This is a Multi-centre, Double-blind, Phase 3 Study to Observe the Effectiveness, Safety, and Tolerability of Molnupiravir 800 mg Administered 12-hourly for Five Days to Adult Patients With Mild COVID-19 at the Time of Enrolment Who Are at Risk of Progression to Severe Disease, Compared to a Placebo. Patients With Recent Onset of COVID-19 Symptoms Will be Screened to Assess Eligibility for Enrolment. Confirmation of SARS-CoV-2 Infection Will be Performed Through Rapid Antigen Detection Using the LumiraDx Point of Care Diagnostic Platform.

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

This is a multi-centre, double-blind, phase 3 study to observe the effectiveness, safety, and tolerability of molnupiravir 800 mg administered 12-hourly for five days in adult patients with mild COVID-19 at the time of enrolment, who are at risk of progression to severe disease, compared to a placebo.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 50
Healthy Volunteers: Accepts Healthy Volunteers
View:

• Able and willing to provide written or electronic informed consent prior to any study-specific procedure.

• Age ≥50 at the time of signing the informed consent form.

• Women of reproductive potential must have a negative pregnancy test at screening and be using a highly effective method of contraception. Highly effective methods of contraception

• A male participant must wear a condom when engaging in any activity that allows for passage of ejaculate to another while taking the investigational product. Male participants should also be advised of the benefit for a female partner to use a highly effective method of contraception as condom may break or leak.

• Self-reported symptoms of COVID-19 with onset no more than five days prior to screening informed consent including at least one of, fever or chills, cough, sore throat, rhinorrhoea or rhinitis or sinusitis, shortness of breath, headache, myalgia, new onset anosmia or ageusia, nausea, diarrhoea, or extreme fatigue, or other symptoms recognized in local and international guidelines as typical of mild COVID-19.

• SARS-CoV-2 infection confirmed through a positive LumiraDx rapid antigen test on the day of screening or a positive RT-PCR within two days prior to screening.

• Participant is at high risk for progression to severe COVID-19, this defined as either:

• Age ≥50 with at least one of the following background or medical conditions: diabetes mellitus, obesity (BMI 30 kg/m2), hypertension, HIV, active or previous TB.

• Age ≥65

• Participant agrees to comply with study procedures, including the completion of a daily diary for 10 days from the time of enrolment, and to be available for study contacts and visits.

Locations
Other Locations
South Africa
Nelson R. Mandela School of Medicine 3rd Floor, K-RITH Tower Building
Recruiting
Durban
Sunnyside Office Park
Recruiting
Johannesburg
The Aurum Institute: Gavin J Churchyard Legacy Centre Klerksdorp Clinical Research Centre
Recruiting
Klerksdorp
Nelson Mandela Academic Clinical Research Unit (NeMACRU)
Recruiting
Umtata
Contact Information
Primary
Bukani X Dyariwe
bdyariwe@ezintsha.org
0110844961
Backup
Simiso M Sokhela
ssokhela@ezintsha.org
0110844933
Time Frame
Start Date: August 12, 2022
Estimated Completion Date: July 2027
Participants
Target number of participants: 4000
Treatments
Experimental: Monulpiravir
Eligible participants will be randomised in a 1:1 manner to receive either molnupiravir 800 mg orally approximately 12-hourly for five days or a placebo for the equivalent amount of time.
Placebo Comparator: Placebo
Eligible participants will be randomised in a 1:1 manner to receive either molnupiravir 800 mg orally approximately 12-hourly for five days or a placebo for the equivalent amount of time.
Authors
Mark Siedner, James C Innes, Tanya Nielson, Ngcebo Mhlongo, Joana Woods, Ngundu Behuhuma, Bulelwa Mabindla, Karlien Moller, Ncomeka Manentsa, Francois WD Venter, Oteng Letlape, Sinalo Toni, Mgcini Moyo, Raesibe AP Selepe, Esther S Bhasker, Thozama Dubula, Simiso M Sokhela, Bronwyn Bosch, Nomathemba Chandiwana
Sponsors
Leads: University of Witwatersrand, South Africa
Collaborators: Bill and Melinda Gates Foundation

This content was sourced from clinicaltrials.gov

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