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.: PACTR202009483194545 Date of Approval: 21/09/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Evaluation of phytopharmaceuticals to improve the prognosis of Covid-19 disease in Togo.
Official scientific title Evaluation of phytopharmaceuticals to improve the prognosis of Covid-19 disease in Togo.
Brief summary describing the background and objectives of the trial SARS-CoV-2 infection is a global health problem. Due to a rapidly evolving epidemiology and an overall case-fatality of 2-5% to date, specific and rapid treatment is necessary to limit the spread of the disease but also to reduce morbidity and mortality. Despite the numerous clinical trials in progress, no molecule has formally demonstrated its activity during Covid-19 infection. The early management of patients through isolation and treatment to prevent complications related to the infection and the spread of the virus is a major issue. Hydroxychloroquine (HCQ), which could have both an antiviral and an immunomodulatory effect, is a known and accessible drug, while the others, two protease inhibitors coupled with ritonavir (PI/r) - lopinavir (LPV) and darunavir (DRV) - have been used for many years in human immunodeficiency virus (HIV) infection. The availability of the latter two molecules is limited in Togo. Hydroxychloroquine was therefore until now one of the serious candidates for treatment. This molecule, used in Togo for the treatment of confirmed cases of Covid-19, is now being questioned due to contradictory clinical data. Consequently, the current trend is to look for an endogenous solution. The World Health Organization has stated that it supports all efforts to find a local treatment in accordance with the rules of scientific research. • The main objective of this trial is to evaluate the efficacy of four Togolese phyto-medicines (IMMU-TOP®, IMMUNITUM®, SECURE®, BIOCIRE®) in reducing the duration of SARS-CoV-2 carriage in Lomé, Togo. Secondly, it will involve to: - Describe the clinical evolution of persons hospitalized for Covid-19 and treated with phyto-medications. - Describe the time of hospital discharge between the different strategies of phyto-medication. - Describe the 8-day and 4-week mortality in the different phyto-medication groups - Describe the proportion of people who have died or have respiratory distress syndrome in the different
Type of trial RCT
Acronym (If the trial has an acronym then please provide) PHYTO CoV
Disease(s) or condition(s) being studied Infections and Infestations
Sub-Disease(s) or condition(s) being studied SARS-CoV-2 Infection
Purpose of the trial Treatment: Drugs
Anticipated trial start date 15/10/2020
Actual trial start date
Anticipated date of last follow up 30/03/2021
Actual Last follow-up date
Anticipated target sample size (number of participants) 250
Actual target sample size (number of participants)
Recruitment status 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 Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group IMMUTOP 2 caps three times a day 10 days Immu-Top gathers the following whole mushrooms and mycelia: - Agaricus Blazei Murril (ABM) - Grifola frondosa - Reishi-Ganoderma Lucidum Effects - Activation of the body's defenses, stimulation of antibody production - Limitation of the effects of oxidative stress and free radicals - Effect against asthma, chronic bronchitis, cough and shortness of breath, suffocation through the action of reichi - Reishi is very effective against chronic airway diseases that affect oxygenation, as it improves oxygen saturation 50
Experimental Group IMMUNITUM 1 caps twice a day 10 days Imunitum is an immunity booster drug. It is a multivitamin complex containing extracts of plants with therapeutic virtues including Cicer arietinum and Porphyra Umbilicalis which is an algae of the genus Porphyra. Other effects: antioxidants, antidiabetics, anti-inflammatory drugs. 50
Experimental Group SECURE 36 ml of pure product per day 10 days SECURE is an extract of Securidaca longipedunculata, it contains more than 90% methyl salicylate (analgesic substance). The medicinal applications of the roots of the plant are mainly: the treatment of pain; the fight against eczema, allergic dermatitis, pruritus; the treatment of anemia. 50
Experimental Group BIOCIRE 02 Madeira glasses three times a day 10 days BIOCIRE contains momordica balsamina and Xylopia aethiopica with anti-HIV, antimicrobial (antibacterial, antiviral), and anti-inflammatory properties. The therapeutic agent "Momordine" is capable of inhibiting the growth of HIV and other viruses. Important source of nutrients containing 17 amino acids and high potassium content. 50
Control Group Hydroxychloroquine and Azithromycine Hydroxychloroquine 600 mg daily for 07 days Azithromycin 250 mg/day for 5 days Hydroxychloroquine: 07 days Azithromycin: 05 days In vitro studies in China have demonstrated the efficacy of hydroxychloroquine on CoV-2-SARS in addition to its immunomodulatory activity. Several clinical trials, notably in France and China, have reported beneficial effects in the treatment of CoV-2-SARS infection. stronger effects have been reported when chloroquine is combined with a macrolide antibiotic such as azithromycin. Possible side effects, especially a prolongation of the QTc interval, which can cause heart rhythm disorders, have been reported. 50 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
