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

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ClinicalTrials.gov Identifier: NCT04939428
Recruitment Status : Recruiting
First Posted : June 25, 2021
Last Update Posted : January 12, 2022
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Coronavirus Disease (COVID-19) Drug: Molnupiravir Drug: Placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1332 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official 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
Actual Study Start Date : August 11, 2021
Estimated Primary Completion Date : April 3, 2022
Estimated Study Completion Date : April 3, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Molnupiravir
Participants take molnupiravir 800 mg every 12 hours (Q12H) on Days 1 to 5.
 Drug: Molnupiravir
Four molnupiravir 200 mg capsules taken by mouth.
Other Name: MK-4482
Placebo Comparator: Placebo
Participants take placebo Q12H on Days 1 to 5.
 Drug: Placebo
Placebo capsule matched to molnupiravir 200 mg capsules taken by mouth.


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of participants with COVID-19 (laboratory-confirmed severe acute respiratory syndrome coronavirus 2 [SARS-CoV-2] infection with symptoms) through Day 14 [ Time Frame: Up to Day 14 ]
    Participants who experience targeted symptoms of COVID-19 (e.g., cough, sore throat) will have nasopharyngeal (NP) swabs tested for SARS-CoV-2 using reverse-transcription polymerase chain reaction (RT-PCR).

  2. Percentage of participants with ≥1 adverse event [ Time Frame: Up to 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 Outcome Measures :
  1. Percentage of participants who have undetectable SARS-CoV-2 in baseline nasopharyngeal (NP) swabs and develop COVID-19 (laboratory-confirmed SARS-CoV-2 infection with symptoms) on or before Day 14 [ Time Frame: Up to Day 14 ]
    Participants who experience targeted symptoms of COVID-19 (e.g., cough, sore throat) will have nasopharyngeal (NP) swabs tested for SARS-CoV-2 using reverse-transcription polymerase chain reaction (RT-PCR).

  2. Percentage of participants with COVID-19 (laboratory-confirmed SARS-CoV-2 infection with symptoms) through Day 29 [ Time Frame: Up to Day 29 ]
    Participants who experience targeted symptoms of COVID-19 (e.g., cough, sore throat) will have nasopharyngeal (NP) swabs tested for SARS-CoV-2 using reverse-transcription polymerase chain reaction (RT-PCR).

  3. Percentage of participants who have undetectable SARS-CoV-2 in baseline NP swabs and develop detectable SARS-CoV-2 in NP swabs on or before Day 14 [ Time Frame: Time of screening and Days 5 and 14 ]
    All participants will have nasopharyngeal (NP) swabs collected at screening and Days 5 and 14 to test for SARS-CoV-2 using reverse-transcription polymerase chain reaction (RT-PCR).


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04939428


Contacts
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Contact: Toll Free Number 1-888-577-8839 Trialsites@merck.com

Locations
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Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
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Study Director: Medical Director Merck Sharp & Dohme Corp.
More Information
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Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT04939428    
Other Study ID Numbers: 4482-013
MK-4482-013 ( Other Identifier: Merck )
jRCT2031210281 ( Registry Identifier: jRCT (Japan Registry of Clinical Trials) )
PHRR211007-003980 ( Registry Identifier: PHRR )
2021-000904-39 ( EudraCT Number )
First Posted: June 25, 2021    Key Record Dates
Last Update Posted: January 12, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
URL: http://engagezone.msd.com/ds_documentation.php

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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COVID-19
Coronavirus Infections
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
 Virus Diseases
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases