Covid19
Conditions
Keywords
Treatment; clinical research
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.
Interventions
COMBINATION_PRODUCTHydroxychloroquine/Azithromycine
Dual treatment with Hydroxychloroquine and Azythromycin
COMBINATION_PRODUCTQuinquina-Stevia/Azythromycin
Dual treatment with Quinquina/Stevia (3/0,5) and Azythromycin
COMBINATION_PRODUCT4Plants/Azythromycin
Dual treatment with 4 plant species drug and Azythromycin
Sponsors
Institute for Research and Development of Medicinal and Food Plants of Guinea
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Eligible consenting symptom-free patients with COVID-19 confirmed by a positive Polymerase Chain Reaction test were subjected to the 10 days of treatment allocated to each of the 3 arms of the trial. Virological clearance is assessed on days 3, 6 and 14. Side effects are noted throughout the trial period. Clinical, paraclinical and laboratory examinations are occasionally provided. Viral clearance, side effects, and the onset of COVID symptoms are evaluated and the data is statistically processed.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Eligible patients are adults with COVID-19 confirmed by a positive PCR (Polymerase Chain Reaction) test and without symptoms
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Adverse effects | day 1 to day 14 | number of participants who developed treatment-related adverse effects |
| Worsened condition | day 1 to day 14 | number of patients whose condition worsened on D14 |
Countries
Guinea
Outcome results
None listed