drugset / Trial / NCT04501965

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

NCT04501965

RandomizedParallel-groupOpen-labelTreatment

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

Timeline

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

Publications

Drugs

EvaluationDrugModalityDoseRoute
Subject 4Plants Unknown 3.5 g Oral
Subject Hydroxychloroquine Small molecule 200 mg Oral
Subject Quinquina-Stevia Unknown 3.5 g Oral
Background 4Plants/Azythromycin Unknown 250 mg Oral
Background Azithromycin Small molecule 250 mg Oral
Background Quinquina-Stevia/Azythromycin Unknown 250 mg Oral

Indications