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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

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
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 4057835, Alabama 4829764 35055
Contact:
Study Coordinator
888-577-8839

Helios Clinical Research ( Site 3826)
Paradise Valley 5308049, Arizona 5551752 85253
Contact:
Study Coordinator
480-659-0448

Absolute Clinical Research ( Site 3709)
Phoenix 5308655, Arizona 5551752 85051
Contact:
Study Coordinator
888-577-8839

Clinica de Salud del Valle de Salinas ( Site 3825)
Castroville 5334937, California 5332921 95012
Contact:
Study Coordinator
805-483-1185

Ascada Health PC dba Ascada Research ( Site 3750)
Fullerton 5351247, California 5332921 92835
Contact:
Study Coordinator
888-577-8839

Pacific Clinical Studies ( Site 3827)
Los Alamitos 5368304, California 5332921 90720
Contact:
Study Coordinator
5625980600x205

Valley Clinical Trials, Inc. ( Site 3707)
Northridge 5377985, California 5332921 91325
Contact:
Study Coordinator
888-577-8839

FOMAT Medical Research ( Site 3720)
Oxnard 5380184, California 5332921 93030
Contact:
Study Coordinator
805-483-1185

Paradigm Clinical Research, LLC ( Site 3785)
San Diego 5391811, California 5332921 91208
Contact:
Study Coordinator
858274426

Optimus Medical ( Site 3817)
San Francisco 5391959, California 5332921 94102
Contact:
Study Coordinator
415-518-1292

Millennium Clinical Trials ( Site 3758)
Westlake Village 5408395, California 5332921 91361
Contact:
Study Coordinator
805-496-3322

Paradigm Clinical Research Centers, Inc ( Site 3718)
Wheat Ridge 5443948, Colorado 5417618 80033
Contact:
Study Coordinator
303-463-1947

Encore Medical Research of Boynton Beach ( Site 3701)
Boynton Beach 4148677, Florida 4155751 33436
Contact:
Study Coordinator
561-774-8799

Prestige Clinical Research Center ( Site 3722)
Coral Gables 4151871, Florida 4155751 33134
Contact:
Study Coordinator
305-907-6960

Indago Research & Health Center, Inc ( Site 3714)
Hialeah 4158476, Florida 4155751 33012
Contact:
Study Coordinator
305-825-6588

Prestige Clinical Research ( Site 3830)
Homestead 4159050, Florida 4155751 33030
Contact:
Study Coordinator
305-907-6961

Accel Research Sites Network - St. Pete-Largo Clinical Research Unit ( Site 3779)
Largo 4161580, Florida 4155751 33777
Contact:
Study Coordinator
727-347-8839

Clinical Site Partners, LLC dba Flourish Research ( Site 3717)
Leesburg 4161771, Florida 4155751 34748
Contact:
Study Coordinator
325-435-7240

Advanced Pulmonary Research Institute ( Site 3781)
Loxahatchee Groves 4162948, Florida 4155751 33470
Contact:
Study Coordinator
561-795-1022

Southern Clinical Research ( Site 3773)
Miami 4164138, Florida 4155751 33125
Contact:
Study Coordinator
888-577-8839

Florida Pharmaceutical Research and Associates ( Site 3763)
Miami 4164138, Florida 4155751 33143
Contact:
Study Coordinator
786-254-7296

Bio-Medical Research LLC ( Site 3804)
Miami 4164138, Florida 4155751 33144
Contact:
Study Coordinator
888-577-8839

Miami Clinical Research ( Site 3729)
Miami 4164138, Florida 4155751 33155
Contact:
Study Coordinator
888-577-8839

Reed Medical Research ( Site 3761)
Miami 4164138, Florida 4155751 33176
Contact:
Study Coordinator
305-413-0531

Palm Springs Community Health Center ( Site 3757)
Miami Lakes 4164186, Florida 4155751 33014
Contact:
Study Coordinator
888-577-8839

Panax Clinical Research ( Site 3803)
Miami Lakes 4164186, Florida 4155751 33014
Contact:
Study Coordinator
305-698-4500

Combined Research Orlando Phase I-IV ( Site 3797)
Orlando 4167147, Florida 4155751 32807
Contact:
Study Coordinator
407-440-4493

CDC Research Institute ( Site 3716)
Port Saint Lucie 4169171, Florida 4155751 34952
Contact:
Study Coordinator
888-577-8839

New Tampa Health ( Site 3764)
Tampa 4174757, Florida 4155751 33603
Contact:
Study Coordinator
813-440-6355

Clinical Research Trials of Florida ( Site 3703)
Tampa 4174757, Florida 4155751 33607
Contact:
Study Coordinator
888-577-8839

Precision Research Center ( Site 3704)
Tampa 4174757, Florida 4155751 33614
Contact:
Study Coordinator
813-513-2365

Encore Medical Research - Weston ( Site 3708)
Weston 4178003, Florida 4155751 33331
Contact:
Study Coordinator
888-577-8839

Balanced Life Health Care Solutions/SKYCRNG ( Site 3713)
Lawrenceville 4205196, Georgia 4197000 30046
Contact:
Study Coordinator
770-696-4541

Renew Health Clinical Research ( Site 3760)
Snellville 4223413, Georgia 4197000 30078
Contact:
Study Coordinator
888-577-8839

Rophe Adult and Pediatric Medicine/SKYCRNG ( Site 3816)
Union City 4227777, Georgia 4197000 30291
Contact:
Study Coordinator
470-317-3604

