Recruiting NCT06667700

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

Phase III Interventional Coronavirus Disease (COVID-19)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: Molnupiravir, Placebo.
Who it may be relevant to: Registry conditions: Coronavirus Disease (COVID-19). Basic parameters: from 18 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: United States, Argentina, Brazil, Bulgaria, Colombia +19
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

Drug Molnupiravir
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)

Primary outcome measures

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]
Percentage of Participants Who Experienced an Adverse Event (AE) [Time frame: Up to approximately 5 months]
Percentage of Participants Who Discontinued Study Intervention Due to AE [Time frame: Up to approximately 5 days]

Secondary outcome measures (7)

Time to Sustained Alleviation (without relapse) of all selected 8 (5 prespecified and 3 determined by baseline prevalence), self-reported COVID-19 signs/symptoms [Time frame: Up to 29 days]
Change from Baseline in Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) RNA Titer [Time frame: Day 1 (baseline) and up to Day 29]
Percentage of Participants with Undetectable SARS-CoV-2 RNA [Time frame: Up to 29 days]
Percentage of Participants Who Experienced One or More of Following Through Day 29: All-cause Hospitalization or All-cause Mortality [Time frame: Up to 29 days]
Percentage of Participants With Clinically Important Medical Interventions (CIMI) Associated with COVID-19-related MAV or COVID-19-related Hospitalization Through Day 29 [Time frame: Up to 29 days]
Time to Sustained Alleviation (without relapse) of all 15 self-reported COVID-19 signs/symptoms through Day 29 [Time frame: Up to 29 days]
Time to Sustained Resolution Without Relapse of all 8 (5 prespecified and 3 determined by baseline prevalence) self-reported COVID-19 signs/symptoms through Day 29 [Time frame: Up to 29 days]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation: Randomized
Model: Parallel assignment
Masking: Double blind
Primary purpose: Treatment