Skip to main content
UK clinical trials - updated daily from ClinicalTrials.gov
TrialConnect
← Back to Search
Looking for participantsPhase3

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

Sponsor: Merck Sharp & Dohme LLC

NCT ID: NCT06667700

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Molnupiravir (drug), Placebo (drug)
How long the study runs
Study runs about 73 months (dates as stated)
About the drug or intervention
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)
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
18 Years and over
Who
All
Number of participants
3,082
Started
2024-12-02
Last checked
2026-10

Plain English Summary

What is this study?

  • • Testing a new treatment for coronavirus disease (covid-19)
  • • Phase3 - 3,082 participants
  • • Researchers are looking for other ways to prevent severe illness from COVID-19

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with coronavirus disease (covid-19)

Where?

  • • Bristol - Whiteladies Medical Group ( Site 3611)
  • • Exeter - Royal Devon & Exeter Hospital ( Site 3604)
  • • Newcastle - Royal Victoria Infirmary ( Site 3608)
  • • Norwich - Norwich Practices Health Centre ( Site 3605)
  • • +5 more UK sites

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

Coronavirus Disease (COVID-19)

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: All genders

What the study is looking for

  • ✓Inclusion Criteria
  • ✓The main inclusion criteria include but are not limited to the following:
  • ✓Is an individual of any sex/gender, ≥18 years of age
  • ✓Has documentation of SARS-CoV-2 infection with sample collection ≤4 days prior to randomization
  • ✓Has ≥1 of the following characteristics or medical conditions associated with the highest risk of severe illness...
See the full criteria
Inclusion Criteria The main inclusion criteria include but are not limited to the following: * Is an individual of any sex/gender, ≥18 years of age * Has documentation of SARS-CoV-2 infection with sample collection ≤4 days prior to randomization * Has initial onset of signs/symptoms attributable to COVID-19 for ≤4 days prior to the day of randomization and ≥2 of the following signs/symptoms attributable to COVID-19 on the day of randomization: cough, sore throat, nasal congestion, shortness of breath or difficulty breathing with exertion, muscle or body aches, fatigue, fever \>38.0°C or chills, nausea or vomiting or diarrhea, change in sense of smell or change in sense of taste, or headache * Has ≥1 of the following characteristics or medical conditions associated with the highest risk of severe illness from COVID-19: * Advanced age of ≥75 years of age * Immunocompromised * Neurocognitive or physical disability * Has ≥3 characteristics or medical conditions which increase the risk of severe illness due to COVID-19 (e.g., chronic lung disease, obesity with body mass index (BMI) ≥35, diabetes) * Is unable or unwilling to receive treatment with nirmatrelvir/ritonavir (NMV/r) due to 1 or more of the following: * Is receiving drug(s) highly dependent on cytochrome P450 3A (CYP3A) for clearance and for which elevated concentrations are associated with serious and/or life-threatening consequences or drug(s) with a clinically significant drug-drug interaction for which co-administration is not possible * Is receiving potent CYP3A inducers where significantly reduced nirmatrelvir or ritonavir plasma concentrations may be associated with the potential for loss of virologic response and possible resistance * Has severe hepatic impairment * Has experienced prior adverse reactions or hepatotoxicity to NMV/r that would preclude future use * Has known or suspected NMV/r resistance * Has uncontrolled HIV infection * NMV/r is not approved/authorized in the participant's country or it is not accessible to participant (e.g., drug shortage) * Is unwilling to receive treatment with NMV/r Inclusion note: Participants may receive remdesivir as standard of care in addition to molnupiravir or placebo. If remdesivir is available and clinically appropriate per local clinical practice, investigators will aim to ensure that those who are most vulnerable to severe COVID-19 receive timely access to remdesivir as standard of care on this study. Exclusion Criteria The main exclusion criteria include but are not limited to the following: * Is currently hospitalized or is expected to need hospitalization for COVID-19 imminently * Has received or plans to receive SARS-CoV-2 directed oral antivirals or monoclonal antibodies for current episode of COVID-19 (other than study intervention and, if applicable, remdesivir as standard of care) * Has ≥1 of the following signs/symptoms that are attributable to severe or critical COVID-19: * Shortness of breath at rest * Respiratory rate ≥30 breaths per minute * Heart rate ≥125 beats per minute * Peripheral oxygen saturation (SpO2) ≤93% on room air or on supplemental oxygen for a reason other than COVID-19 which has not increased since onset of COVID-19 signs/symptoms * New or increasing need for supplemental oxygen: receiving \>4 liters/minute supplemental oxygen due to COVID-19 OR on supplemental oxygen for a reason other than COVID-19 which has increased due to COVID-19 * Has received a COVID-19 vaccine within 30 days prior to randomization * Has a history of confirmed influenza, respiratory syncytial virus (RSV), or SARS-CoV-2 infection (with or without symptoms; excluding current infection) within 30 days prior to randomization * Has known or suspected hypersensitivity to active or inactive ingredients of molnupiravir

Where Is This Study? (9 UK sites)

Whiteladies Medical Group ( Site 3611)

Bristol BS8 2PU, United Kingdom

Recruiting
Site contact (verified)
Study Coordinator01179731201

Royal Devon & Exeter Hospital ( Site 3604)

Exeter EX2 5DW, United Kingdom

Recruiting
Site contact (verified)
Study Coordinator01392411611

Royal Victoria Infirmary ( Site 3608)

Newcastle NE1 4LP, United Kingdom

Recruiting
Site contact (verified)
Study Coordinator+441912336161

Norwich Practices Health Centre ( Site 3605)

Norwich NR1 1RB, United Kingdom

Recruiting
Site contact (verified)
Study Coordinator+4407552431271

Oak Street Medical Practice ( Site 3612)

Norwich NR3 3DL, United Kingdom

Recruiting
Site contact (verified)
Study Coordinator+441603613431

Lakeside Surgery ( Site 3600)

Northamptonshire NN17 2UR, United Kingdom

Recruiting
Site contact (verified)
Study Coordinator+441536748282

Bicester Health Centre ( Site 3609)

Bicester OX26 6AT, United Kingdom

Recruiting
Site contact (verified)
Study Coordinator01869 249333

Banbury Cross Health Centre ( Site 3610)

Oxford OX16 9AD, United Kingdom

Recruiting
Site contact (verified)
Study Coordinator0

Buttercross Health Centre ( Site 3606)

Somerset TA11 7PB, United Kingdom

Recruiting
Site contact (verified)
Study Coordinator+441458272473

How to Get in Touch

Toll Free Number

Sponsor contact

CONTACT

1-888-577-8839 Trialsites@msd.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-10