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

NCT06667700
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Phase
Phase 3
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Recruitment status
Recruiting
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Participants
3,082
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Lead sponsor
Merck Sharp & Dohme LLC
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Start date
2024-12-02
clinicaltrials.gov
Number of sites
224
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Summary
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.
clinicaltrials.gov
Acronym
MOVe-NOW
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Short title
A Clinical Study of Molnupiravir to Prevent Severe Illness From Coronavirus Disease 2019 (COVID-19) in People Who Are High Risk (MK-4482-023)
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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
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Control arm
Placebo
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Recruiting
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Phase
Phase 3
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Study type
Interventional
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Completion date
2031-01-26
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First posted
2024-10-31
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Registry last updated
2026-08-28
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Primary completion date
2031-01-26
clinicaltrials.gov
Start date
2024-12-02
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Participants
3,082
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Participant count basis
Estimated
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Planned participants
3,082
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Protocol amendments
2
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Number of sites
224
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Data monitoring committee
Yes
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Registry sponsor category
Industry
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Lead sponsor
Merck Sharp & Dohme LLC
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Source registry
ClinicalTrials.gov
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Registry ID
NCT06667700
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ClinicalTrials.gov ID
NCT06667700
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
Double masking
Masked roles
Participants, Investigators
Sources for study design
clinicaltrials.gov

  1. 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)

    Timeframe: Up to 29 days

    Hospitalization is defined as ≥24 hours of acute care in a hospital or similar acute care facility, including emergency rooms or facilities created to address hospitalization needs specifically for COVID-19. Hospitalization and death may be due to any cause. An MAV is defined as any unscheduled, nonroutine healthcare visit where the participant is evaluated by a licensed (according to local/national guidelines) healthcare provider. As prespecified by the protocol, the percentage of participants who experience ONE OR MORE of these 3 events (hospitalization, death, or COVID-19-related MAV) occurring from randomization through Day 29 will be presented.

  2. Percentage of Participants Who Experienced an Adverse Event (AE)

    Timeframe: Up to approximately 5 months

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The percentage of participants with at least 1 AE will be presented.

  3. Percentage of Participants Who Discontinued Study Intervention Due to AE

    Timeframe: Up to approximately 5 days

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The percentage of participants who discontinue study intervention due to an AE will be presented.

  1. Time to Sustained Alleviation (without relapse) of all selected 8 (5 prespecified and 3 determined by baseline prevalence), self-reported COVID-19 signs/symptoms

    Timeframe: Up to 29 days

    Time to sustained alleviation without relapse is defined as the number of days from randomization to the first of 2 consecutive days when alleviation (lessening of symptoms) is demonstrated, collectively, for all 8 selected COVID-19-related sign/symptoms. Participants who experience sustained alleviation for 2 consecutive days must not relapse in any of the 8 signs/symptoms before Day 29. The time to sustained alleviation without relapse of all 8 selected COVID-19-related signs/symptoms from randomization through Day 29 will be presented.

  2. Change from Baseline in Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) RNA Titer

    Timeframe: Day 1 (baseline) and up to Day 29

    SARS-CoV-2 RNA titer (viral load) will be measured by quantitative reverse transcriptase polymerase chain reaction (RT-PCR) of samples from nasopharyngeal (NP) swabs, and the mean change from baseline will be presented.

  3. Percentage of Participants with Undetectable SARS-CoV-2 RNA

    Timeframe: Up to 29 days

    SARS-CoV-2 RNA (viral load) will be measured by quantitative RT-PCR of samples from NP swabs, and the percentage of participants with undetectable (i.e., below the lower limit of quantification) SARS-CoV-2 RNA (viral load) will be presented.

  4. Percentage of Participants Who Experienced One or More of Following Through Day 29: All-cause Hospitalization or All-cause Mortality

    Timeframe: Up to 29 days

    Hospitalization is defined as ≥24 hours of acute care in a hospital or similar acute care facility, including emergency rooms or facilities created to address hospitalization needs specifically for COVID-19. Hospitalization and death may be due to any cause. As prespecified by the protocol, the percentage of participants who experience hospitalization AND/OR death occurring from randomization through Day 29 will be presented.

