A Randomised, Multi-centre, Double-blind, Phase 3 Study to Observe the Effectiveness, Safety and Tolerability of Molnupiravir Compared to Placebo Administered Orally to High-risk Adult Outpatients With Mild COVID-19 Receiving Local Standard of Care in South Africa

PHASE2/PHASE3CompletedINTERVENTIONAL
Enrollment

59

Participants

Timeline

Start Date

August 12, 2022

Primary Completion Date

July 7, 2023

Study Completion Date

September 30, 2023

Conditions
COVID-19
Interventions
DRUG

Molnupiravir 200 mg

The drug is orally bioavailable (and is indicated for treatment of mild to moderate COVID-19 in adults with a positive SARS-COV-2 diagnostic test and who have at least one risk factor for developing severe illness. The recommended dose is 800 mg (four 200 mg capsules) taken orally 12-hourly for five days, and should be administered as soon as possible after diagnosis of COVID-19 has been made and within five days of symptom onset.

Trial Locations (4)

2193

Sunnyside Office Park, Johannesburg

2571

The Aurum Institute: Gavin J Churchyard Legacy Centre Klerksdorp Clinical Research Centre, Klerksdorp

3935

Nelson R. Mandela School of Medicine 3rd Floor, K-RITH Tower Building, Durban

5099

Nelson Mandela Academic Clinical Research Unit (NeMACRU), Umtata

All Listed Sponsors
collaborator

Bill and Melinda Gates Foundation

OTHER

lead

University of Witwatersrand, South Africa

OTHER