drugset / Trial / NCT05004753

A Study to Evaluate the Safety and Efficacy of Artemisinin- a Herbal Supplement on COVID-19 Subjects

NCT05004753

RandomizedParallel-groupOpen-labelTreatment

Summary

This will be an open label, prospective, multi-center, comparative, interventional study to evaluate safety and efficacy of Artemisinin 500 mg in subjects with mild to moderate COVID-19. Initially subjects having mild to moderate COVID-19 will be screened as per predefined eligibility criteria for the study. Eligible 120 subjects will be enrolled to receive treatment with Artemisinin and SOC (Standard of Care as per CLINICAL MANAGEMENT PROTOCOL: COVID-19, Government of India Ministry of Health and Family Welfare Directorate General of Health Services (EMR Division)) or SOC. Subjects will be randomized in 2:1 ratio. Group 1 will have 80 subjects and Group 2 will have 40 subjects.

Timeline

Start
2020-09-30
Primary completion
2021-02-28
Completion
2021-04-30

Publications

  • Results Trieu V, Saund S, Rahate PV, Barge VB, Nalk KS, Windlass H, Uckun FM. Targeting TGF-beta pathway with COVID-19 Drug Candidate ARTIVeda/PulmoHeal Accelerates Recovery from Mild-Moderate COVID-19. Clinical Investigation (2021) 11(1), 10-18

Drugs

EvaluationDrugModalityDoseRoute
Subject Artemisinin Small molecule 500 mg
Comparator Dexamethasone Small molecule

Indications