A Phase 2 interventional study of Hydroxychloroquine/Azithromycine and Quinquina-Stevia/Azythromycin in Covid19, sponsored by Institute for Research and Development of Medicinal and Food Plants of Guinea. Status unknown at 1 site in Guinea. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-08-07.
Sponsored by Institute for Research and Development of Medicinal and Food Plants of Guinea · Phase 2, Interventional, and Treatment
Our previous work on plants has indicated significant antimalarial and antiviral activities. Of these plants, two recipes are proposed for evaluation for COVID-19. It is Cinchona, an antimalarial and a combination of 4 plants with antiviral, antimalarial, antitussive and anti-inflammatory properties.
The phase II clinical trial, with three arms and at a rate of 77 patients per arm, received the approval of the National Committee for Ethics and Health Research. This is a non-inferiority test aimed at comparing the therapeutic impact in "add on" to Azithromycin, phytomedicines versus Hydroxychloroquine in asymptomatic COVID-19 patients.
After 10 days of treatment, viral clearance and symptom progression will be assessed on days 3, 6 and 14. Clinical, paraclinical and laboratory tests will be performed throughout the 3-month trial. Ethical and deontological considerations will be applied
All consenting subjects who meet the inclusion criteria will benefit from an individual file which will include data relating to general information, the complete clinical examination and the paraclinical examination. They are distributed randomly into three parallel groups, each arm having a different treatment modality. A balanced randomization by permutation block of 5 will be applied using the "Randomizer for Clinical Trial" application developed by the company Medsharing). Laboratory examinations are carried out according to the procedures and method by laboratories accredited in Guinea for the diagnosis of COVID19. Data is encoded, entered and processed using statistical software.
The comparison between the three cohorts will be made using either the Anova test for continuous variables or the chi-square test for categorical variables. The rate of change over time of virologic clearance, fever and other symptoms values as well as the differences for these rates between treatment arms will be tested using mixed-effects modeling.
The biological samples will be stored at the biobank of the National Institute of Public Health of Guinea.
Exclusion Criteria:
Patients received Hydroxychloroquine 200 mg tablet orally 3 times daily for 10 days and Azythromycine 250 mg orally at the rate of 2 tablets the first day, then one tablet for 5 days
Combination Product: Hydroxychloroquine/Azithromycine
Patients receive 3.5g tea bags of Cinchona/Stevia powder orally at the rate of 3 tea bags per day for 10 days
Combination Product: Quinquina-Stevia/Azythromycin
Participants received 4Plants powder in a 3.5g tea bag orally three times daily for 10 days and Azythromycine 250 mg orally at the rate of 2 tablets the first day, then one tablet for 5 days
Combination Product: 4Plants/Azythromycin
Dual treatment with Hydroxychloroquine and Azythromycin
Dual treatment with Quinquina/Stevia (3/0,5) and Azythromycin
Also known as: CILE
Dual treatment with 4 plant species drug and Azythromycin
Also known as: ACAR
Virologic clearance of throat swabs or lower respiratory tract secretions
Virologic clearance from admission to discharge at days 3, 6 and 14
Time frame: day 3 to day 14
COVID-19 symptoms development
number of patients who developed fever, cough, and any other clinical sign typical of the disease
Time frame: day 1 to day 14
Adverse effects
number of participants who developed treatment-related adverse effects
Time frame: day 1 to day 14
Worsened condition
number of patients whose condition worsened on D14
Time frame: day 1 to day 14
Plan to share: Yes — The samples stored in the biobank could be shared with other researchers with a view to in-depth analyzes in order to dig for example a posteriori on the hypotheses relating to the blood levels of the phytomedicine, hydroxychloroquine, etc., cardio-metabolic biological markers infarction, insulin sensitivity, thrombosis, specific antibodies, genetic markers, viral markers ...
Supporting information: Study protocol, Sap, Icf, Csr
This study is status unknown, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.
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Institute for Research and Development of Medicinal and Food Plants of Guinea