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

Purpose

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.

Condition

  • Coronavirus Disease (COVID-19)

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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 ≥35, diabetes) - 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.

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 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 - Is receiving >4 liters/minute supplemental oxygen for COVID-19 (but was not receiving supplemental oxygen prior to COVID-19), regardless of SpO2 - Has received a COVID-19 vaccine within 30 days prior to randomization - Has a history of SARS-CoV-2 infection (with or without symptoms) within 30 days prior to randomization - Has known or suspected hypersensitivity to active or inactive ingredients of molnupiravir

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Molnupiravir
Participants will receive 800 mg molnupiravir orally every 12 hours for 5 days (a total of 10 consecutive doses)
  • Drug: Molnupiravir
    Molnupiravir administered orally as two 400 mg film-coated tablets every 12 hours for 5 days (a total of 10 consecutive doses)
    Other names:
    • MK-4482
    • LAGEVRIO®
Placebo Comparator
Placebo
Participants will receive molnupiravir-matching placebo orally 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)

Recruiting Locations

Cullman Clinical Trials ( Site 3813)
Cullman, Alabama 35055
Contact:
Study Coordinator
888-577-8839

Helios Clinical Research ( Site 3826)
Paradise Valley, Arizona 85253
Contact:
Study Coordinator
480-659-0448

Absolute Clinical Research ( Site 3709)
Phoenix, Arizona 85051
Contact:
Study Coordinator
888-577-8839

Clinica de Salud del Valle de Salinas ( Site 3825)
Castroville, California 95012
Contact:
Study Coordinator
805-483-1185

Ascada Health PC dba Ascada Research ( Site 3750)
Fullerton, California 92835
Contact:
Study Coordinator
888-577-8839

Pacific Clinical Studies ( Site 3827)
Los Alamitos, California 90720
Contact:
Study Coordinator
5625980600x205

Valley Clinical Trials, Inc. ( Site 3707)
Northridge, California 91325
Contact:
Study Coordinator
888-577-8839

FOMAT Medical Research ( Site 3720)
Oxnard, California 93030
Contact:
Study Coordinator
805-483-1185

Paradigm Clinical Research, LLC ( Site 3785)
San Diego, California 91208
Contact:
Study Coordinator
858274426

Optimus Medical ( Site 3817)
San Francisco, California 94102
Contact:
Study Coordinator
415-518-1292

Millennium Clinical Trials ( Site 3758)
Westlake Village, California 91361
Contact:
Study Coordinator
805-496-3322

Paradigm Clinical Research Centers, Inc ( Site 3718)
Wheat Ridge, Colorado 80033
Contact:
Study Coordinator
303-463-1947

Encore Medical Research of Boynton Beach ( Site 3701)
Boynton Beach, Florida 33436
Contact:
Study Coordinator
561-774-8799

Prestige Clinical Research Center ( Site 3722)
Coral Gables, Florida 33134
Contact:
Study Coordinator
305-907-6960

Indago Research & Health Center, Inc ( Site 3714)
Hialeah, Florida 33012
Contact:
Study Coordinator
305-825-6588

Prestige Clinical Research ( Site 3830)
Homestead, Florida 33030
Contact:
Study Coordinator
305-907-6961

Accel Research Sites Network - St. Pete-Largo Clinical Research Unit ( Site 3779)
Largo, Florida 33777
Contact:
Study Coordinator
727-347-8839

Clinical Site Partners, LLC dba Flourish Research ( Site 3717)
Leesburg, Florida 34748
Contact:
Study Coordinator
325-435-7240

Advanced Pulmonary Research Institute ( Site 3781)
Loxahatchee Groves, Florida 33470
Contact:
Study Coordinator
561-795-1022

Palm Springs Community Health Center ( Site 3757)
Miami Lakes, Florida 33014
Contact:
Study Coordinator
888-577-8839

Panax Clinical Research ( Site 3803)
Miami Lakes, Florida 33014
Contact:
Study Coordinator
305-698-4500

Southern Clinical Research ( Site 3773)
Miami, Florida 33125
Contact:
Study Coordinator
888-577-8839

Florida Pharmaceutical Research and Associates ( Site 3763)
Miami, Florida 33143
Contact:
Study Coordinator
786-254-7296

Bio-Medical Research LLC ( Site 3804)
Miami, Florida 33144
Contact:
Study Coordinator
888-577-8839

Bright Research Center ( Site 3746)
Miami, Florida 33144
Contact:
Study Coordinator
888-577-8839

Miami Clinical Research ( Site 3729)
Miami, Florida 33155
Contact:
Study Coordinator
888-577-8839

Reed Medical Research ( Site 3761)
Miami, Florida 33176
Contact:
Study Coordinator
305-413-0531

Combined Research Orlando Phase I-IV ( Site 3797)
Orlando, Florida 32807
Contact:
Study Coordinator
407-440-4493

CDC Research Institute ( Site 3716)
Port Saint Lucie, Florida 34952
Contact:
Study Coordinator
888-577-8839

New Tampa Health ( Site 3764)
Tampa, Florida 33603
Contact:
Study Coordinator
813-440-6355

Clinical Research Trials of Florida ( Site 3703)
Tampa, Florida 33607
Contact:
Study Coordinator
888-577-8839

Precision Research Center ( Site 3704)
Tampa, Florida 33614
Contact:
Study Coordinator
813-513-2365

