A Clinical Study of Molnupiravir to Prevent Severe Illness From Coronavirus Disease 2019 (COVID-19) in People Who Are High Risk (MK-4482-023)

Conditions

• Coronavirus Disease (COVID-19)

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Molnupiravir — DRUG
  Molnupiravir administered orally as two 400 mg film-coated tablets every 12 hours for 5 days (a total of 10 consecutive doses)
• Placebo — DRUG
  Molnupiravir-matching placebo administered orally as two film-coated tablets every 12 hours for 5 days (a total of 10 consecutive doses)

Study Details

Researchers are looking for other ways to prevent severe illness from COVID-19. COVID-19 is a virus that most often causes mild flu or cold-like symptoms. However, people with certain health conditions or other factors have a high risk (chance) of getting severely ill from COVID-19, which can require a hospital stay or lead to death. Some people who are high risk for severe illness may be unable to take certain treatments for COVID-19 because they are not available to them, or they take other medicines that may react with a treatment and cause an unwanted effect. Molnupiravir (MK-4482) is a study medicine designed to stop the COVID-19 virus from copying itself in the body (multiplying). The goal of this study is to learn if molnupiravir prevents severe illness from COVID-19 more than placebo in people who are high risk.

Key Dates

Start date

Dec 2, 2024

Status verified

Jun 2026

Primary completion

Jan 26, 2031

Completion

Jan 26, 2031

Study Design

Enrollment

3,082 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Molnupiravir
  Participants will receive 800 mg molnupiravir orally every 12 hours for 5 days (a total of 10 consecutive doses)
• Placebo Comparator: Placebo
  Participants will receive molnupiravir-matching placebo orally every 12 hours for 5 days (a total of 10 consecutive doses)

Primary Outcome Measure

Percentage of Participants Who Experienced One or More of Following Through Day 29: All-cause Hospitalization, All-cause Mortality, or Covid-19-related Medically-attended Visit (MAV) [ Time Frame: Up to 29 days ]

Central Contacts

• Toll Free Number
  1-888-577-8839
  [email protected]

Locations (71)

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