Phytomedicines Versus Hydroxychloroquine as an Add on Therapy to Azythromycin in Asymptomatic Covid-19 Patients (PHYTCOVID-19)

Institute for Research and Development of Medicinal and Food Plants of Guinea

Status and phase: Unknown; Phase 2

Conditions: Covid19

Treatments: Combination Product: Quinquina-Stevia/Azythromycin; Combination Product: 4Plants/Azythromycin; Combination Product: Hydroxychloroquine/Azithromycine

Study type: Interventional

Funder types: Other

Identifiers

NCT04501965

IRDPMAG

Details and patient eligibility

About

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

Full 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.

Enrollment: 231 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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231 participants in 3 patient groups

Hydroxychloroquine/Azythromycin

Active Comparator group

Description:

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

Treatment:

Combination Product: Hydroxychloroquine/Azithromycine

Quinquina/Azythromycin

Experimental group

Description:

Patients receive 3.5g tea bags of Cinchona/Stevia powder orally at the rate of 3 tea bags per day for 10 days

Treatment:

Combination Product: Quinquina-Stevia/Azythromycin

4plants/Azythromycin

Experimental group

Description:

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

Treatment:

Combination Product: 4Plants/Azythromycin