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

NCT04501965 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 231

Last updated 2020-08-07

No results posted yet for this study

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

Conditions

  • Covid19

Interventions

COMBINATION_PRODUCT

Hydroxychloroquine/Azithromycine

Dual treatment with Hydroxychloroquine and Azythromycin

COMBINATION_PRODUCT

Quinquina-Stevia/Azythromycin

Dual treatment with Quinquina/Stevia (3/0,5) and Azythromycin

COMBINATION_PRODUCT

4Plants/Azythromycin

Dual treatment with 4 plant species drug and Azythromycin

Sponsors & Collaborators

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

    lead OTHER

Principal Investigators

  • Saliou Sow · Infectious Disease Department - Donka National Hospital Conakry Guinea

  • Mohamed Cissé · Faculté des Sciences et Techniques de Santé, Université GAN Conakry

  • Mamadou A Baldé · Institute for Research and Development of Medicinal and Food Plants of Guinea

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-01
Primary Completion
2020-08-30
Completion
2020-09-30

Countries

  • Guinea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04501965 on ClinicalTrials.gov