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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04939428
Recruitment Status : Recruiting
First Posted : June 25, 2021
Last Update Posted : October 3, 2022
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme LLC

Tracking Information
First Submitted Date  ICMJE June 24, 2021
First Posted Date  ICMJE June 25, 2021
Last Update Posted Date October 3, 2022
Actual Study Start Date  ICMJE August 11, 2021
Estimated Primary Completion Date December 11, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 29, 2022)
  • 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) through Day 14 [ Time Frame: Up to Day 14 ]
    Percentage of participants who have undetectable SARS-CoV-2 in baseline NP swabs and develop COVID-19 (laboratory-confirmed SARS-CoV-2) infection with symptoms) through Day 14.
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: June 24, 2021)
  • 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).
  • 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.
  • 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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 29, 2022)
  • Percentage of participants (regardless of SARS-CoV-2 in baseline NP swabs) who develop COVID-19 (laboratory-confirmed 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 NP swabs tested for SARS-CoV-2 using reverse-transcription polymerase chain reaction (RT-PCR).
  • Percentage of participants who have undetectable SARS-CoV-2 in baseline NP swabs and develop 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 NP swabs tested for SARS-CoV-2 using RT-PCR.
  • 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: Up to Day 14 ]
    All participants will have NP swabs collected at screening and through Day 14 to test for SARS-CoV-2 using RT-PCR.
  • Percentage of participants who have detectable SARS-CoV-2 in baseline NP swabs and develop COVID-19 (laboratory-confirmed 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 NP swabs tested for SARS-CoV-2 using RT-PCR.
Original Secondary Outcome Measures  ICMJE
 (submitted: June 24, 2021)
  • 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).
  • 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).
  • 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).
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of MK-4482 for Prevention of Coronavirus Disease 2019 (COVID-19) in Adults (MK-4482-013)
Official Title  ICMJE 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
Brief 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Coronavirus Disease (COVID-19)
Intervention  ICMJE
  • Drug: Molnupiravir
    Four molnupiravir 200 mg capsules taken by mouth.
    Other Name: MK-4482
  • Drug: Placebo
    Placebo capsule matched to molnupiravir 200 mg capsules taken by mouth.
Study Arms  ICMJE
  • Experimental: Molnupiravir
    Participants take molnupiravir 800 mg every 12 hours (Q12H) on Days 1 to 5.
    Intervention: Drug: Molnupiravir
  • Placebo Comparator: Placebo
    Participants take placebo Q12H on Days 1 to 5.
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 13, 2022)
1376
Original Estimated Enrollment  ICMJE
 (submitted: June 24, 2021)
1332
Estimated Study Completion Date  ICMJE December 11, 2022
Estimated Primary Completion Date December 11, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Toll Free Number 1-888-577-8839 Trialsites@merck.com
Listed Location Countries  ICMJE Argentina,   Brazil,   Bulgaria,   Colombia,   Dominican Republic,   Egypt,   France,   Guatemala,   Hungary,   Japan,   Kenya,   Malaysia,   Mexico,   Peru,   Philippines,   Romania,   Russian Federation,   South Africa,   Spain,   Thailand,   Turkey,   Ukraine,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04939428
Other Study ID Numbers  ICMJE 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 )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
URL: http://engagezone.msd.com/ds_documentation.php
Current Responsible Party Merck Sharp & Dohme LLC
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Merck Sharp & Dohme LLC
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Director Merck Sharp & Dohme LLC
PRS Account Merck Sharp & Dohme LLC
Verification Date September 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP