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History of Changes for Study: NCT04575597
Efficacy and Safety of Molnupiravir (MK-4482) in Non-Hospitalized Adult Participants With COVID-19 (MK-4482-002)
Latest version (submitted May 18, 2022) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 October 2, 2020 None (earliest Version on record)
2 October 27, 2020 Recruitment Status, Study Status and Contacts/Locations
3 November 6, 2020 Study Status and Contacts/Locations
4 November 10, 2020 Contacts/Locations and Study Status
5 November 19, 2020 Contacts/Locations and Study Status
6 November 25, 2020 Contacts/Locations and Study Status
7 December 1, 2020 Study Status and Contacts/Locations
8 December 9, 2020 Study Status and Contacts/Locations
9 December 14, 2020 Study Status and Study Identification
10 December 18, 2020 Contacts/Locations and Study Status
11 December 22, 2020 Outcome Measures, Contacts/Locations, Eligibility, Arms and Interventions and Study Status
12 December 30, 2020 Contacts/Locations and Study Status
13 January 15, 2021 Contacts/Locations and Study Status
14 January 20, 2021 Study Status
15 January 22, 2021 Contacts/Locations and Study Status
16 January 28, 2021 Contacts/Locations and Study Status
17 February 9, 2021 Study Status and Contacts/Locations
18 February 17, 2021 Contacts/Locations and Study Status
19 February 24, 2021 Contacts/Locations and Study Status
20 March 11, 2021 Contacts/Locations and Study Status
21 March 15, 2021 Contacts/Locations and Study Status
22 March 16, 2021 Contacts/Locations and Study Status
23 March 25, 2021 Contacts/Locations and Study Status
24 April 1, 2021 Contacts/Locations and Study Status
25 April 9, 2021 Contacts/Locations and Study Status
26 April 16, 2021 Contacts/Locations and Study Status
27 May 25, 2021 Study Status, Contacts/Locations, Arms and Interventions, Eligibility and Study Design
28 May 28, 2021 Contacts/Locations and Study Status
29 June 2, 2021 Study Status and Contacts/Locations
30 June 10, 2021 Contacts/Locations and Study Status
31 June 17, 2021 Contacts/Locations, Study Status and Study Identification
32 June 23, 2021 Contacts/Locations and Study Status
33 June 30, 2021 Contacts/Locations and Study Status
34 July 7, 2021 Contacts/Locations and Study Status
35 July 14, 2021 Contacts/Locations and Study Status
36 July 21, 2021 Contacts/Locations and Study Status
37 July 28, 2021 Contacts/Locations and Study Status
38 August 4, 2021 Contacts/Locations and Study Status
39 August 11, 2021 Contacts/Locations and Study Status
40 August 17, 2021 Study Status
41 August 25, 2021 Contacts/Locations and Study Status
42 September 2, 2021 Contacts/Locations and Study Status
43 September 10, 2021 Contacts/Locations and Study Status
44 September 15, 2021 Contacts/Locations and Study Status
45 September 22, 2021 Contacts/Locations and Study Status
46 September 30, 2021 Contacts/Locations and Study Status
47 October 8, 2021 Recruitment Status, Study Status and Contacts/Locations
48 November 2, 2021 Study Status
49 May 18, 2022 Recruitment Status, Study Status and Study Design
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Study NCT04575597
Submitted Date:  October 2, 2020 (v1)

Open or close this module Study Identification
Unique Protocol ID: 4482-002
Brief Title: Efficacy and Safety of Molnupiravir (MK-4482) in Non-Hospitalized Adult Participants With COVID-19 (MK-4482-002)
Official Title: A Phase 2/3, Randomized, Placebo-Controlled, Double-Blind Clinical Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of MK-4482 in Non-Hospitalized Adults With COVID-19.
Secondary IDs: 2020-003368-24 [EudraCT Number]
MK-4482-002 [Merck]
Open or close this module Study Status
Record Verification: October 2020
Overall Status: Not yet recruiting
Study Start: October 19, 2020
Primary Completion: April 11, 2021 [Anticipated]
Study Completion: October 14, 2021 [Anticipated]
First Submitted: September 30, 2020
First Submitted that
Met QC Criteria:
October 2, 2020
First Posted: October 5, 2020 [Actual]
Last Update Submitted that
Met QC Criteria:
October 2, 2020
Last Update Posted: October 5, 2020 [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: This study aims to evaluate the safety, tolerability and efficacy of molnupiravir (MK-4482) compared to placebo. The primary hypothesis is that molnupiravir is superior to placebo as assessed by the percentage of participants who are hospitalized and/or die through Day 29
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: Treatment
Study Phase: Phase 2/Phase 3
Interventional Study Model: Parallel Assignment
Number of Arms: 6
Masking: Double (Participant, Investigator)
Allocation: Randomized
Enrollment: 1450 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: Part 1: Molnupiravir 200 mg
200 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)
Drug: Molnupiravir
Molnupiravir administered orally in capsule form every 12 hours for 5 days (10 doses total)
Experimental: Part 1: Molnupiravir 400 mg
400 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)
Drug: Molnupiravir
Molnupiravir administered orally in capsule form every 12 hours for 5 days (10 doses total)
Experimental: Part 1: Molnupiravir 800 mg
800 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)
Drug: Molnupiravir
Molnupiravir administered orally in capsule form every 12 hours for 5 days (10 doses total)
Placebo Comparator: Part 1: Placebo
Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total)
Drug: Placebo
Placebo matching molnupiravir administered orally in capsule form every 12 hours for 5 days (10 doses total)
Experimental: Part 2: Molnupiravir
Molnupiravir (dose to be selected) administered orally every 12 hours for 5 days (10 doses total)
Drug: Molnupiravir
Molnupiravir administered orally in capsule form every 12 hours for 5 days (10 doses total)
Placebo Comparator: Part 2: Placebo
Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total)
Drug: Placebo
Placebo matching molnupiravir administered orally in capsule form every 12 hours for 5 days (10 doses total)
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Percentage of participants who are hospitalized and/or die
[ Time Frame: Up to 29 days ]

