COVID-19 trials registries data warehouse

https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=21447

Zoe Nell

zoe.nell@merck.com

2022-02-04

Recruiting

RCT

Randomized

Parallel

Blind label

multi-center

Prevention

1.The participant is a household contact of an index case. An index case is a person with documented COVID-19 (laboratory-confirmed SARS-CoV-2 infection with symptoms case) and must have:a) A first detectable SARS-CoV-2 test result from a sample collected =5 days prior to randomization of the participant(s),AND b)At least 1 of the following symptoms attributable to COVID-19: fever =38.0ºC,chills,cough,sore throat, shortness of breath or difficulty breathing with exertion,fatigue,nasal congestion,runny nose,headache,muscle or body aches,nausea,vomiting,diarrhea,loss of taste,or loss of smell, with symptom onset no earlier than 5 days prior to randomization of the participant(s).2.The participant does not have confirmed or suspected COVID-19.3.The participant is willing and able to take oral medication.4.The participant is male or female =18 years of age,at the time of providing documented informed consent.5. There are no contraceptive requirements for male participants per protocol.However,where applicable,male participants are only eligible to participate if they agree to follow local labelling (or local ethics or regulatory authority requirement) regardingcontraception.6. A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies:•Is not a WOCBP OR •Is a WOCBP and:- Uses a contraceptive method that is highly effective (a low user dependency method OR a user dependent hormonal method in combination with barrier method), or be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis),during the intervention period and for at least 4 days after the last dose of study intervention.7.The participant’s index case (or legally acceptable representative of the index case) has provided documented informed consent/assent for the collection of COVID-19 documentation requirements.8. Documented informed consent.

1. The participant has a prior history of laboratory-confirmed SARS-CoV-2 infection (with or without symptoms), within 6 months prior to randomization.2.The participant has either of the following conditions:-HIV with a recent viral load >50 copies/mL (regardless of CD4 count) or an AIDS defining illness in the past 6 months.Note: Participants with HIV may only be enrolled if on a stable antiretroviral therapy regimen.3.The participant has a history of HBV or HCV infection with any of the following:Cirrhosis,End-stage liver disease,Hepatocellular carcinoma, AST and/or ALT >3X upper limit of normal at screening.4.The participant has hypersensitivity or other contraindication to any of the components of the study interventions as determined by the investigator. 5.The participant has any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant or that could prevent, limit, or confound the protocol-specified assessments including but not limited to participants with conditions that could limit gastrointestinal absorption of capsule contents.6.The participant has received, is taking, or is anticipated to require any prohibited therapies. 7. The participant has received a COVID-19 vaccine with the first dose 7 days or more prior to randomization.8.The participant is unwilling to abstain from participating in another interventional clinical study through Day 29 with an investigational compound or device, including those for COVID-19 therapeutics.9.The participant is living in a household of more than 10 people. 10. Is or has an immediate family member (eg, spouse, parent/legal guardian, sibling, or child) who is investigational site or Sponsor staff directly involved with this study.

2

MSD Pty Ltd

18

90

Kenya;South Africa

Close contacts to covid patients

N/A

150

The primary efficacy endpoint is the proportion of participants developing COVID-19 (laboratory­ confirmed SARS-CoV-2 infection with symptoms) through Day 14

| Declared number of arm (2.0) differs from found arms (3.0)

Phase 3

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