Encore Medical Research - Weston ( Site 3708)
Weston, Florida 33331
Contact:
Study Coordinator
888-577-8839

Balanced Life Health Care Solutions/SKYCRNG ( Site 3713)
Lawrenceville, Georgia 30046
Contact:
Study Coordinator
770-696-4541

Renew Health Clinical Research ( Site 3760)
Snellville, Georgia 30078
Contact:
Study Coordinator
888-577-8839

Rophe Adult and Pediatric Medicine/SKYCRNG ( Site 3816)
Union City, Georgia 30291
Contact:
Study Coordinator
470-317-3604

Paradigm Clinical Research - Boise ( Site 3841)
Boise, Idaho 83709
Contact:
Study Coordinator
208-801-7440

University of Louisville School of Medicine ( Site 3706)
Louisville, Kentucky 40202
Contact:
Study Coordinator
888-577-8839

Barnum Medical Research ( Site 3828)
Natchitoches, Louisiana 71457
Contact:
Study Coordinator
318-352-9880

Annapolis Internal Medicine - CCT Research ( Site 3700)
Annapolis, Maryland 21401
Contact:
Study Coordinator
888-577-8839

Kur Research - Columbia Medical ( Site 3767)
Columbia, Maryland 21045
Contact:
Study Coordinator
410-964-8522

Revival Research Institute, LLC ( Site 3835)
Dearborn, Michigan 48126
Contact:
Study Coordinator
888-577-8839

Michigan Center of Medical Research (MICHMER) ( Site 3734)
Farmington Hills, Michigan 48334
Contact:
Study Coordinator
248-747-4383

Henry Ford St John TM Center for Infectious Disease Research ( Site 3766)
Grosse Pointe Woods, Michigan 48236
Contact:
Study Coordinator
888-577-8839

Mankato Clinic ( Site 3842)
Mankato, Minnesota 56001
Contact:
Study Coordinator
507-625-1811

Prime Health and Wellness/SKYCRNG ( Site 3726)
Fayette, Mississippi 39069
Contact:
Study Coordinator
888-577-8839

SKY Integrative Medical Center/SKYCRNG ( Site 3740)
Ridgeland, Mississippi 39157
Contact:
Study Coordinator
888-577-8839

Nevada Health Centers ( Site 3840)
Carson City, Nevada 89706
Contact:
Study Coordinator
770-200-9775

WR-CRCN, LLC ( Site 3818)
Las Vegas, Nevada 89106
Contact:
Study Coordinator
702-893-8968

Holy Name Medical Center ( Site 3807)
Teaneck, New Jersey 07666
Contact:
Study Coordinator
201-833-3000

Prime Global Research ( Site 3731)
Bronx, New York 10456
Contact:
Study Coordinator
718-676-9444

Weill Cornell Medical College ( Site 3814)
New York, New York 10065
Contact:
Study Coordinator
888-577-8839

OnSite Clinical Solutions ( Site 3784)
Charlotte, North Carolina 28277
Contact:
Study Coordinator
888-577-8839

Monroe Biomedical Research ( Site 3732)
Monroe, North Carolina 28112
Contact:
Study Coordinator
888-577-8839

IMA Clinical Research Mount Airy ( Site 3745)
Mount Airy, North Carolina 27030
Contact:
Study Coordinator
336-415-5507

Research Innovations, LLC ( Site 3712)
Beavercreek, Ohio 45431
Contact:
Study Coordinator
937-986-1851

Midlands Neurology & Pain Associates ( Site 3751)
Columbia, South Carolina 29205
Contact:
Study Coordinator
888-577-8839

Helios Clinical Research - JAC ( Site 3833)
Jackson, Tennessee 38305
Contact:
Study Coordinator
731-431-5027

Javara - Privia Medical Group Gulf Coast - The Woodlands HWH ( Site 3837)
Conroe, Texas 77384
Contact:
Study Coordinator
281-639-5061

South Texas Clinical Research ( Site 3815)
Corpus Christi, Texas 78404
Contact:
Study Coordinator
888-577-8839

Care United Research, LLC ( Site 3747)
Forney, Texas 75126
Contact:
Study Coordinator
9725640044x240

Andres Garcia Zuniga, M.D., P.A. ( Site 3782)
Laredo, Texas 78041
Contact:
Study Coordinator
956-307-4280

LinQ Research ( Site 3824)
Pearland, Texas 77584
Contact:
Study Coordinator
281-916-4220

Crossroads Clinical Research-Family Practice ( Site 3739)
Victoria, Texas 77901
Contact:
Study Coordinator
361-574-7800

Eastside Research Associates ( Site 3727)
Redmond, Washington 98052
Contact:
Study Coordinator
425-869-6828

Investigadores del Este LLC ( Site 4001)
Humacao, Puerto Rico 00791
Contact:
Study Coordinator
1-888-577-8839

Miralles Clinical Research LLC ( Site 4004)
San Juan, Puerto Rico 00921
Contact:
Study Coordinator
1-888-577-8839

MV HEALTH SERVICES LLC ( Site 4003)
San Juan, Puerto Rico 00926
Contact:
Study Coordinator
1-888-577-8839

More Details

NCT ID
NCT06667700
Status
Recruiting
Sponsor
Merck Sharp & Dohme LLC

Study Contact

Toll Free Number
1-888-577-8839
Trialsites@msd.com