A Clinical Study of Molnupiravir to Prevent Severe Illness From Coronavirus Disease 2019 (COVID-19) in People Who Are High Risk (MK-4482-023)
- Conditions
- Coronavirus Disease (COVID-19)
- Interventions
- Drug: MolnupiravirDrug: Placebo
- Registration Number
- NCT06667700
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 3082
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Molnupiravir Molnupiravir Participants will receive 800 mg molnupiravir orally every 12 hours for 5 days (a total of 10 consecutive doses) Placebo Placebo Participants will receive molnupiravir-matching placebo orally every 12 hours for 5 days (a total of 10 consecutive doses)
- Primary Outcome Measures
Name Time Method 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) 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.
Percentage of Participants Who Experience an Adverse Event (AE) 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.
Percentage of Participants Who Discontinue Study Intervention Due to AE 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.
- Secondary Outcome Measures
Name Time Method Time to Sustained Alleviation Without Relapse of All 8 Selected COVID-19-related Signs/Symptoms Through Day 29 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.
Change from Baseline in Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Viral Load 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.
Percentage of Participants with Undetectable SARS-CoV-2 Viral Load 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.
Percentage of Participants Who Experienced One or More of Following Through Day 29: All-cause Hospitalization or All-cause Mortality 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.
Percentage of Participants With Clinically Important Medical Interventions (CIMI) Associated with COVID-19-related MAV or COVID-19-related Hospitalization Through Day 29 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.
Time to Sustained Alleviation Without Relapse of All 15 COVID-19-related Signs/Symptoms Through Day 29 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.
Time to Sustained Resolution Without Relapse of All 8 Selected COVID-19-related Signs/Symptoms Through Day 29 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.
Trial Locations
- Locations (150)
Tsuchiura Beryl Clinic ( Site 2009)
🇯🇵Tsuchiura, Ibaraki, Japan
Kumamoto Chuo Hospital ( Site 2002)
🇯🇵Kumamoto, Japan
Cullman Clinical Trials ( Site 3813)
🇺🇸Cullman, Alabama, United States
Helios Clinical Research ( Site 3826)
🇺🇸Paradise Valley, Arizona, United States
Absolute Clinical Research ( Site 3709)
🇺🇸Phoenix, Arizona, United States
Clinica de Salud del Valle de Salinas ( Site 3825)
🇺🇸Castroville, California, United States
Ascada Health PC dba Ascada Research ( Site 3750)
🇺🇸Fullerton, California, United States
Pacific Clinical Studies ( Site 3827)
🇺🇸Los Alamitos, California, United States
Valley Clinical Trials, Inc. ( Site 3707)
🇺🇸Northridge, California, United States
FOMAT Medical Research ( Site 3720)
🇺🇸Oxnard, California, United States
Paradigm Clinical Research, LLC ( Site 3785)
🇺🇸San Diego, California, United States
Optimus Medical ( Site 3817)
🇺🇸San Francisco, California, United States
Millennium Clinical Trials ( Site 3758)
🇺🇸Westlake Village, California, United States
Paradigm Clinical Research Centers, Inc ( Site 3718)
🇺🇸Wheat Ridge, Colorado, United States
Encore Medical Research of Boynton Beach ( Site 3701)
🇺🇸Boynton Beach, Florida, United States
Prestige Clinical Research Center ( Site 3722)
🇺🇸Coral Gables, Florida, United States
Indago Research & Health Center, Inc ( Site 3714)
🇺🇸Hialeah, Florida, United States
Prestige Clinical Research ( Site 3830)
🇺🇸Homestead, Florida, United States
Accel Research Sites Network - St. Pete-Largo Clinical Research Unit ( Site 3779)
🇺🇸Largo, Florida, United States
Clinical Site Partners, LLC dba Flourish Research ( Site 3717)
🇺🇸Leesburg, Florida, United States
Advanced Pulmonary Research Institute ( Site 3781)
🇺🇸Loxahatchee Groves, Florida, United States
Palm Springs Community Health Center ( Site 3757)
🇺🇸Miami Lakes, Florida, United States
Panax Clinical Research ( Site 3803)
🇺🇸Miami Lakes, Florida, United States
Southern Clinical Research ( Site 3773)
🇺🇸Miami, Florida, United States
Florida Pharmaceutical Research and Associates ( Site 3763)
🇺🇸Miami, Florida, United States
Bio-Medical Research LLC ( Site 3804)
🇺🇸Miami, Florida, United States
Bright Research Center ( Site 3746)
🇺🇸Miami, Florida, United States
Miami Clinical Research ( Site 3729)
🇺🇸Miami, Florida, United States
Reed Medical Research ( Site 3761)
🇺🇸Miami, Florida, United States
Combined Research Orlando Phase I-IV ( Site 3797)
🇺🇸Orlando, Florida, United States
CDC Research Institute ( Site 3716)
🇺🇸Port Saint Lucie, Florida, United States
New Tampa Health ( Site 3764)
🇺🇸Tampa, Florida, United States
Clinical Research Trials of Florida ( Site 3703)
🇺🇸Tampa, Florida, United States
Precision Research Center ( Site 3704)
🇺🇸Tampa, Florida, United States
Encore Medical Research - Weston ( Site 3708)
🇺🇸Weston, Florida, United States
Balanced Life Health Care Solutions/SKYCRNG ( Site 3713)
🇺🇸Lawrenceville, Georgia, United States
Renew Health Clinical Research ( Site 3760)
🇺🇸Snellville, Georgia, United States
Rophe Adult and Pediatric Medicine/SKYCRNG ( Site 3816)
🇺🇸Union City, Georgia, United States
Paradigm Clinical Research - Boise ( Site 3841)
🇺🇸Boise, Idaho, United States
University of Louisville School of Medicine ( Site 3706)
🇺🇸Louisville, Kentucky, United States
Barnum Medical Research ( Site 3828)
🇺🇸Natchitoches, Louisiana, United States
Annapolis Internal Medicine - CCT Research ( Site 3700)
🇺🇸Annapolis, Maryland, United States
Kur Research - Columbia Medical ( Site 3767)
🇺🇸Columbia, Maryland, United States
Revival Research Institute, LLC ( Site 3835)
🇺🇸Dearborn, Michigan, United States
Michigan Center of Medical Research (MICHMER) ( Site 3734)
🇺🇸Farmington Hills, Michigan, United States
Henry Ford St John TM Center for Infectious Disease Research ( Site 3766)
🇺🇸Grosse Pointe Woods, Michigan, United States
Mankato Clinic ( Site 3842)
🇺🇸Mankato, Minnesota, United States
Prime Health and Wellness/SKYCRNG ( Site 3726)
🇺🇸Fayette, Mississippi, United States
SKY Integrative Medical Center/SKYCRNG ( Site 3740)
🇺🇸Ridgeland, Mississippi, United States
Nevada Health Centers ( Site 3840)
🇺🇸Carson City, Nevada, United States
WR-CRCN, LLC ( Site 3818)
🇺🇸Las Vegas, Nevada, United States
Holy Name Medical Center ( Site 3807)
🇺🇸Teaneck, New Jersey, United States
Prime Global Research ( Site 3731)
🇺🇸Bronx, New York, United States
Weill Cornell Medical College ( Site 3814)
🇺🇸New York, New York, United States
OnSite Clinical Solutions ( Site 3784)
🇺🇸Charlotte, North Carolina, United States
Monroe Biomedical Research ( Site 3732)
🇺🇸Monroe, North Carolina, United States
IMA Clinical Research Mount Airy ( Site 3745)
🇺🇸Mount Airy, North Carolina, United States
Research Innovations, LLC ( Site 3712)
🇺🇸Beavercreek, Ohio, United States
Midlands Neurology & Pain Associates ( Site 3751)
🇺🇸Columbia, South Carolina, United States
Helios Clinical Research - JAC ( Site 3833)
🇺🇸Jackson, Tennessee, United States
Javara - Privia Medical Group Gulf Coast - The Woodlands HWH ( Site 3837)
🇺🇸Conroe, Texas, United States
South Texas Clinical Research ( Site 3815)