- Patients over 18 years of age. - Infected with a Covid-19 infection confirmed by a specific PCR. - Hospitalized. - Fever or cough - No signs of respiratory distress - Naïve of specific treatment for Covid-19. - Informed consent signed by the patient. - Renal insufficiency (eGFR <30 ml/min, CKD-EPI formula). - AST or ALT > 3 times normal - Cirrhosis (stage ≥ Child-Pugh B). - Pregnancy or breastfeeding. - Dementia or any other condition that does not allow for informed consent. - Any reason that, at the discretion of the investigator, would compromise patient safety and cooperation in the trial. 80 and over: 80+ Year,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
Yes 23/06/2020 Health Research Bioethics Committee
Ethics Committee Address
Street address City Postal code Country
Ministry of Health, Directorate of Pharmacies, Angle avenue Sarakawa and avenue of february 2 Lome 00228 Togo
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Proportion of patients with undetectable viral load Day 8 post inclusion
Secondary Outcome Proportion of patients with clinical improvement on the 7-point ordinal scale Day 8 post inclusion
Secondary Outcome Proportion of patients who died or were affected by respiratory distress syndrome Day 8 and day 28 post inclusion
Secondary Outcome Prevalence of grade 3 and 4 adverse events in each treatment group Every three days after inclusion
Secondary Outcome Proportion of patient cured Day 28 post inclusion
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Lome commune Regional Hospital Center Kegue Lome 00228 Togo
Eda Oba hotel Gnassingbe Eyadema Boulevard Lome 00228 Togo
LeBenin hotel Avenue du general de Gaulle Lome 00228 Togo
FUNDING SOURCES
Name of source Street address City Postal code Country
University of Lome 01BP1515 Adewui Lome 00228 Togo
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor University of Lome 01BP1515, Adewui Lome 00228 Togo University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator DAGNRA Claver claverdagnra@gmail.com +22890015656 01BP1515, Adewui
City Postal code Country Position/Affiliation
Lome 00228 Togo MD Professor of Bacteriology and Virology at the University of Lome and head of the Bacteriology and Virology Department at Sylvanus Olympio University Hospital
Role Name Email Phone Street address
Principal Investigator Ihou WATEBA Mageste majeste7@yahoo.fr +22870259186 01BP1515, Adewui
City Postal code Country Position/Affiliation
Lome 00228 Togo MD Professor of Infectious Diseases at the University of Lome and Head of the Department of Infectious Diseases CHU Sylvanus Olympio
Role Name Email Phone Street address
Scientific Enquiries ADJOH Seraphin komiadjoh@yahoo.fr +22892405968 01BP1515, Adewui
City Postal code Country Position/Affiliation
Lome 00228 Togo MD Professor of PneumoPhthysiology at the University of Lome and Head of the Department of PneumoPhthysiology at Sylvanus Olympio University Hospital.
Role Name Email Phone Street address
Scientific Enquiries SALOU Mounerou mounerous@gmail.com +22893475989 01BP1515, Adewui
City Postal code Country Position/Affiliation
Lome 00228 Togo PharmD PhD Professor of Bacteriology and Virology at the University of Lome and Head of Laboratories at the Campus University Hospital of Lome
Role Name Email Phone Street address
Scientific Enquiries EKOUEVI Didier Koumavi didier.ekouevi@gmail.com +22899686735 89 rue des sarrasins
City Postal code Country Position/Affiliation
Lome 00228 Togo MD PhD Professor of Public Health and Epidemiology at the University of Lome and Head of the Department of Public Health in the Faculty of Health Sciences
Role Name Email Phone Street address
Public Enquiries KOKOU Kouami kokoukouami@wascal-togo.org +22890020411 01BP1515, Adewui
City Postal code Country Position/Affiliation
Lome 00228 Togo Director of the Master Research Program University lecturer of ecology and forest natural resources management
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All participant information will be kept strictly confidential. Information such as the name of the participant or any other data that could lead to the identification of the participant will not be recorded in the trial database. All paper documents and electronic files necessary for data management will be restricted to authorized study personnel, both internationally and locally. The trial database will be accessible only by means of a personal username and password. A list of authorized users of the database will be maintained by the Methodology and Management Centre and updated during the study. Informed Consent Form,Study Protocol 2 years Any project for the use of data and/or biological samples from the trial not included in the protocol and any project for a complementary study, whether it comes from members of the scientific council or from external investigators, must be submitted in writing to the scientific council which will give an opinion on the scientific, ethical and technical aspects, before submitting it to the University of Lome which will have to give its agreement for its implementation. These projects must receive the favorable opinion of the ethics committees of the countries concerned. After the dissolution of the scientific council, the use of the data and the biotheque will be subject to the rules defined by the University of Lome.
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