Phytomedicines Versus Hydroxychloroquine as an Add on Therapy to Azythromycin in Asymptomatic Covid-19 Patients
- Conditions
- Covid19
- Interventions
- Combination Product: 4Plants/AzythromycinCombination Product: Hydroxychloroquine/AzithromycineCombination Product: Quinquina-Stevia/Azythromycin
- Registration Number
- NCT04501965
- Lead Sponsor
- Institute for Research and Development of Medicinal and Food Plants of Guinea
- Brief Summary
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
- Detailed Description
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 231
- Eligible patients are adults with COVID-19 confirmed by a positive PCR (Polymerase Chain Reaction) test and without symptoms
- any patient hypersensitive to hydroxychloroquine or under traditional herbal treatment in the two weeks preceding inclusion,
- any patient with other acute or chronic illnesses such as heart failure, arterial hypertension, renal failure, hepatocellular failure, tuberculosis or unable to take the oral treatment;
- any patient for whom one of the treatments under study is contraindicated according to the doctor's opinion.
- pregnant women,
- severe neurological manifestations
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 4plants/Azythromycin 4Plants/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 Hydroxychloroquine/Azythromycin Hydroxychloroquine/Azithromycine 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 Quinquina/Azythromycin Quinquina-Stevia/Azythromycin Patients receive 3.5g tea bags of Cinchona/Stevia powder orally at the rate of 3 tea bags per day for 10 days
- Primary Outcome Measures
Name Time Method Virologic clearance of throat swabs or lower respiratory tract secretions day 3 to day 14 Virologic clearance from admission to discharge at days 3, 6 and 14
- Secondary Outcome Measures
Name Time Method Adverse effects day 1 to day 14 number of participants who developed treatment-related adverse effects
COVID-19 symptoms development day 1 to day 14 number of patients who developed fever, cough, and any other clinical sign typical of the disease
Worsened condition day 1 to day 14 number of patients whose condition worsened on D14
Trial Locations
- Locations (1)
Support Centers of Donka, Kenien and Gbessia
🇬🇳Conakry, Guinea