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

Completed · Phase 3 · Has a placebo group

Conditions studied: Coronavirus Disease (COVID-19)

In brief

The purpose of the study is to assess if the study medication (molnupiravir, MK-4482) will prevent symptomatic coronavirus disease 2019 (COVID-19) in adults who live with someone with confirmed COVID-19 infection. This is a phase 3, multicenter, randomized, double-blind, placebo-controlled study; half of the study participants will receive molnupiravir twice daily by mouth and the other half will receive a placebo. The primary objectives of the study are to determine if molnupiravir prevents symptomatic COVID-19 disease and to evaluate its safety and tolerability. All participants who develop COVID-19 during the study are still eligible for any COVID-19 treatment recommended by their doctor.

Key facts

Study ID

NCT04939428

Run by

Merck Sharp & Dohme LLC

People needed

2441

Starts

2021-08-11

Expected to finish

2022-11-16

Last updated by the study team

2024-09-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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 detectable 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
• For males, agrees to be abstinent from penile-vaginal intercourse OR agrees to use a highly effective contraceptive method while receiving study drug and for ≥3 months after the last dose of study drug
• 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

You may not qualify if…

• Has a prior history of laboratory-confirmed SARS-CoV-2 infection (with or without symptoms) within 6 months prior to randomization
• Has either of the following: human immunodeficiency virus (HIV) with a recent viral load >50 copies/mL (regardless of CD4 count) or an acquired immunodeficiency syndrome (AIDS)-defining illness
• 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 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
• Is living in a household with >10 people

Where it is running

• The Institute for Liver Health DBA Arizona Clinical Trials ( Site 2484) — Mesa, Arizona, United States
• The Institute for Liver Health DBA Arizona Clinical Trials ( Site 2448) — Tucson, Arizona, United States
• Hope Clinical Research ( Site 2400) — Canoga Park, California, United States
• Carbon Health ( Site 2515) — Carlsbad, California, United States
• UCSF Fresno ( Site 2528) — Fresno, California, United States
• ASCADA Research, LLC ( Site 2516) — Fullerton, California, United States
• Marvel Clinical Research ( Site 2490) — Huntington Beach, California, United States
• National Research Institute ( Site 2452) — Los Angeles, California, United States
• Valley Clinical Trials Inc. ( Site 2406) — Northridge, California, United States
• Carbon Health ( Site 2514) — Oakland, California, United States
• University of California Davis ( Site 2497) — Sacramento, California, United States
• Millennium Clinical Trials ( Site 2468) — Simi Valley, California, United States
• Future Innovative Treatments, LLC ( Site 2471) — Colorado Springs, Colorado, United States
• Emerson Clinical Research Institute ( Site 2457) — Washington D.C., District of Columbia, United States
• Synergy Healthcare ( Site 2521) — Bradenton, Florida, United States
• Accel Research Sites-DeLand Clinical Research Unit ( Site 2535) — DeLand, Florida, United States
• Velocity Clinical Research, Hallandale Beach ( Site 2485) — Hallandale, Florida, United States
• Indago Research and Health Center Inc ( Site 2412) — Hialeah, Florida, United States
• Advanced Research For Health Improvement LLC ( Site 2436) — Immokalee, Florida, United States
• Clinical Site Partners, LLC d/b/a CSP Miami ( Site 2508) — Miami, Florida, United States
• CDC Research Institute, LLC ( Site 2540) — Port Saint Lucie, Florida, United States
• Clinical Research Trials of Florida ( Site 2402) — Tampa, Florida, United States
• Clinical Site Partners, LLC d/b/a CSP Miami ( Site 2425) — Winter Park, Florida, United States
• Balanced Life Healthcare Solutions/SKYCRNG ( Site 2539) — Lawrenceville, Georgia, United States
• Cahaba Research, Inc. ( Site 2523) — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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