Hospitalization (all cause) is ≥24 hours of acute care in a hospital or similar acute care facility. Death is due to any cause.
2. Percentage of participants with an adverse event (AE)
[ Time Frame: Up to 19 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 who discontinued study intervention due to an AE
[ Time Frame: Up to 6 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. Time to improvement or resolution of targeted COVID-19 signs/symptoms
[ Time Frame: Up to 29 days ]

The number of days from randomization to the first day on or before study Day 29 by which the targeted self-reported signs/symptoms improve or resolve.
2. Time to progression of targeted COVID-19 signs/symptoms
[ Time Frame: Up to 29 days ]

The number of days from randomization to the first day on or before study Day 29 by which the targeted self-reported signs/symptoms are newly reported or worsen.
3. WHO 11-point outcomes score on a scale
[ Time Frame: Up to 29 days ]

The World Health Organization (WHO) outcome scale is an 11-point ordinal score that categorizes clinical progression. Score ranges from 0 to 10 with higher score indicating clinical progression.
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion Criteria:

  • Has documentation of polymerase chain reaction (PCR)-confirmed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection with sample collection ≤7 days prior to randomization. PCR is the preferred method; however other diagnostic methods are allowed if authorized by use in the country.
  • Has initial onset of signs/symptoms attributable to COVID-19 for ≤7 days prior to randomization and at least 1 sign/symptom attributable to COVID-19 on the day of randomization
  • Has mild or moderate COVID-19. Participants with mild COVID-19 must have at least 1 characteristic or underlying medical condition associated with an increased risk of severe illness from COVID-19
  • Has oxygenation saturation of >93% (on room air OR on supplemental oxygen prior to randomization which has not increased since onset of COVID-19 signs/symptoms) obtained at rest by study staff at randomization.
  • Is willing and able to take oral medication
  • Males agree to the following during the intervention period and for at least 90 days after the last dose of study intervention: Refrain from donating sperm; and either abstain from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent; or must agree to use contraception
  • Females are not pregnant or breastfeeding, and at least one of the following conditions applies: Is not a woman of child bearing potential (WOCBP); or is a WOCBP and using a contraceptive method that is highly effective (a low user dependency method OR a user dependent method in combination with barrier method), or be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis) during the intervention period and for at least 7 months after the last dose of study intervention; a WOCBP must have a negative highly sensitive pregnancy test (urine or serum test is required) within 24 hours before the first dose of study intervention.

Exclusion Criteria:

  • Is currently hospitalized or is expected to need hospitalization for COVID-19 within 48 hours of randomization
  • Is on dialysis or has reduced estimated glomerular filtration rate (eGFR) <30 mL/min/1.73m^2 by the Modification of Diet in Renal Disease (MDRD) equation
  • Has any of the following conditions: human immunodeficiency virus (HIV) with a recent viral load >50 copies/mL or cluster of differentiation 4 (CD4) <200 cell/mm^3; chemotherapy required within 6 weeks before randomization; a neutrophilic granulocyte absolute count <500/mm^3; autologous or allogeneic hematopoietic stem cell transplant recipient
  • Has an active diagnosis of hepatitis due to any cause
  • Has a history of acute pancreatitis within 3 months prior to randomization or a history of chronic pancreatitis
  • Is taking or is anticipated to require any prohibited therapies
  • 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 a baseline heart rate of < 50 beats per minute at rest
  • Has a platelet count <100,000/μL or received a platelet transfusion in the 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 who are not expected to survive longer than 48 hours after randomization, participants who are expected to require mechanical ventilation within 48 hours after randomization, or participants with a recent history of mechanical ventilation not associated with COVID-19, or participants with conditions that could limit gastrointestinal absorption of capsule contents.
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
Links:
Available IPD/Information:

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U.S. National Library of Medicine | U.S. National Institutes of Health | U.S. Department of Health & Human Services