AzTrials
AzTrials

Coronavirus Disease (COVID-19)Phase 3MOVe-NOWNCT06667700

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

A Phase 3 study testing Molnupiravir in people with Coronavirus Disease (COVID-19), run by Merck Sharp & Dohme LLC at 227 sites in 24 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Coronavirus Disease (COVID-19)
What is being tested?
Molnupiravir
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
3,082 participants
Where
227 sitesin 24 countries
Study dates
2 Dec 2024to 26 Jan 2031
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 19Show fewer
  • 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.

Who cannot join

  • 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
Show all 12Show fewer
  • 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

Trial locations and contacts

227 sites in 24 countries. Contact the study team or a site near you to ask about taking part.

Toll Free Number contact

1-888-577-8839

Trialsites@msd.com

227 sites in 24 countries

United States71 sites, 55 recruiting

  • Annapolis Internal Medicine - CCT Research ( Site 3700)

    Annapolis, Maryland, 21401

    Study Coordinator, 410-824-1005

    Recruiting

  • Research Innovations, LLC ( Site 3712)

    Beavercreek, Ohio, 45431

    Completed

  • Paradigm Clinical Research - Boise ( Site 3841)

    Boise, Idaho, 83709

    Completed

  • Encore Medical Research of Boynton Beach ( Site 3701)

    Boynton Beach, Florida, 33436

    Study Coordinator, 561-774-8799

    Recruiting

  • Nevada Health Centers ( Site 3840)

    Carson City, Nevada, 89706

    Study Coordinator, 770-200-9775

    Recruiting

  • Clinica de Salud del Valle de Salinas ( Site 3825)

    Castroville, California, 95012

    Study Coordinator, 805-483-1185

    Recruiting

  • OnSite Clinical Solutions ( Site 3784)

    Charlotte, North Carolina, 28277

    Study Coordinator, 800-785-3150

    Recruiting

  • Rush University Medical Center ( Site 3748)

    Chicago, Illinois, 60612

    Study Coordinator, 312-942-5987

    Recruiting

  • Kur Research - Columbia Medical ( Site 3767)

    Columbia, Maryland, 21045

    Study Coordinator, 410-964-8522

    Recruiting

  • Midlands Neurology & Pain Associates ( Site 3751)

    Columbia, South Carolina, 29205

    Active, not recruiting

  • Javara - Privia Medical Group Gulf Coast - The Woodlands HWH ( Site 3837)

    Conroe, Texas, 77384

    Study Coordinator, 281-639-5061

    Recruiting

  • Prestige Clinical Research Center ( Site 3722)

    Coral Gables, Florida, 33134

    Study Coordinator, 305-907-6960

    Recruiting

  • South Texas Clinical Research ( Site 3815)

    Corpus Christi, Texas, 78404

    Study Coordinator, 361-288-4668

    Recruiting

  • Cullman Clinical Trials ( Site 3813)

    Cullman, Alabama, 35055

    Completed

  • Revival Research Institute, LLC ( Site 3835)

    Dearborn, Michigan, 48126

    Completed

  • Michigan Center of Medical Research (MICHMER) ( Site 3734)

    Farmington Hills, Michigan, 48334

    Completed

  • Prime Health and Wellness/SKYCRNG ( Site 3726)

    Fayette, Mississippi, 39069

    Completed

  • Care United Research, LLC ( Site 3747)

    Forney, Texas, 75126

    Active, not recruiting

  • Ascada Health PC dba Ascada Research ( Site 3750)

    Fullerton, California, 92835

    Completed

  • Henry Ford St John TM Center for Infectious Disease Research ( Site 3766)

    Grosse Pointe Woods, Michigan, 48236

    Study Coordinator, 313-343-6311

    Recruiting

  • Velocity Clinical Research - Hampton ( Site 3744)

    Hampton, Virginia, 23666

    Completed

  • Prestige Clinical Research ( Site 3830)

    Homestead, Florida, 33030

    Study Coordinator, 305-907-6961

    Recruiting

  • Houston Methodist Hospital ( Site 3800)

    Houston, Texas, 77030

    Study Coordinator, 713-441-3250

    Recruiting

  • MD Anderson ( Site 3843)

