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History of Changes for Study: NCT04939428
Study of MK-4482 for Prevention of Coronavirus Disease 2019 (COVID-19) in Adults (MK-4482-013) (MOVe-AHEAD)
Latest version (submitted December 5, 2022) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 June 24, 2021 None (earliest Version on record)
2 July 12, 2021 Study Status and Oversight
3 August 3, 2021 Study Status
4 August 20, 2021 Recruitment Status, Study Status and Contacts/Locations
5 August 25, 2021 Contacts/Locations and Study Status
6 September 2, 2021 Contacts/Locations and Study Status
7 September 17, 2021 Contacts/Locations, Eligibility, Study Description, Study Status and Study Identification
8 September 22, 2021 Contacts/Locations and Study Status
9 September 30, 2021 Contacts/Locations and Study Status
10 October 6, 2021 Contacts/Locations and Study Status
11 October 7, 2021 Study Status and Study Identification
12 October 12, 2021 Contacts/Locations and Study Status
13 October 20, 2021 Contacts/Locations and Study Status
14 October 27, 2021 Contacts/Locations and Study Status
15 November 11, 2021 Study Status and Contacts/Locations
16 November 18, 2021 Contacts/Locations and Study Status
17 November 25, 2021 Contacts/Locations and Study Status
18 December 1, 2021 Contacts/Locations and Study Status
19 December 8, 2021 Contacts/Locations and Study Status
20 December 15, 2021 Contacts/Locations and Study Status
21 December 22, 2021 Contacts/Locations and Study Status
22 December 30, 2021 Contacts/Locations and Study Status
23 January 6, 2022 Study Status and Contacts/Locations
24 January 11, 2022 Contacts/Locations and Study Status
25 February 4, 2022 Outcome Measures, Study Status, Contacts/Locations, Eligibility, Study Design and Study Description
26 February 18, 2022 Contacts/Locations and Study Status
27 February 23, 2022 Contacts/Locations and Study Status
28 March 4, 2022 Study Status and Contacts/Locations
29 March 9, 2022 Contacts/Locations and Study Status
30 March 17, 2022 Contacts/Locations and Study Status
31 March 25, 2022 Contacts/Locations and Study Status
32 March 30, 2022 Contacts/Locations and Study Status
33 April 7, 2022 Contacts/Locations and Study Status
34 April 29, 2022 Outcome Measures, Contacts/Locations, Eligibility, Study Description and Study Status
35 May 5, 2022 Contacts/Locations and Study Status
36 May 12, 2022 Contacts/Locations and Study Status
37 May 17, 2022 Contacts/Locations and Study Status
38 June 13, 2022 Contacts/Locations, Study Status and Study Design
39 June 22, 2022 Contacts/Locations and Study Status
40 June 29, 2022 Contacts/Locations and Study Status
41 July 7, 2022 Contacts/Locations and Study Status
42 July 15, 2022 Contacts/Locations and Study Status
43 July 21, 2022 Contacts/Locations and Study Status
44 July 29, 2022 Contacts/Locations and Study Status
45 August 8, 2022 Contacts/Locations and Study Status
46 August 11, 2022 Contacts/Locations and Study Status
47 August 25, 2022 Contacts/Locations and Study Status
48 September 2, 2022 Contacts/Locations and Study Status
49 September 9, 2022 Contacts/Locations and Study Status
50 September 15, 2022 Contacts/Locations and Study Status
51 September 21, 2022 Contacts/Locations and Study Status
52 September 29, 2022 Contacts/Locations and Study Status
53 October 10, 2022 Contacts/Locations and Study Status
54 October 13, 2022 Contacts/Locations and Study Status
55 October 20, 2022 Contacts/Locations and Study Status
56 October 28, 2022 Recruitment Status, Study Status and Contacts/Locations
57 December 5, 2022 Recruitment Status, Study Status and Study Design
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Study NCT04939428
Submitted Date:  June 24, 2021 (v1)

Open or close this module Study Identification
Unique Protocol ID: 4482-013
Brief Title: Study of MK-4482 for Prevention of Coronavirus Disease 2019 (COVID-19) in Adults (MK-4482-013) (MOVe-AHEAD)
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
Secondary IDs: 2021-000904-39 [EudraCT Number]
MK-4482-013 [Merck]
Open or close this module Study Status
Record Verification: June 2021
Overall Status: Not yet recruiting
Study Start: August 16, 2021
Primary Completion: February 25, 2022 [Anticipated]
Study Completion: February 25, 2022 [Anticipated]
First Submitted: June 24, 2021
First Submitted that
Met QC Criteria:
June 24, 2021
First Posted: June 25, 2021 [Actual]
Last Update Submitted that
Met QC Criteria:
June 24, 2021
Last Update Posted: June 25, 2021 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Merck Sharp & Dohme LLC
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: Yes
U.S. FDA-regulated Device: No
Data Monitoring: Yes
Open or close this module Study Description
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 who do not have confirmed or suspected COVID-19 at time of screening and randomization.
Detailed Description:
Open or close this module Conditions
Conditions: Coronavirus Disease (COVID-19)
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Prevention
Study Phase: Phase 3
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Allocation: Randomized
Enrollment: 1332 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
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 Names:
  • 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.
Open or close this module Outcome Measures
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 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).
2. 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).
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).
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
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 72 hours 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, 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)
  • 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
  • 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
Open or close this module Contacts/Locations
Study Officials: Medical Director
Study Director
Merck Sharp & Dohme LLC
Locations:
Open or close this module IPDSharing
Plan to Share IPD: Yes
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
Supporting Information:
Time Frame:
Access Criteria:
URL: http://engagezone.msd.com/ds_documentation.php
Open or close this module References
Citations:
Links:
Available IPD/Information:

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