Study of MK-4482 for Prevention of Coronavirus Disease 2019 (COVID-19) in Adults (MK-4482-013)
Condition: Coronavirus Disease (COVID-19)
MeSH terms: COVID-19; Coronavirus Infections
Intervention: Molnupiravir; Placebo
Intervention description: Four molnupiravir 200 mg capsules taken by mouth.; Placebo capsule matched to molnupiravir 200 mg capsules taken by mouth.
Intervention MeSH terms: Molnupiravir
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 2441.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      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.
    

Eligibility 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 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

        Exclusion Criteria:

          -  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