    Houston, Texas, 77030

    Study Coordinator, 713-792-6830

    Recruiting

  • Helios Clinical Research - JAC ( Site 3833)

    Jackson, Tennessee, 38305

    Study Coordinator, 731-431-5027

    Recruiting

  • Andres Garcia Zuniga, M.D., P.A. ( Site 3782)

    Laredo, Texas, 78041

    Study Coordinator, 956-307-4280

    Recruiting

  • Accel Research Sites Network - St. Pete-Largo Clinical Research Unit ( Site 3779)

    Largo, Florida, 33777

    Study Coordinator, 727-347-8839

    Recruiting

  • WR-CRCN, LLC ( Site 3818)

    Las Vegas, Nevada, 89106

    Study Coordinator, 702-893-8968

    Recruiting

  • Balanced Life Health Care Solutions/SKYCRNG ( Site 3713)

    Lawrenceville, Georgia, 30046

    Study Coordinator, 770-696-4541

    Recruiting

  • Clinical Site Partners, LLC dba Flourish Research ( Site 3717)

    Leesburg, Florida, 34748

    Study Coordinator, 325-435-7240

    Recruiting

  • Duly Health and Care ( Site 3799)

    Lombard, Illinois, 60148

    Study Coordinator, 630-545-7760

    Recruiting

  • Pacific Clinical Studies ( Site 3827)

    Los Alamitos, California, 90720

    Study Coordinator, 5625980600x205

    Recruiting

  • University of Louisville School of Medicine ( Site 3706)

    Louisville, Kentucky, 40202

    Study Coordinator, 502-852-3836

    Recruiting

  • Advanced Pulmonary Research Institute ( Site 3781)

    Loxahatchee Groves, Florida, 33470

    Active, not recruiting

  • Mankato Clinic ( Site 3842)

    Mankato, Minnesota, 56001

    Study Coordinator, 507-625-1811

    Recruiting

  • Southern Clinical Research ( Site 3773)

    Miami, Florida, 33125

    Study Coordinator, 844-312-1727

    Recruiting

  • Florida Pharmaceutical Research and Associates ( Site 3763)

    Miami, Florida, 33143

    Study Coordinator, 786-254-7296

    Recruiting

  • Bio-Medical Research LLC ( Site 3804)

    Miami, Florida, 33144

    Study Coordinator, 305-671-3686

    Recruiting

  • Bright Research Center ( Site 3746)

    Miami, Florida, 33144

    Completed

  • Miami Clinical Research ( Site 3729)

    Miami, Florida, 33155

    Study Coordinator, 305-433-6496

    Recruiting

  • Reed Medical Research ( Site 3761)

    Miami, Florida, 33176

    Study Coordinator, 305-413-0531

    Recruiting

  • Palm Springs Community Health Center ( Site 3757)

    Miami Lakes, Florida, 33014

    Study Coordinator, 786-334-6675

    Recruiting

  • Panax Clinical Research ( Site 3803)

    Miami Lakes, Florida, 33014

    Study Coordinator, 305-698-4500

    Recruiting

  • Indago Research and Health Center Inc ( Site 3714)

    Miami Lakes, Florida, 33016

    Study Coordinator, 305-825-6588

    Recruiting

  • Monroe Biomedical Research ( Site 3732)

    Monroe, North Carolina, 28112

    Study Coordinator, 704-283-7359

    Recruiting

  • IMA Clinical Research Mount Airy ( Site 3745)

    Mount Airy, North Carolina, 27030

    Study Coordinator, 336-415-5507

    Recruiting

  • Barnum Medical Research ( Site 3828)

    Natchitoches, Louisiana, 71457

    Completed

  • Weill Cornell Medical College ( Site 3814)

    New York, New York, 10065

    Study Coordinator, 212-746-7587

    Recruiting

  • Saint Michael's Medical Center ( Site 3808)

    Newark, New Jersey, 07102

    Study Coordinator, 973-877-5162

    Recruiting

  • Valley Clinical Trials, Inc. ( Site 3707)

    Northridge, California, 91325

    Study Coordinator, 818-280-4220

    Recruiting

  • Combined Research Orlando Phase I-IV ( Site 3797)

