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

NCT05459532 - 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 | Biotech Hunter | Biotech Hunter