A Randomised, Multi-centre, Double-blind, Phase 3 Study to Observe the Effectiveness, Safety and … (NCT05459532) | Clinical Trial Compass
CompletedPhase 2/3
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
South Africa59 participantsStarted 2022-08-12
Plain-language 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.
Who can participate
Age range50 Years
SexALL
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Inclusion criteria
✓. 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.
Exclusion criteria
✕
What they're measuring
1
To evaluate the effectiveness of molnupiravir compared to placebo in preventing severe disease progression in adults with mild COVID-19
Timeframe: 29 Days
2
To evaluate the safety of molnupiravir in adults with mild COVID-19
Timeframe: 29 Days
3
To evaluate the safety of molnupiravir in adults with mild COVID-19
. Pregnant or breastfeeding women, or women planning/desiring to become pregnant during the 28 days following enrolment into the study.
✕. Duration of self-reported symptoms of COVID-19 for more than five days prior to screening.
✕. Signs of respiratory distress or severe disease prior to enrolment, including:
✕. Inability/unlikely to be in the study area for the duration of the 28-day follow-up period.
✕. Inability to tolerate oral medications.
✕. Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of drugs, or which may jeopardize the safety of the patient or the objectives of the study. The Investigator should make this determination in consideration of the volunteer's medical history.
✕. The volunteer is assessed to be clinically unstable in the Investigator's opinion.
✕. Participation in another investigational study involving an investigational product within 30 days, or 5 half-lives, whichever is longer, prior to screening.