🇺🇸Corpus Christi, Texas, United States
Care United Research, LLC ( Site 3747)
🇺🇸Forney, Texas, United States
Andres Garcia Zuniga, M.D., P.A. ( Site 3782)
🇺🇸Laredo, Texas, United States
LinQ Research ( Site 3824)
🇺🇸Pearland, Texas, United States
Sekino Hospital ( Site 2016)
🇯🇵Toshimaku, Tokyo, Japan
Crossroads Clinical Research-Family Practice ( Site 3739)
🇺🇸Victoria, Texas, United States
Eastside Research Associates ( Site 3727)
🇺🇸Redmond, Washington, United States
CEMIC ( Site 0101)
🇦🇷Buenos Aires., Buenos Aires, Argentina
Hospital Italiano de Buenos Aires ( Site 0107)
🇦🇷Ciudad Autonoma de Buenos Aires., Buenos Aires, Argentina
Instituto de Investigaciones Clinicas Mar del Plata ( Site 0111)
🇦🇷Mar del Plata, Buenos Aires, Argentina
Medical Center Zdrave 1 ( Site 0509)
🇧🇬Kozloduy, Vratsa, Bulgaria
Medconsult Pleven - Lovech ( Site 0501)
🇧🇬Lovech, Bulgaria
Medical Center Hera ( Site 0507)
🇧🇬Montana, Bulgaria
Medconsult Pleven ( Site 0503)
🇧🇬Pleven, Bulgaria
DKC V - Plovdiv ( Site 0508)
🇧🇬Plovdiv, Bulgaria
Diagnostic Consultative Center 22 - Sofia ( Site 0500)
🇧🇬Sofia, Bulgaria
Medical Center Hera EOOD ( Site 0505)
🇧🇬Sofia, Bulgaria
MeVac - Meilahti Vaccine Research Center ( Site 1200)
🇫🇮Helsinki, Uusimaa, Finland
Centre Hospitalier Universitaire Dijon Bourgogne - Hôpital F-Centre d'Investigation Clinique - Plur
🇫🇷Dijon, Bourgogne, France
Pitie Salpetriere University Hospital-Infectious Disease - Tropical Diseases ( Site 1300)
🇫🇷Paris, Ile-de-France, France
CHU de Saint-Etienne ( Site 1302)
🇫🇷Saint Priest en Jarez, Loire, France
centre hospitalier lyon sud ( Site 1303)
🇫🇷Pierre-Bénite, Rhone, France
klinikum rechts der isar der technischen universität münchen ( Site 1502)
🇩🇪Munchen, Bayern, Germany
Universitätsklinikum Frankfurt Goethe-Universität ( Site 1503)
🇩🇪Frankfurt, Hessen, Germany
IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola ( Site 1904)
🇮🇹Bologna, Italy
Ospedale San Martino ( Site 1900)
🇮🇹Genova, Italy
ASST Fatebenefratelli Sacco ( Site 1901)
🇮🇹Milano, Italy
AOU Pisana- Ospedale Cisanello ( Site 1905)
🇮🇹Pisa, Italy
Wonju Severance Christian Hospital-Internal Medicine ( Site 3009)
🇰🇷Wonju, Kang-won-do, Korea, Republic of
Chonnam National University Hospital-Infectious Diseases ( Site 3008)
🇰🇷Gwangju-si, Kwangju-Kwangyokshi, Korea, Republic of
Korea University Ansan Hospital ( Site 3007)
🇰🇷Ansan-si, Kyonggi-do, Korea, Republic of
Gyeongsang National University Hospital ( Site 3005)
🇰🇷Jinju-si, Kyongsangnam-do, Korea, Republic of
Pusan National University Hospital-Internal Medicine ( Site 3010)
🇰🇷Pusan, Pusan-Kwangyokshi, Korea, Republic of
Kyungpook National University Chilgok Hospital-Division of Infectious Diseases ( Site 3002)
🇰🇷Deagu, Taegu-Kwangyokshi, Korea, Republic of
Korea University Anam Hospital ( Site 3001)
🇰🇷Seoul, Korea, Republic of
Hallym University Kangnam Sacred Heart Hospital-Internal Medicine ( Site 3003)
🇰🇷Seoul, Korea, Republic of
Korea University Guro Hospital ( Site 3006)
🇰🇷Seoul, Korea, Republic of
CGM Research Trust ( Site 2307)
🇳🇿Christchurch, Canterbury, New Zealand
Pacific Clinical Research Network - Tasman ( Site 2304)
🇳🇿Nelson, Tasman, New Zealand
Lakeland Clinical Trials Waikato ( Site 2302)
🇳🇿Nawton, Waikato, New Zealand
Lakeland Clinical Trials Wellington ( Site 2303)
🇳🇿Upper Hutt, Wellington, New Zealand
Pacific Clinical Research Network West Auckland ( Site 2301)
🇳🇿Auckland, New Zealand
Optimal Clinical Trials North ( Site 2308)
🇳🇿Auckland, New Zealand
Optimal Clinical Trials ( Site 2306)
🇳🇿Auckland, New Zealand
Przychodnia EuroMediCare, Wroclaw Lowiecka ( Site 2611)
🇵🇱Wrocław, Dolnoslaskie, Poland
NZOZ GynCentrum - Oddział Kraków ( Site 2609)
