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Completed

NCT Number: NCT04939428

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hospital Italiano de Buenos Aires ( Site 0102), CABA, Buenos Aires, Argentina

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Molnupiravir

Drug

Four molnupiravir 200 mg capsules taken by mouth.

Other names: MK-4482

Placebo

Drug

Placebo capsule matched to molnupiravir 200 mg capsules taken by mouth.

Primary outcomes

  1. Percentage of Participants Who Had Undetectable SARS-CoV-2 in Baseline Nasopharyngeal (NP) Swabs and Developed COVID-19 (Laboratory-Confirmed SARS-CoV-2 Infection With Symptoms) Through Day 14

    Time frame: Day 14

    Percentage of participants who had undetectable SARS-CoV-2 in baseline NP swabs and developed COVID-19 (laboratory-confirmed SARS-CoV-2 infection with symptoms) through Day 14 were reported.

  2. Percentage of Participants With ≥1 Adverse Event

    Time frame: 29 days

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.

  3. Percentage of Participants Discontinuing From Study Therapy Due to AE

    Time frame: Up to 5 days

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.

Secondary outcomes

  1. Percentage of Participants (Regardless of SARS-CoV-2 in Baseline NP Swabs) Who Developed COVID-19 (Laboratory-Confirmed SARS-CoV-2 Infection With Symptoms) Through Day 14

    Time frame: Up to Day 14

    Participants who experienced targeted symptoms of COVID-19 (e.g., cough, sore throat) and had NP swabs tested for SARS-CoV-2 using reverse-transcription polymerase chain reaction (RT-PCR).Efficacy analysis was conducted on the mITT (modified intent to treat) population consisting of all randomized participants who received at least 1 dose of study intervention.

  2. Percentage of Participants Who Had Undetectable SARS-CoV-2 in Baseline NP Swabs and Developed COVID-19 (Laboratory-Confirmed SARS-CoV-2 Infection With Symptoms) Through Day 29

    Time frame: Up to Day 29

    Participants who experienced targeted symptoms of COVID-19 (e.g., cough, sore throat) and had NP swabs tested for SARS-CoV-2 using RT-PCR. The efficacy analysis population was the mITT (modified intent to treat) population consisting of all randomized participants who received at least 1 dose of study intervention.

  3. Percentage of Participants Who Had Undetectable SARS-CoV-2 in Baseline NP Swabs and Developed Detectable SARS-CoV-2 in NP Swabs on or Before Day 14

    Time frame: Up to Day 14

    All participants had NP swabs collected at screening and through Day 14 to test for SARS-CoV-2 using RT-PCR. Efficacy analysis was conducted on the mITT (modified intent to treat) population consisting of all randomized participants who received at least 1 dose of study intervention.

  4. Percentage of Participants Who Had Detectable SARS-CoV-2 in Baseline NP Swabs and Developed COVID-19 (Laboratory-confirmed SARS-CoV-2 Infection With Symptoms) Through Day 14

    Time frame: Up to Day 14

    Participants who experienced targeted symptoms of COVID-19 (e.g., cough, sore throat) and had NP swabs tested for SARS-CoV-2 using RT-PCR. Efficacy analysis was conducted on the mITT (modified intent to treat) population consisting of all randomized participants who received at least 1 dose of study intervention.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of MK-4482 for the Prevention of COVID-19 (Laboratory-confirmed SARS-CoV-2 Infection With Symptoms) in Adults Residing With a Person With COVID-19

Acronym: MOVe-AHEAD

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jun 25, 2021
Registry last updated
Sep 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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