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

  • STATUS
    Recruiting
  • End date
    Nov 30, 2021
  • participants needed
    1450
  • sponsor
    Merck Sharp & Dohme Corp.
Updated on 9 January 2021
Investigator
Toll Free Number
Primary Contact
Emerson Clinical Research Institute ( Site 1828) (4.4 mi away) Contact
+75 other location

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

Details
Treatment Placebo, Molnupiravir
Clinical Study IdentifierNCT04575597
SponsorMerck Sharp & Dohme Corp.
Last Modified on9 January 2021

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Eligibility

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Inclusion Criteria

Do you have any of these conditions: Do you have Coronavirus Disease??
Do you have any of these conditions: Do you have Coronavirus Disease??
Do you have any of these conditions: Do you have Coronavirus Disease??
Do you have any of these conditions: Do you have Coronavirus Disease??
Do you have any of these conditions: Do you have Coronavirus Disease??
Do you have any of these conditions: Do you have Coronavirus Disease??
Do you have any of these conditions: Do you have Coronavirus Disease??
Do you have any of these conditions: Do you have Coronavirus Disease??
Do you have any of these conditions: Do you have Coronavirus Disease??
Do you have any of these conditions: Do you have Coronavirus Disease??
Is your age greater than or equal to 18 yrs?
Do you have any of these conditions: Do you have Coronavirus Disease??
Do you have any of these conditions: Do you have Coronavirus Disease??
Do you have any of these conditions: Do you have Coronavirus Disease??
Do you have any of these conditions: Do you have Coronavirus Disease??
Do you have any of these conditions: Do you have Coronavirus Disease??
Do you have any of these conditions: Do you have Coronavirus Disease??
Do you have Coronavirus Disease?
Gender: Male or Female
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 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 7 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. 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
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 28 days from the start 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
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

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 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 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 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/L or received a platelet transfusion in the 5 days prior to randomization
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, or participants with conditions that could limit gastrointestinal absorption of capsule contents
Has hypersensitivity or other contraindication to any of the components of the study interventions as determined by the investigator
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