Paradigm Clinical Research - Boise ( Site 3841)
Boise 5586437, Idaho 5596512 83709
Contact:
Study Coordinator
208-801-7440

University of Louisville School of Medicine ( Site 3706)
Louisville 4299276, Kentucky 6254925 40202
Contact:
Study Coordinator
888-577-8839

Annapolis Internal Medicine - CCT Research ( Site 3700)
Annapolis 4347242, Maryland 4361885 21401
Contact:
Study Coordinator
888-577-8839

Kur Research - Columbia Medical ( Site 3767)
Columbia 4352053, Maryland 4361885 21045
Contact:
Study Coordinator
410-964-8522

Revival Research Institute, LLC ( Site 3835)
Dearborn 4990510, Michigan 5001836 48126
Contact:
Study Coordinator
888-577-8839

Michigan Center of Medical Research (MICHMER) ( Site 3734)
Farmington Hills 4992523, Michigan 5001836 48334
Contact:
Study Coordinator
248-747-4383

Henry Ford St John TM Center for Infectious Disease Research ( Site 3766)
Grosse Pointe Woods 4994871, Michigan 5001836 48236
Contact:
Study Coordinator
888-577-8839

Mankato Clinic ( Site 3842)
Mankato 5036420, Minnesota 5037779 56001
Contact:
Study Coordinator
507-625-1811

Prime Health and Wellness/SKYCRNG ( Site 3726)
Fayette 4426218, Mississippi 4436296 39069
Contact:
Study Coordinator
888-577-8839

SKY Integrative Medical Center/SKYCRNG ( Site 3740)
Ridgeland 4443296, Mississippi 4436296 39157
Contact:
Study Coordinator
888-577-8839

Nevada Health Centers ( Site 3840)
Carson City 5501344, Nevada 5509151 89706
Contact:
Study Coordinator
770-200-9775

WR-CRCN, LLC ( Site 3818)
Las Vegas 5506956, Nevada 5509151 89106
Contact:
Study Coordinator
702-893-8968

Saint Michael's Medical Center ( Site 3808)
Newark 5101798, New Jersey 5101760 07102
Contact:
Study Coordinator
973-877-5162

Holy Name Medical Center ( Site 3807)
Teaneck 5105262, New Jersey 5101760 07666
Contact:
Study Coordinator
201-833-3000

Weill Cornell Medical College ( Site 3814)
New York 5128581, New York 5128638 10065
Contact:
Study Coordinator
888-577-8839

Prime Global Research ( Site 3731)
The Bronx 5110266, New York 5128638 10456
Contact:
Study Coordinator
718-676-9444

OnSite Clinical Solutions ( Site 3784)
Charlotte 4460243, North Carolina 4482348 28277
Contact:
Study Coordinator
888-577-8839

Monroe Biomedical Research ( Site 3732)
Monroe 4479946, North Carolina 4482348 28112
Contact:
Study Coordinator
888-577-8839

IMA Clinical Research Mount Airy ( Site 3745)
Mount Airy 4480378, North Carolina 4482348 27030
Contact:
Study Coordinator
336-415-5507

Research Innovations, LLC ( Site 3712)
Beavercreek 4506008, Ohio 5165418 45431
Contact:
Study Coordinator
937-986-1851

Midlands Neurology & Pain Associates ( Site 3751)
Columbia 4575352, South Carolina 4597040 29205
Contact:
Study Coordinator
888-577-8839

Helios Clinical Research - JAC ( Site 3833)
Jackson 4632595, Tennessee 4662168 38305
Contact:
Study Coordinator
731-431-5027

Javara - Privia Medical Group Gulf Coast - The Woodlands HWH ( Site 3837)
Conroe 4682991, Texas 4736286 77384
Contact:
Study Coordinator
281-639-5061

South Texas Clinical Research ( Site 3815)
Corpus Christi 4683416, Texas 4736286 78404
Contact:
Study Coordinator
888-577-8839

Care United Research, LLC ( Site 3747)
Forney 4691833, Texas 4736286 75126
Contact:
Study Coordinator
9725640044x240

Houston Methodist Hospital ( Site 3800)
Houston 4699066, Texas 4736286 77030
Contact:
Study Coordinator
713-441-3250

Andres Garcia Zuniga, M.D., P.A. ( Site 3782)
Laredo 4705349, Texas 4736286 78041
Contact:
Study Coordinator
956-307-4280

LinQ Research ( Site 3824)
Pearland 4718097, Texas 4736286 77584
Contact:
Study Coordinator
281-916-4220

Crossroads Clinical Research-Family Practice ( Site 3739)
Victoria 4739157, Texas 4736286 77901
Contact:
Study Coordinator
361-574-7800

Velocity Clinical Research - Hampton ( Site 3744)
Hampton 4762894, Virginia 6254928 23666
Contact:
Study Coordinator
757-520-5111

Eastside Research Associates ( Site 3727)
Redmond 5808079, Washington 5815135 98052
Contact:
Study Coordinator
425-869-6828

Investigadores del Este LLC ( Site 4001)
Humacao 4565564, Puerto Rico 00791
Contact:
Study Coordinator
787 656 0161

Miralles Clinical Research LLC ( Site 4004)
San Juan 4568127, Puerto Rico 00921
Contact:
Study Coordinator
787 226 1014

MV HEALTH SERVICES LLC ( Site 4003)
San Juan 4568127, Puerto Rico 00926
Contact:
Study Coordinator
787 365 2102

More Details

NCT ID
NCT06667700
Status
Recruiting
Sponsor
Merck Sharp & Dohme LLC

Study Contact

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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.