    Orlando, Florida, 32807

    Study Coordinator, 407-440-4493

    Recruiting

  • FOMAT Medical Research ( Site 3720)

    Oxnard, California, 93030

    Study Coordinator, 805-483-1185

    Recruiting

  • Helios Clinical Research ( Site 3826)

    Paradise Valley, Arizona, 85253

    Study Coordinator, 480-659-0448

    Recruiting

  • LinQ Research ( Site 3824)

    Pearland, Texas, 77584

    Study Coordinator, 281-916-4220

    Recruiting

  • Absolute Clinical Research ( Site 3709)

    Phoenix, Arizona, 85051

    Completed

  • CDC Research Institute ( Site 3716)

    Port Saint Lucie, Florida, 34952

    Study Coordinator, 772-807-1636

    Recruiting

  • Eastside Research Associates ( Site 3727)

    Redmond, Washington, 98052

    Study Coordinator, 425-869-6828

    Recruiting

  • SKY Integrative Medical Center/SKYCRNG ( Site 3740)

    Ridgeland, Mississippi, 39157

    Study Coordinator, 601-617-7717

    Recruiting

  • Paradigm Clinical Research, LLC ( Site 3785)

    San Diego, California, 91208

    Study Coordinator, 858274426

    Recruiting

  • Optimus Medical ( Site 3817)

    San Francisco, California, 94102

    Study Coordinator, 415-518-1292

    Recruiting

  • Renew Health Clinical Research ( Site 3760)

    Snellville, Georgia, 30078

    Study Coordinator, 706-223-3560

    Recruiting

  • New Tampa Health ( Site 3764)

    Tampa, Florida, 33603

    Study Coordinator, 813-440-6355

    Recruiting

  • Clinical Research Trials of Florida ( Site 3703)

    Tampa, Florida, 33607

    Study Coordinator, 813-873-8102

    Recruiting

  • Precision Research Center ( Site 3704)

    Tampa, Florida, 33614

    Study Coordinator, 813-513-2365

    Recruiting

  • Holy Name Medical Center ( Site 3807)

    Teaneck, New Jersey, 07666

    Study Coordinator, 201-833-3000

    Recruiting

  • Prime Global Research ( Site 3731)

    The Bronx, New York, 10456

    Study Coordinator, 718-676-9444

    Recruiting

  • Rophe Adult and Pediatric Medicine/SKYCRNG ( Site 3816)

    Union City, Georgia, 30291

    Completed

  • Crossroads Clinical Research-Family Practice ( Site 3739)

    Victoria, Texas, 77901

    Study Coordinator, 361-574-7800

    Recruiting

  • Millennium Clinical Trials ( Site 3758)

    Westlake Village, California, 91361

    Study Coordinator, 805-496-3322

    Recruiting

  • Encore Medical Research - Weston ( Site 3708)

    Weston, Florida, 33331

    Completed

  • Paradigm Clinical Research Centers, Inc ( Site 3718)

    Wheat Ridge, Colorado, 80033

    Study Coordinator, 303-463-1947

    Recruiting

Other trials in United States

Ukraine20 sites, 19 recruiting

  • EUROMEDCLINIC ( Site 3517)

    Cherkasy, Cherkasy Oblast, 18021

    Study Coordinator, +380966684934

    Recruiting

  • MUNICIPAL NON-PROFIT ENTERPRISE CENTRAL CITY CLINICAL HOSPITAL OF CHERNIVTSI CITY COUNCIL ( Site 3513)

    Chernivtsi, Chernivetska Oblast, 58000

    Study Coordinator, 380501835097

    Recruiting

  • Clinical medical and diagnostic center Limited Liability Company "Simedgroup" ( Site 3524)

    Ivano-Frankivsk, Ivano-Frankivsk Oblast, 76008

    Study Coordinator, +380669779646

    Recruiting

  • Regional Phthisiology and Pulmonology Center ( Site 3523)

    Ivano-Frankivsk, Ivano-Frankivsk Oblast, 76018

    Study Coordinator, +380503383383

    Recruiting

  • Private Enterprise Private Manufacturing Company Acinus-Medical and Diagnostic Centre ( Site 3537)

    Kropyvnytskyi, Kirovohrad Oblast, 25006

    Study Coordinator, +380522 366002

    Recruiting

  • Limited Liability Company Ukrainian Center of Tomotherapy-Clinical Trials Department ( Site 3512)

    Kropyvnytskyi, Kirovohrad Oblast, 25011

    Study Coordinator, +38 095 8718674

    Recruiting

  • Medical Center "Harmoniya Krasy" ( Site 3545)

    Kyiv, Kyivska Oblast, 01135

    Study Coordinator, +380936306646

    Recruiting

  • Edelweiss Medics ( Site 3503)

    Kyiv, Kyivska Oblast, 02002

    Study Coordinator, +380504446557

    Recruiting

  • Communal Non-Profit Enterprise "Kyiv City Clinical Hospital #1"-Department of Clinical Research ( Site 3514)

    Kyiv, Kyivska Oblast, 02091

    Study Coordinator, +38 044 5611708

    Recruiting

  • Medbud Clinic-Treatment prevention unit ( Site 3506)

    Kyiv, Kyivska Oblast, 03037

    Study Coordinator, +380503572250

    Recruiting

  • Medical Center of Limited ( Site 3546)

    Kyiv, Kyivska Oblast, 04050

    Study Coordinator, +380969949971

    Recruiting

  • Center of Family Medicine Plus ( Site 3502)

    Kyiv, Kyivska Oblast, 04210

    Study Coordinator, +380509084116

    Recruiting

  • Medlight Clinic ( Site 3548)

    Kyiv, 02222

    Study Coordinator, +38 067 46632

    Recruiting

  • Kyiv Railway Clinical Hospital No.2 of Branch Health Center -Center of Clinical Trials ( Site 3549)

    Kyiv, 03049

    Study Coordinator, +380509165888

    Recruiting

  • Municipal Enterprise "Volyn Regional Clinical Hospital" of Volyn Regional Council ( Site 3530)

    Lutsk, Volyn Oblast, 43005

    Study Coordinator, +380958969484

    Recruiting

  • Polyclinic of Communal 4th city clinical hospital ( Site 3501)

    Lviv, Lviv Oblast, 79011

    Study Coordinator, +380504727692

    Recruiting

  • Lviv Territorial Medical Union Multidisciplinary Clinical Hospital ( Site 3525)

    Lviv, Lviv Oblast, 79059

    Suspended

  • Uzhhorod Municipal Multidisciplinary Clinical Hospital of Uzhhorod City Council ( Site 3538)

    Uzhhorod, Zakarpattia Oblast, 88000

    Study Coordinator, 380664959049

    Recruiting

  • University clinic of the National Pirogov Memorial Medical University ( Site 3547)

    Vinnytsia, Vinnytsia Oblast, 21001

    Study Coordinator, +380965363123

    Recruiting

  • Clinic of Scientific and Research Institute of Invalid Rehabilitation of VNMU n.a. M.I.Pyrohov ( Site 3528)

    Vinnytsia, Vinnytsia Oblast, 21029

    Study Coordinator, +380673978046

    Recruiting

Other trials in Ukraine

Bulgaria12 sites, 12 recruiting

  • Medical Center 'Medconsult' Burgas EOOD ( Site 0510)

    Burgas, 8000

    Study Coordinator, +359879886842

    Recruiting

  • Medical Center Zdrave 1 ( Site 0509)

    Kozloduy, Vratsa, 3320

    Study Coordinator, +359878619077

    Recruiting

  • Medconsult Pleven - Lovech ( Site 0501)

    Lovech, 5500

    Study Coordinator, +35968629195

    Recruiting

  • Medical Center Hera ( Site 0507)

    Montana, 3400

    Study Coordinator, +35032261110

    Recruiting

  • MHAT "Dr. Stamen Iliev" Montana-Department of Pulmonology ( Site 0504)

    Montana, 3403

    Study Coordinator, +35996306881

    Recruiting

  • Medconsult Pleven ( Site 0503)

    Pleven, 5800

    Study Coordinator, +35964910999

    Recruiting

  • DKC V - Plovdiv ( Site 0508)

    Plovdiv, 4023

    Study Coordinator, 032261110

    Recruiting

  • SHATPPD Dr. Dimitar Gramatikov - Ruse EOOD ( Site 0502)

    Rousse, 7002

    Study Coordinator, +35982813961

    Recruiting

  • Diagnostic Consultative Center 22 - Sofia ( Site 0500)

    Sofia, 1113

    Study Coordinator, +3528929840

    Recruiting

  • Medical Center Hera EOOD ( Site 0505)

    Sofia, 1510

    Study Coordinator, 359882441433

    Recruiting

  • Medical Centre Pratia Clinic EOOD ( Site 0511)

    Varna, 9020

    Study Coordinator, +359882655182

    Recruiting

  • Medical Center Asclepius ( Site 0506)

    Velingrad, Pazardzhik, 4600

    Study Coordinator, +35935952561

    Recruiting

Other trials in Bulgaria

Poland10 sites, 10 recruiting

  • NZOZ GynCentrum - Oddział Bielsko-Biała ( Site 2602)

    Bielsko-Biala, Silesian Voivodeship, 43-300

    Study Coordinator, +48327241012

    Recruiting

  • In-Vivo Bydgoszcz ( Site 2601)

    Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-048

    Study Coordinator, 48723351053

    Recruiting

  • FutureMeds Gdynia ( Site 2621)

    Gdynia, Pomeranian Voivodeship, 81-384

    Study Coordinator, +48585065410

    Recruiting

  • Clinical Medical Research ( Site 2604)

    Katowice, Silesian Voivodeship, 40-156

    Study Coordinator, +48327248013

    Recruiting

  • Holsamed ( Site 2603)

    Katowice, Silesian Voivodeship, 40-600

    Study Coordinator, +48327241012

    Recruiting

  • NZOZ GynCentrum - Oddział Kraków ( Site 2609)

    Krakow, Lesser Poland Voivodeship, 31-322

    Study Coordinator, +48327241012

    Recruiting

  • Centrum Medyczne FutureMeds ( Site 2615)

    Lodz, Łódź Voivodeship, 91-363

    Study Coordinator, +48530546417

    Recruiting

  • PL Certus ( Site 2613)

    Poznan, Greater Poland Voivodeship, 60-309

    Study Coordinator, 48734217034

    Recruiting

  • Futuremeds Targowek ( Site 2619)

    Warsaw, Masovian Voivodeship, 03-291

    Study Coordinator, +48502921680

    Recruiting

  • Penta Hospitals Przychodnie Wrocław Wejherowska ( Site 2611)

    Wroclaw, Lower Silesian Voivodeship, 54-239

    Study Coordinator, 48713957541

    Recruiting

Other trials in Poland

South Korea9 sites, 9 recruiting

  • Korea University Ansan Hospital ( Site 3007)

    Ansan-si, Kyonggi-do, 15355

    Study Coordinator, 82-31-412-5011

    Recruiting

  • Kyungpook National University Chilgok Hospital-Division of Infectious Diseases ( Site 3002)

    Deagu, Taegu-Kwangyokshi, 41404

    Study Coordinator, 82-53-200-2616

    Recruiting

  • Chonnam National University Hospital-Infectious Diseases ( Site 3008)

    Gwangju, Kwangju-Kwangyokshi, 61469

    Study Coordinator, 82-62-220-6295

    Recruiting

  • Gyeongsang National University Hospital ( Site 3005)

    Jinju, Kyongsangnam-do, 52727

    Study Coordinator, +82557508055

    Recruiting

  • Pusan National University Hospital-Internal Medicine ( Site 3010)

    Pusan, Pusan-Kwangyokshi, 49241

    Study Coordinator, +82-51-240-8592

    Recruiting

  • Korea University Anam Hospital ( Site 3001)

    Seoul, 02841

    Study Coordinator, 82-2-920-5096

    Recruiting

  • Hallym University Kangnam Sacred Heart Hospital-Internal Medicine ( Site 3003)

    Seoul, 07441

    Study Coordinator, +8228295106

    Recruiting

  • Korea University Guro Hospital ( Site 3006)

    Seoul, 08308

    Study Coordinator, +82226263052

    Recruiting

  • Wonju Severance Christian Hospital-Internal Medicine ( Site 3009)

    Wŏnju, Kang-won-do, 26426

    Study Coordinator, +82-33-741-0519

    Recruiting

Other trials in South Korea

Spain9 sites, 9 recruiting

  • Hospital Universitario de A Coruña ( Site 3112)

    A Coruña, Galicia, 15006

    Study Coordinator, 34 981 17 81 57

    Recruiting

  • Hospital Germans Trias i Pujol ( Site 3101)

    Badalona, Barcelona, 08916

    Study Coordinator, +34934978349

    Recruiting

  • Hospital Universitari Vall d'Hebron ( Site 3102)

    Barcelona, Catalonia, 08035

    Study Coordinator, +34934896090

    Recruiting

  • EAP Sardenya ( Site 3109)

    Barcelona, 08025

    Study Coordinator, +34935674385

    Recruiting

  • Hospital Santa Lucia-Medicina Infecciosas ( Site 3106)

    Cartagena, Murcia, 30202

    Study Coordinator, +34968110471

    Recruiting

  • EAP Osona Sud - Alt Congost S.L.P ( Site 3107)

    Centelles, Barcelona, 08540

    Study Coordinator, +34938810485

    Recruiting

  • Hospital General Universitario de Elche-Infectius Disease ( Site 3105)

    Elche, Alicante, 03202

    Study Coordinator, +34966616754

    Recruiting

  • Hospital Universitario Infanta Leonor ( Site 3110)

    Madrid, 28031

    Study Coordinator, 34911918280

    Recruiting

  • HOSPITAL UNIVERSITARIO VIRGEN DEL ROCIO ( Site 3100)

    Seville, 41013

    Study Coordinator, +34697958658

    Recruiting

Other trials in Spain

Taiwan9 sites, 9 recruiting

  • Kaohsiung Veterans General Hospital ( Site 3307)

    Kaohsiung City, 813

    Study Coordinator, +88673422121x72187

    Recruiting

  • Kaohsiung Medical University Chung-Ho Memorial Hospital ( Site 3306)

    Kaoshiung, Kaohsiung, 807

    Study Coordinator, +88673121101

    Recruiting

  • Taipei Medical University - Shuang Ho Hospital ( Site 3308)

    New Taipei City, 23561

    Study Coordinator, +88622249-0088

    Recruiting

  • Taichung Veterans General Hospital ( Site 3305)

    Taichung, 40705

    Study Coordinator, +886423592525x6523

    Recruiting

  • National Taiwan University Hospital ( Site 3301)

    Taipei, 10002

    Study Coordinator, +886-2-2312-3456

    Recruiting

  • Tri-Service General Hospital ( Site 3304)

    Taipei, 114

    Study Coordinator, +886287923311x13655

    Recruiting

  • Taipei Municipal Wangfang Hospital ( Site 3309)

    Taipei, 11696

    Study Coordinator, +886229307930

    Recruiting

  • Chang Gung Memorial Hospital - Linkou Branch ( Site 3303)

    Taoyuan, 333

    Study Coordinator, +88633281200x8450

    Recruiting

  • Taoyuan General Hospital ( Site 3300)

    Taoyuan City, Taoyuan, 33004

    Study Coordinator, +88633699721x8311

    Recruiting

Other trials in Taiwan

United Kingdom9 sites, 9 recruiting

  • Bicester Health Centre ( Site 3609)

    Bicester, Oxfordshire, OX26 6AT

    Study Coordinator, 01869 249333

    Recruiting

  • Whiteladies Medical Group ( Site 3611)

    Bristol, Bristol, City of, BS8 2PU

    Study Coordinator, 01179731201

    Recruiting

  • Royal Devon & Exeter Hospital ( Site 3604)

    Exeter, England, EX2 5DW

    Study Coordinator, 01392411611

    Recruiting

  • Royal Victoria Infirmary ( Site 3608)

    Newcastle, Newcastle Upon Tyne, NE1 4LP

    Study Coordinator, +441912336161

    Recruiting

  • Lakeside Surgery ( Site 3600)

    Northamptonshire, Northamptonshire, NN17 2UR

    Study Coordinator, +441536748282

    Recruiting

  • Norwich Practices Health Centre ( Site 3605)

    Norwich, Norfolk, NR1 1RB

    Study Coordinator, +4407552431271

    Recruiting

  • Oak Street Medical Practice ( Site 3612)

    Norwich, Norfolk, NR3 3DL

    Study Coordinator, +441603613431

    Recruiting

  • Banbury Cross Health Centre ( Site 3610)

    Oxford, Oxfordshire, OX16 9AD

    Study Coordinator, 0

    Recruiting

  • Buttercross Health Centre ( Site 3606)

    Somerset, Somerset, TA11 7PB

    Study Coordinator, +441458272473

    Recruiting

Other trials in United Kingdom

Georgia8 sites, 7 recruiting

  • Clinic Health - Batumi ( Site 1405)

    Batumi, Adjara, 6000

    Study Coordinator, +995591409090

    Recruiting

  • Family Medical Regional Center ( Site 1404)

    Batumi, Adjara, 6000

    Suspended

  • LTD High Technology Hospital Medcenter ( Site 1408)

    Batumi, Adjara, 6010

    Study Coordinator, +995596226060

    Recruiting

  • University Clinic of Innovative Medicine ( Site 1400)

    Batumi, Adjara, 6010

    Study Coordinator, +995 422 25 20 08

    Recruiting

  • Caucasus Medical Centre ( Site 1406)

    Tbilisi, Adjara, 0186

    Study Coordinator, +995322600600

    Recruiting

  • New Hospitals ( Site 1409)

    Tbilisi, 0114

    Study Coordinator, +995 322 190 190

    Recruiting

  • Curatio Clinic - Main Location ( Site 1401)

    Tbilisi, 0186

    Study Coordinator, +995 32 243 01 01

    Recruiting

  • "Georgian Clinics" JSC ( Site 1410)

    Zugdidi, Samegrelo and Zemo Svaneti, 2100

    Study Coordinator, +995577733383

    Recruiting

Other trials in Georgia

Mexico8 sites, 8 recruiting

  • ICARO Investigaciones en Medicina ( Site 2200)

    Chihuahua City, 31000

    Study Coordinator, +526144106319

    Recruiting

  • Instituto Nacional de Salud Publica ( Site 2205)

    Cuernavaca, Morelos, 62100

    Study Coordinator, +52 777 102 84 44

    Recruiting

  • CIO - Centro de Inmuno-Oncología de Occidente ( Site 2207)

    Guadalajara, Jalisco, 44630

    Study Coordinator, +523330447001

    Recruiting

  • Morales Vargas Centro de Investigacion S. C. ( Site 2206)

    León, Guanajuato, 37000

    Study Coordinator, +52 477 716 0714

    Recruiting

  • Centro Multidisciplinario para el Desarrollo Especializado de la Investigacion Clinica en Yucatan ( Site 2202)

    Mérida, Yucatán, 97130

    Study Coordinator, +529991929912

    Recruiting

  • Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran-Departamento de Infectología ( Site 2203)

    Mexico City, Mexico City, 14080

    Study Coordinator, +52525554870900

    Recruiting

  • Hospital Universitario "Dr. Jose Eleuterio Gonzalez"-Infectologia ( Site 2204)

    Monterrey, Nuevo León, 64460

    Study Coordinator, +52 8181230812

    Recruiting

  • Arké SMO S.A de C.V-ARKE SMO S.A. de C.V. ( Site 2210)

    Veracruz, 91910

    Study Coordinator, +522295896765

    Recruiting

Other trials in Mexico

New Zealand8 sites, 7 recruiting

  • Pacific Clinical Research Network West Auckland ( Site 2301)

    Auckland, 0600

    Study Coordinator, +6498830123

    Recruiting

  • Optimal Clinical Trials North ( Site 2308)

    Auckland, 0627

    Study Coordinator, +64800737327

    Recruiting

  • Silverdale Medical Limited ( Site 2305)

    Auckland, 0932

    Study Coordinator, +6494279997

    Recruiting

  • Optimal Clinical Trials ( Site 2306)

    Auckland, 1010

    Study Coordinator, +64800737327

    Recruiting

  • CGM Research Trust ( Site 2307)

    Christchurch, Canterbury, 8013

    Active, not recruiting

  • Lakeland Clinical Trials Waikato ( Site 2302)

