Study of MK-4482 for Prevention of Coronavirus Disease 2019 (COVID-19) in Adults (MK-4482-013)

• Status: Recruiting
• Trial end date: 2022-04-03
• Target enrollment: 0
• Participant gender: All

Summary

The primary objectives of this phase 3, multicenter, randomized, double-blind, placebo-controlled study are to determine the efficacy, and safety/tolerability, of molnupiravir (MK-4482) in adults who reside with a person infected with COVID-19. It is hypothesized that molnupiravir is superior to placebo in preventing laboratory-confirmed COVID-19 infection through Day 14 in participants (regardless of baseline viral test result) who do not have confirmed or suspected COVID-19 at time of screening and randomization.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.

Criteria

Inclusion Criteria:

• Lives in a household with an index case where the index case is a person with documented COVID-19 (laboratory-confirmed SARS-CoV-2 infection with symptoms case) and must have 1) a first positive SARS-CoV-2 test result from a sample collected within ≤5 days prior to randomization of the participant, and 2) at least 1 symptom attributable to COVID-19 (e.g., fever, difficulty breathing)

• Does not have confirmed or suspected COVID-19

• Is willing and able to take oral medication

• Is male and willing to be abstinent from heterosexual intercourse or use acceptable contraception during the study and for ≥4 days after the last dose of study intervention

• Is female and not pregnant/breastfeeding and at least one of the following applies during the study and for ≥4 days after: is not a woman of childbearing potential (WOCBP), is a WOCBP and uses highly effective contraception (low user dependency method OR a user dependent hormonal method in combination with a barrier method), or is a WOCBP who is abstinent from heterosexual intercourse

Exclusion Criteria:

• Has a prior history of laboratory-confirmed SARS-CoV-2 infection (with or without symptoms) or has a prior positive test results for anti-SARS-CoV-2 antibodies

• Is on dialysis or has renal impairment

• Has either of the following: 1) human immunodeficiency virus (HIV) with a recent viral load >50 copies/mL (regardless of CD4 count) or an acquired immunodeficiency syndrome (AIDS)-defining illness; or 2) neutrophilic granulocyte absolute count <500/mm^3

• Has a history of hepatitis B virus (HBV) or hepatitis C virus (HCV) infection with any of the following: cirrhosis, end-stage liver disease, hepatocellular carcinoma; aspartate transaminase (AST) and/or (ALT) >3x upper limit of normal at screening

• Has a low platelet count or received a platelet transfusion within 5 days prior to randomization

• Has hypersensitivity or other contraindication to any of the components of the study interventions as determined by the investigator

• 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

• Has received, is taking, or is anticipated to require any prohibited therapies

• Has received a COVID-19 vaccination with the first dose ≥7 days prior to randomization

• 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

• Has more than 1 individual currently (assessed at the time of consent), or within the last month, living in the household with confirmed or suspected COVID-19

• Is living in a household with >10 people