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A Phase 3, Randomized, Placebo-Controlled, Double-Blind Clinical Study to Evaluate the Efficacy and Safety of Molnupiravir (MK-4482) in Non-Hospitalized Adults With COVID-19 at High Risk for Disease Progression

MK-4482 Phase 3 Study in Non-Hospitalized Adults With COVID-19 at High Risk for Disease Progression

Kobayashi Masayuki

MSD K.K.

KITANOMARU SQUARE,1-13-12,Kudan-kita,Chiyoda-ku,Tokyo 102-8667,Japan

msdjrct@msd.com

MSDJRCT inquiry mailbox

MSD K.K.

KITANOMARU SQUARE,1-13-12,Kudan-kita,Chiyoda-ku,Tokyo 102-8667,Japan

+81-3-6272-1957

msdjrct@msd.com

Recruiting

June. 16, 2025

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

treatment purpose

1) Is an individual of any sex/gender, >=18 years of age
2) Has documentation of SARS-CoV-2 infection with sample collection <=4 days prior to randomization
3) 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 degrees or chills, nausea or vomiting or diarrhea, change in sense of smell or change in sense of taste, or headache
4) 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
5) 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 >=35, diabetes)
6) Is unable 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 renal or hepatic impairment
- Has experienced prior adverse reactions or hepatotoxicity to NMV/r that would preclude future use
- Has uncontrolled HIV infection
- Has known or suspected NMV/r resistance
- NMV/r is not approved/authorized in the participant's country or it is not accessible to participant (e.g., drug shortage)

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.

1) Is currently hospitalized or is expected to need hospitalization for COVID-19 imminently
2) Has received or plans to receive SARS-CoV-2 directed antivirals or monoclonal antibodies for current episode of COVID-19 (other than study intervention and, if applicable, remdesivir as standard of care)
3) 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
- Is receiving >4 liters/minute supplemental oxygen for COVID-19 (but was not receiving supplemental oxygen prior to COVID-19), regardless of SpO2
4) Has received a COVID-19 vaccine within 30 days prior to randomization
5) Has a history of SARS-CoV-2 infection (with or without symptoms) within 30 days prior to randomization
6) Has known or suspected hypersensitivity to active or inactive ingredients of molnupiravir

Both

Coronavirus Disease (COVID-19)

- Drug: Molnupiravir (MK-4482)
Molnupiravir administered orally as two 400 mg film-coated tablets every 12 hours for 5 days (a total of 10 consecutive doses)
- Drug: Placebo
Molnupiravir-matching placebo administered orally as two film-coated tablets every 12 hours for 5 days (a total of 10 consecutive doses)

- 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)
- Percentage of Participants Who Experience an Adverse Event (AE) [Time Frame: Up to 5 months]
- Percentage of Participants Who Discontinue Study Intervention Due to AE [Time Frame: Up to 5 days]

- Time to Sustained Alleviation Without Relapse of All 8 Selected COVID-19-related Signs/Symptoms Through Day 29
- Change from Baseline in Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Viral Load [Time frame: Day 1 and up to Day 29]
- Percentage of Participants with Undetectable SARS-CoV-2 Viral Load [Time frame: up to Day 29]
- Percentage of Participants Who Experienced One or More of Following Through Day 29: All-cause Hospitalization or All-cause Mortality
- Percentage of Participants With Clinically Important Medical Interventions (CIMI) Associated with COVID-19-related MAV or COVID-19-related Hospitalization Through Day 29
- Time to Sustained Alleviation Without Relapse of All 15 COVID-19-related Signs/Symptoms Through Day 29
- Time to Sustained Resolution Without Relapse of All 8 Selected COVID-19-related Signs/Symptoms Through Day 29

+81-3-3986-5501

Jan. 17, 2025

Yes

https://engagezone.msd.com/wp-content/uploads/sites/518/2025/02/ProcedureAccessClinicalTrialData.pdf

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