COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT05459532

Bukani X Dyariwe

bdyariwe@ezintsha.org

2022-07-15

Recruiting

RCT

Randomized

Parallel

Blind label

multi-center

Treatment

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. 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. -

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. personnel (e.g., investigator, sub-investigator, research assistant, pharmacist, study coordinator or anyone mentioned in the delegation log) directly involved in the conduct of the study. any physical, mental, or social condition, drug/alcohol use, history of illness or laboratory abnormality that, in the investigator's judgment, might jeopardise the safety of the patient in the context of this study, or might interfere with study procedures or the ability of the subject to adhere to and complete the study. the investigator should make this determination in consideration of the volunteer's medical history.

2

University of Witwatersrand, South Africa

50

100

South Africa

Mild/moderate disease at enrollment

2: Mild/moderate disease at enrollment

4000

To evaluate the effectiveness of molnupiravir compared to placebo in preventing severe disease progression in adults with mild COVID-19;To evaluate the safety of molnupiravir in adults with mild COVID-19;To evaluate the safety of molnupiravir in adults with mild COVID-19

None

Phase 3

[{"arm_notes": "200mg", "treatment_id": 813, "treatment_name": "Molnupiravir", "treatment_type": "Antivirals", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "nan", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]