NCT05004753

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

A Prospective, Randomized, Multi-center, Open Label, Interventional Study to Evaluate the Safety and Efficacy of Artemisinin 500 mg Capsule in Treatment of Adult Subjects With COVID-19

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Mateon Therapeutics · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The study will involve screening (Day 1), treatment period of up to maximum 28 days till end of study. The investigator shall make every effort to follow the schedule of study assessments and procedures. A window period of 1 day will be allowed for assessments post randomization. Screening Upon obtaining the written informed consent the subjects will be screened to confirm the eligibility for participating in this study. If RT PCR result is available for the subject then screening and baseline (randomization) activity will be on the same day. As per the Investigator discretion, the subjects meeting the criteria will be hospitalized for the first cycle of treatment Treatment period Subjects will receive investigational product and SOC after randomization as per protocol. Subject's compliance with the study treatment regimen of Artemisinin one (1) capsule a day for five (5) days, will be assessed during treatment period. Subjects receiving at least one dose of study treatment will be included in the safety analysis. Efficacy analysis will be conducted in completers (subjects who have completed at least 5 consecutive days of dosing in either arm) The first cycle of the study drug treatment will be given in the hospital, for which the subjects have to be hospitalized till Day 5, unless prolongation of hospital stay is necessary as per the investigator. On day 14, telephonic follow up is done for subjects discharged after Day 5. For Day 28 visit all subjects will visit the hospital to complete the End of Study activities.

Conditions

• Covid19

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Artemisinin	a herbal supplement
DRUG	Dexamethasone	corticosteroids

Timeline

• Start date: 2020-09-30
• Primary completion: 2021-02-28
• Completion: 2021-04-30
• First posted: 2021-08-13
• Last updated: 2021-09-09

Locations

3 sites across 1 country: India