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Clinical trial of molnupiravir (MK-4482) in adults who have COVID-19 and are not hospitalized, who are at high risk for serious illness from the infection.
EU CTIS ID: 2023-507227-36-00
What this study is testing
1. To evaluate the efficacy of MOV compared with placebo as assessed by the percentage of participants in the mITT population who have one or more of the following from randomization through Day 29: hospitalization (all-cause), death (all-cause), or a COVID-19-related MAV. 2. To evaluate the safety and tolerability of MOV compared with the placebo in the APaT population.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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: 1) advanced age of ≥75 years of age, 2) Immunocompromised, 3) Neurocognitive or physical disability or has ≥3 characteristics or medical conditions which increase the risk of severe illness due to COVID-19 (e.g. diabetes, obesity with body mass index (BMI) ≥ 35, chronic lung diseases)
- Is unable or unwilling to receive treatment with nirmatrelvir/ritonavir (NMV/r) due to 1 or more of the following: 1) Is receiving drug(s) highly dependent on cytochrome P450 (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, 2) Is receiving potent CYP3A inducers where significantly reduces nirmatrelvir or ritonavir plasma concentrations may be associated with the potential for loss of virologic response and possible resistance, 3) Has severe hepatic impairment, 4) Has experienced prior adverse reactions or hepatotoxicity to NMV/r that would preclude future use, 5) Has known or suspected NMV/r resistance, 6) Has uncontrolled HIV infection, 7) NMV/r is not approved/authorized in the participant’s country or it is not accessible to participant (e.g. drug shortage), 8) Is unwilling to receive treatment with NMV/r
You likely can't join if
- 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: 1) shortness of breath at rest, 2) respiratory rate ≥30 breaths per minute, 3) heart rate ≥125 beats per minute, 4) 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, 5) New or increasing need for supplemental oxygen: Receiving >4 liters/min 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 MOV
The study team makes the final eligibility decision.
Where it's taking place
- Colombia
- New Zealand
- Japan
- Philippines
- Egypt
- Peru
- Ukraine
- Thailand
- United States
- Puerto Rico
- Georgia
- Argentina
- Taiwan
- Korea, Republic of
- United Kingdom
- Mexico
- Brazil
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Colombia; New Zealand; Japan; Philippines; Egypt; Peru and 11 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.