  5. Percentage of Participants With Clinically Important Medical Interventions (CIMI) Associated with COVID-19-related MAV or COVID-19-related Hospitalization Through Day 29

    Timeframe: Up to 29 days

    CIMIs were prespecified by the protocol and include, but are not limited to, supplemental oxygen therapy, IV fluid administration, and nebulizer treatment. An MAV is defined as any unscheduled, nonroutine healthcare visit where the participant is evaluated by a licensed (according to local/national guidelines) healthcare provider. Hospitalization is defined as ≥24 hours of acute care in a hospital or similar acute care facility, including emergency rooms or facilities created to address hospitalization needs specifically for COVID-19. The percentage of participants with CIMIs associated with a COVID-19-related MAV AND/OR a COVID-19-related hospitalization through Day 29 will be reported.

  6. Time to Sustained Alleviation (without relapse) of all 15 self-reported COVID-19 signs/symptoms through Day 29

    Timeframe: Up to 29 days

    Time to sustained alleviation without relapse is defined as the number of days from randomization to the first of 2 consecutive days when alleviation (lessening of symptoms) is demonstrated, collectively, for all 15 COVID-19-related sign/symptoms. Participants who experience sustained alleviation after 2 consecutive days must not relapse in any of the 15 signs/symptoms before Day 29. The time to sustained alleviation without relapse of all 15 COVID-19-related signs/symptoms from randomization through Day 29 will be presented.

  7. 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

    Timeframe: Up to 29 days

    Time to sustained resolution without relapse is defined as the number of days from randomization to the first of 2 consecutive days when resolution (having no symptoms or only mild symptoms) is demonstrated, collectively, for all 8 selected COVID-19-related sign/symptoms. Participants who experience sustained resolution after 2 consecutive days must not relapse in any of the 8 signs/symptoms before Day 29. The time to sustained resolution without relapse of all 8 selected COVID-19-related signs/symptoms from randomization through Day 29 will be presented.

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
No

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.

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

Sources for eligibility
clinicaltrials.gov

  • Cullman Clinical Trials ( Site 3813)Cullman, United StatesCompleted
  • Helios Clinical Research ( Site 3826)Paradise Valley, United StatesRecruiting
  • Absolute Clinical Research ( Site 3709)Phoenix, United StatesCompleted
  • Clinica de Salud del Valle de Salinas ( Site 3825)Castroville, United StatesRecruiting
  • Ascada Health PC dba Ascada Research ( Site 3750)Fullerton, United StatesCompleted
  • Pacific Clinical Studies ( Site 3827)Los Alamitos, United StatesRecruiting
  • Valley Clinical Trials, Inc. ( Site 3707)Northridge, United StatesRecruiting
  • FOMAT Medical Research ( Site 3720)Oxnard, United StatesRecruiting
  • Paradigm Clinical Research, LLC ( Site 3785)San Diego, United StatesRecruiting
  • Optimus Medical ( Site 3817)San Francisco, United StatesRecruiting
  • Millennium Clinical Trials ( Site 3758)Westlake Village, United StatesRecruiting
  • Paradigm Clinical Research Centers, Inc ( Site 3718)Wheat Ridge, United StatesRecruiting
  • Encore Medical Research of Boynton Beach ( Site 3701)Boynton Beach, United StatesRecruiting
  • Prestige Clinical Research Center ( Site 3722)Coral Gables, United StatesRecruiting
  • Prestige Clinical Research ( Site 3830)Homestead, United StatesRecruiting
  • Accel Research Sites Network - St. Pete-Largo Clinical Research Unit ( Site 3779)Largo, United StatesRecruiting
  • Clinical Site Partners, LLC dba Flourish Research ( Site 3717)Leesburg, United StatesRecruiting
  • Advanced Pulmonary Research Institute ( Site 3781)Loxahatchee Groves, United StatesRecruiting
  • Southern Clinical Research ( Site 3773)Miami, United StatesRecruiting
  • Florida Pharmaceutical Research and Associates ( Site 3763)Miami, United StatesRecruiting
  • Bio-Medical Research LLC ( Site 3804)Miami, United StatesRecruiting
  • Bright Research Center ( Site 3746)Miami, United StatesCompleted
  • Miami Clinical Research ( Site 3729)Miami, United StatesRecruiting
  • Reed Medical Research ( Site 3761)Miami, United StatesRecruiting
  • Palm Springs Community Health Center ( Site 3757)Miami Lakes, United StatesRecruiting

And 199 more, listed on the interactive page.

Sources for sites
clinicaltrials.gov

  • MK-4482-023
  • 2023
  • U1111-1295-4678
  • 2023-507227-36-00
  • jRCT2031250022
Sources for references
clinicaltrials.gov

Related records

Drugs (1)

Lead sponsors (1)

Conditions (1)