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Efficacy and Safety of Molnupiravir (MK-4482) in Non-Hospitalized Adult Participants With COVID-19 (MK-4482-002)

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ClinicalTrials.gov Identifier: NCT04575597
Recruitment Status : Recruiting
First Posted : October 5, 2020
Last Update Posted : September 16, 2021
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

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

Condition or disease Intervention/treatment Phase
Coronavirus Disease (COVID-19) Drug: Molnupiravir Drug: Placebo Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1850 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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.
Actual Study Start Date : October 19, 2020
Estimated Primary Completion Date : November 8, 2021
Estimated Study Completion Date : May 13, 2022

Arm Intervention/treatment
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)
Other Name: MK-4482

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)
Other Name: MK-4482

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)
Other Name: MK-4482

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 800 mg
800 mg 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)
Other Name: MK-4482

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)




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 ~7 months ]
    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 sustained resolution or improvement of each targeted COVID-19 sign/symptom [ Time Frame: Up to 29 days ]
    The number of days from randomization to the first day on or before study Day 29 for sustained resolution or improvement of each sign/symptom will be assessed.

  2. Time to progression of each targeted COVID-19 sign/symptom [ Time Frame: Up to 29 days ]
    The number of days from randomization to the first day on or before study Day 29 for each targeted self-reported sign/symptom will be assessed.

  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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Has documentation of laboratory confirmed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection with sample collection ≤5 days prior to the day of randomization. PCR is the preferred method; however with evolving approaches to laboratory confirmation of SARS-CoV-2 infection, other molecular or antigen tests that detect viral ribonucleic acid (RNA) or protein are allowed if authorized for use in the country. Serological tests that detect host antibodies generated in response to recent or prior infection are not allowed.
  • Had initial onset of signs/symptoms attributable to COVID-19 for ≤5 days prior to the day of randomization and at least 1 of the following sign/symptom attributable to COVID-19 on the day of randomization.
  • Has mild or moderate COVID-19.
  • Has at least 1 characteristic or underlying medical condition associated with an increased risk of severe illness from COVID-19.
  • Males agree to the following during the intervention period and for at least 4 days after the last dose of study intervention: 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) for at least 4 days 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 (regardless of CD4 count) or an AIDS-defining illness in the past 6 months, participants with HIV may only be enrolled if on a stable antiretroviral therapy regimen; a neutrophilic granulocyte absolute count <500/mm^3.
  • Has a history of hepatitis B virus (HBV) or hepatitis C virus (HCV) with cirrhosis, end-stage liver disease, hepatocellular carcinoma, aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) >3X upper limit of normal at screening.
  • Has a platelet count <100,000/μL or received a platelet transfusion in the 5 days prior to randomization.
  • 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 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, or participants with a recent history of mechanical ventilation, or participants with conditions that could limit gastrointestinal absorption of capsule contents.

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): NCT04575597


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.
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Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT04575597    
Other Study ID Numbers: 4482-002
2020-003368-24 ( EudraCT Number )
MK-4482-002 ( Other Identifier: Merck )
PHRR201209-003186 ( Registry Identifier: PHRR )
jRCT2031210148 ( Registry Identifier: jRCT )
First Posted: October 5, 2020    Key Record Dates
Last Update Posted: September 16, 2021
Last Verified: September 2021
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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Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases