The control group will receive Hydroxichloroquin 500 mg, 2 tablets per day for 5 days; Azithromycin 500 mg for the first day and 250 mg for 4 days, Vitamin C for 7 days in randomized hospitalized patients by the study pharmacist. The clinical monitoring will be performed by the blinded clinicians during the 10 days of hospitalization. 60 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Presence of SARS-CoV-2 Respiratory rate (RR) 10-30/min PaO2/FiO2 > 300 mmHg SatO2 >95% in AA No organ failure Patients who did not have a follow-up laboratory test Patients with symptoms classified as severe to critical, Patients with hepatic, renal and/or hematological laboratory disturbances hematological disturbances. Severe case at least one of the following signs Respiratory rate (RR) > 30/min ; SatO2 <93% in AA PaO2/FiO2 < 300 mmHg No organ failure Critical at least one of the signs Respiratory distress requiring mechanical ventilation Multi-organ failure Shock Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year 18 Year(s) 35 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
Yes 24/10/2022 Ethics Committee of the USTTB
Ethics Committee Address
Street address City Postal code Country
Point G Bamako 1805 Mali
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Doses will be considered non-toxic when the values obtained for the biochemical and hematological parameters are comparable before and after dosing in uninfected subjects with SARS-CoV-2 without signs of Covid-19. The intervention is effective when the time of clearance of the viral load obtained by the administration of different doses of the COMARUS Syrup is comparable with the clearance time obtained with the national treatment scheme Day 3, Day 06, Day 09 and Day 10
Secondary Outcome The intervention is effective when patients do not develop develop severe signs of the disease and no longer carry SARS-CoV-2 by the negativation of 2 successive tests by real-time PCR in comparison with the national treatment protocol Day 06 and Day 09
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Hospital Mali Missabougou, Commune 6 Bamako BP 3333 Mali
FUNDING SOURCES
Name of source Street address City Postal code Country
Ministry of Health Cite administrative Bamako BP 232 Mali
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Faculty of Pharmacy Point G, Commune 3 Bamako 1805 Mali University
COLLABORATORS
Name Street address City Postal code Country
Alhousseyni Breteaudeau National Academy of Science, Bamako Bamako Mali
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Garan DABO garan.dabo@lbma.edu.ml 0022373938843 Hospital Mali
City Postal code Country Position/Affiliation
Bamako 3333 Mali Professor of Infectious diseases and Faculty of Medicine
Role Name Email Phone Street address
Public Enquiries Sekou Oumar DEMBELE dembele_sekou@yahoo.fr 00223760209 Cite administrative, Ministry of Health
City Postal code Country Position/Affiliation
Bamako BP 232 Mali Advisor in the Ministry of Health
Role Name Email Phone Street address
Scientific Enquiries Ousmane KOITA ousmane.koita@lbma.edu.ml 0022366749312 Campus universitaire de Badalabougou
City Postal code Country Position/Affiliation
Bamako BPE 3206 Mali Professor of Molecular Biology at the Faculty of Pharmacy
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All of the individual participant data collected during the trial will be shared Analytic Code,Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol During the trial and immediately following publication Researchers who provide a methodologically sound proposal
URL Results Available Results Summary Result Posting Date First Journal Publication Date
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