Efficacy and Safety of Molnupiravir (MK-4482) in Hospitalized Adult Participants With COVID-19 (MK-4482-001)

Stopped early · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Coronavirus Disease (COVID-19)

In brief

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 rate of sustained recovery through Day 29.

Key facts

Study ID

NCT04575584

Run by

Merck Sharp & Dohme LLC

People needed

304

Starts

2020-10-19

Expected to finish

2021-08-11

Last updated by the study team

2023-01-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Has documentation of polymerase chain reaction (PCR)-confirmed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection with sample collection ≤ 10 days prior to the day of randomization. PCR is the preferred method; however other diagnostic methods are allowed if authorized by use in the country
• Had initial onset of signs/symptoms attributable to COVID-19 for ≤10 days prior to the day of randomization and ≥1 sign/symptom attributable to COVID-19 present at randomization
• Requires medical care in the hospital for ongoing clinical manifestations of COVID-19 (not just for public health or quarantine purposes)
• Has mild, moderate, or severe COVID-19
• 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) for 28 days from the start of study intervention; a WOCBP must have a negative highly sensitive pregnancy test (serum test is required) within 24 hours before the first dose of study intervention

You may not qualify if…

• Has critical COVID-19 with any of the following: respiratory failure (including endotracheal intubation and mechanical ventilation, oxygen delivered by high-flow nasal cannula (flow rates >20L/min with fraction of delivered oxygen ≥ 0.5), noninvasive positive pressure ventilation, or extracorporeal membrane oxygenation (ECMO))
• 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 history of Hepatitis B or Hepatitis C infection with any of the following: 1) cirrhosis 2) end-stage liver disease 3) hepatocellular carcinoma 4) aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) > 3 times the upper limit of normal at screening
• 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 trial through Day 29 with an investigational compound or device, including those for COVID-19 therapeutics
• Is anticipated to require transfer to a non-study hospital within 72 hours
• 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 or 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

Where it is running

• Cedars-Sinai Medical Center ( Site 1822) — Los Angeles, California, United States
• University of California Davis Health ( Site 1809) — Sacramento, California, United States
• University Of Florida ( Site 1810) — Gainesville, Florida, United States
• Wellstar Kennestone Hospital ( Site 1801) — Marietta, Georgia, United States
• Loretto Hospital ( Site 1838) — Chicago, Illinois, United States
• LSU-HSC Shreveport ( Site 1824) — Shreveport, Louisiana, United States
• Henry Ford Health System ( Site 1821) — Detroit, Michigan, United States
• University of Mississippi Medical Center ( Site 1846) — Jackson, Mississippi, United States
• University of Nebraska Medical Center ( Site 1835) — Omaha, Nebraska, United States
• University of New Mexico, Health Sciences Center ( Site 1806) — Albuquerque, New Mexico, United States
• Carolinas Medical Center ( Site 1850) — Charlotte, North Carolina, United States
• ECU Adult Specialty Care ( Site 1865) — Greenville, North Carolina, United States
• Sanford Health ( Site 1851) — Fargo, North Dakota, United States
• Temple University ( Site 1836) — Philadelphia, Pennsylvania, United States
• CHRISTUS Institute for Innovation & Advanced Clinical Care ( Site 1864) — Corpus Christi, Texas, United States
• Houston Methodist Hospital ( Site 1863) — Houston, Texas, United States
• Swedish Medical Center ( Site 1812) — Edmonds, Washington, United States
• Valley Medical Center ( Site 1815) — Renton, Washington, United States
• Swedish Medical Center ( Site 1861) — Seattle, Washington, United States
• Chronos Pesquisa Clínica ( Site 0105) — Brasília, Federal District, Brazil
• Santa Casa de Misericordia de Belo Horizonte ( Site 0100) — Belo Horizonte, Minas Gerais, Brazil
• Hospital de Clinicas da Universidade Federal do Parana ( Site 0104) — Curitiba, Paraná, Brazil
• Hospital Tacchini ( Site 0107) — Bento Gonçalves, Rio Grande do Sul, Brazil
• FUNFARME Hospital de Base Centro Integrado de Pesquisa ( Site 0101) — São José do Rio Preto, São Paulo, Brazil
• Kaiser Foundation Hospital - South Bay ( Site 1832) — Harbor City, California, United States

Full record on ClinicalTrials.gov

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