MedTrace Logo

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

NCT05004753 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2021-09-09

No results posted yet for this study

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.

Conditions

  • Covid19

Interventions

DIETARY_SUPPLEMENT

Artemisinin

a herbal supplement

DRUG

Dexamethasone

corticosteroids

Sponsors & Collaborators

  • Windlas Biotech Private Limited

    collaborator UNKNOWN

  • Mateon Therapeutics

    lead INDUSTRY

Principal Investigators

  • Mukesh Kumar · Windlas Biotech Private Limited

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • India

Study Locations

More Related Trials

Entities

Drugs

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 NCT05004753 on ClinicalTrials.gov