🇵🇱Krakow, Malopolskie, Poland
NZOZ GynCentrum - Oddział Bielsko-Biała ( Site 2602)
🇵🇱Bielsko-Biała, Slaskie, Poland
Clinical Medical Research ( Site 2604)
🇵🇱Katowice, Slaskie, Poland
Holsamed ( Site 2603)
🇵🇱Katowice, Slaskie, Poland
PL Certus ( Site 2613)
🇵🇱Poznan, Wielkopolskie, Poland
Investigadores del Este LLC ( Site 4001)
🇵🇷Humacao, Puerto Rico
Miralles Clinical Research LLC ( Site 4004)
🇵🇷San Juan, Puerto Rico
MV HEALTH SERVICES LLC ( Site 4003)
🇵🇷San Juan, Puerto Rico
Spitalul Clinic de Boli Infecțioase și Tropicale Victor Babeș ( Site 2701)
🇷🇴București, Bucuresti, Romania
Centrul Medical SANA ( Site 2704)
🇷🇴Bucuresti, Romania
Spitalul Clinic de Boli Infecțioase ( Site 2703)
🇷🇴Cluj, Romania
Spitalul Clinic de Boli Infecțioase ( Site 2702)
🇷🇴Constanta, Romania
Hospital General Universitario de Elche-Infectius Disease ( Site 3105)
🇪🇸Elche, Alicante, Spain
Hospital Germans Trias i Pujol ( Site 3101)
🇪🇸Badalona, Barcelona, Spain
EAP Osona Sud - Alt Congost S.L.P ( Site 3107)
🇪🇸Centelles, Barcelona, Spain
Hospital Universitari Vall d'Hebron ( Site 3102)
🇪🇸Barcelona, Cataluna, Spain
Hospital Santa Lucia-Medicina Infecciosas ( Site 3106)
🇪🇸Cartagena, Murcia, Spain
EAP Sardenya ( Site 3109)
🇪🇸Barcelona, Spain
Kaohsiung Medical University Chung-Ho Memorial Hospital ( Site 3306)
🇨🇳Kaoshiung, Kaohsiung, Taiwan
Taoyuan General Hospital ( Site 3300)
🇨🇳Taoyuan City, Taoyuan, Taiwan
Kaohsiung Veterans General Hospital ( Site 3307)
🇨🇳Kaohsiung, Taiwan
Taichung Veterans General Hospital ( Site 3305)
🇨🇳Taichung, Taiwan
National Taiwan University Hospital ( Site 3301)
🇨🇳Taipei, Taiwan
Tri-Service General Hospital ( Site 3304)
🇨🇳Taipei, Taiwan
Chang Gung Memorial Hospital - Linkou Branch ( Site 3303)
🇨🇳Taoyuan, Taiwan
EUROMEDCLINIC ( Site 3517)
🇺🇦Cherkasy, Cherkaska Oblast, Ukraine
MUNICIPAL NON-PROFIT ENTERPRISE CENTRAL CITY CLINICAL HOSPITAL OF CHERNIVTSI CITY COUNCIL ( Site 351
🇺🇦Chernivtsi, Chernihivska Oblast, Ukraine
Clinical medical and diagnostic center Limited Liability Company "Simedgroup" ( Site 3524)
🇺🇦Ivano-Frankivsk, Ivano-Frankivska Oblast, Ukraine
Regional Phthisiology and Pulmonology Center ( Site 3523)
🇺🇦Ivano-Frankivsk, Ivano-Frankivska Oblast, Ukraine
Private Enterprise Private Manufacturing Company Acinus-Medical and Diagnostic Centre ( Site 3537)
🇺🇦Kropyvnytskyi, Kirovohradska Oblast, Ukraine
Limited Liability Company Ukrainian Center of Tomotherapy-Clinical Trials Department ( Site 3512)
🇺🇦Kropyvnytskyi, Kirovohradska Oblast, Ukraine
Medical Center "Harmoniya Krasy" ( Site 3545)
🇺🇦Kyiv, Kyivska Oblast, Ukraine
Edelweiss Medics ( Site 3503)
🇺🇦Kyiv, Kyivska Oblast, Ukraine
Communal Non-Profit Enterprise "Kyiv City Clinical Hospital #1"-Department of Clinical Research ( Si
🇺🇦Kyiv, Kyivska Oblast, Ukraine
Medbud Clinic-Treatment prevention unit ( Site 3506)
🇺🇦Kyiv, Kyivska Oblast, Ukraine
Medical Center of Limited ( Site 3546)
🇺🇦Kyiv, Kyivska Oblast, Ukraine
Center of Family Medicine Plus ( Site 3502)
🇺🇦Kyiv, Kyivska Oblast, Ukraine
Polyclinic of Communal 4th city clinical hospital ( Site 3501)
🇺🇦Lviv, Lvivska Oblast, Ukraine
Municipal non-profit enterprise "Lviv Territorial Medical Union "Multidisciplinary Clinical Hospital
🇺🇦Lviv, Lvivska Oblast, Ukraine
Municipal Enterprise "Volyn Regional Clinical Hospital" of Volyn Regional Council ( Site 3530)
🇺🇦Lutsk, Volynska Oblast, Ukraine
Medlight Clinic ( Site 3548)
🇺🇦Kyiv, Ukraine
Kyiv Railway Clinical Hospital No.2 of Branch Health Center -Center of Clinical Trials ( Site 3549)
🇺🇦Kyiv, Ukraine
Royal Victoria Infirmary ( Site 3608)
🇬🇧Newcastle, Newcastle Upon Tyne, United Kingdom
Lakeside Surgery ( Site 3600)
🇬🇧Northamptonshire, United Kingdom