    Nawton, Waikato Region, 3200

    Study Coordinator, +64273415595

    Recruiting

  • Pacific Clinical Research Network - Tasman ( Site 2304)

    Nelson, Tasman District, 7011

    Study Coordinator, +64211448740

    Recruiting

  • Lakeland Clinical Trials Wellington ( Site 2303)

    Upper Hutt, Wellington Region, 5018

    Study Coordinator, +6449201800

    Recruiting

Other trials in New Zealand

Colombia7 sites, 6 recruiting

  • IPS Centro Científico Asistencial S.A.S ( Site 0800)

    Barranquilla, Atlántico, 080020

    Study Coordinator, +576053485939

    Recruiting

  • Clinica Colsanitas - Sede Reina Sofia ( Site 0807)

    Bogotá, Bogota D.C., 110111

    Completed

  • Clinica Colsanitas S.A, Sede Clínica Universitaria Colombia ( Site 0804)

    Bogotá, Bogota D.C., 111321

    Study Coordinator, +576015948650

    Recruiting

  • Fundación Valle del Lili ( Site 0803)

    Cali, Valle del Cauca Department, 760032

    Study Coordinator, 57 602 3319090x4022

    Recruiting

  • IPS SURA San Diego ( Site 0806)

    Medellín, Antioquia, 50016

    Study Coordinator, +573183399032

    Recruiting

  • IMAT S.A.S ( Site 0805)

    Montería, Departamento de Córdoba, 230002

    Study Coordinator, 3135342052

    Recruiting

  • Sociedad De Oncología y Hematología Del Cesar SAS-Oncology ( Site 0801)

    Valledupar, Cesar Department, 200001

    Study Coordinator, 573015371818

    Recruiting

Other trials in Colombia

Romania7 sites, 6 recruiting

  • Spitalul Clinic De Urgenta Prof Dr Agrippa Ionescu ( Site 2705)

    Baloteşti, Ilfov, 077015

    Completed

  • Spitalul Clinic de Boli Infecțioase și Tropicale Victor Babeș ( Site 2701)

    Bucharest, Bucharest, 030303

    Study Coordinator, +40213172727

    Recruiting

  • Centrul Medical SANA ( Site 2704)

    Bucharest, 011025

    Study Coordinator, +40212128222

    Recruiting

  • National Institute for Infectious Diseases Prof. Dr. Matei Bals ( Site 2706)

    Bucharest, 021105

    Study Coordinator, +40212010980

    Recruiting

  • National Institute for Infectious Diseases Prof. Dr. Matei Bals ( Site 2707)

    Bucharest, 021105

    Study Coordinator, +40212010980

    Recruiting

  • Spitalul Clinic de Boli Infecțioase ( Site 2703)

    Cluj-Napoca, 400348

    Study Coordinator, +40264594655

    Recruiting

  • Spitalul Clinic de Boli Infecțioase ( Site 2702)

    Constanța, 900709

    Study Coordinator, +40771696527

    Recruiting

Other trials in Romania

Japan6 sites, 6 recruiting

  • National Hospital Organization Kyushu Medical Center ( Site 2006)

    Fukuoka, 810-8563

    Study Coordinator, +81-92-852-0700

    Recruiting

  • National Hospital Organization Tokyo National Hospital ( Site 2003)

    Kiyose, Tokyo, 204-8585

    Study Coordinator, +81-42-491-2111

    Recruiting

  • Kumamoto Chuo Hospital ( Site 2002)

    Kumamoto, 862-0965

    Study Coordinator, +81-96-370-3111

    Recruiting

  • Sekino Hospital ( Site 2016)

    Toshimaku, Tokyo, 171-0014

    Study Coordinator, +81-3-3986-5501

    Recruiting

  • Tsuchiura Beryl Clinic ( Site 2009)

    Tsuchiura, Ibaraki, 300-0062

    Study Coordinator, +81-29-835-3002

    Recruiting

  • National Hospital Organization Shimoshizu National Hospital ( Site 2007)

    Yotsukaidō, Chiba, 284-0003

    Study Coordinator, +81-43-422-2511

    Recruiting

Other trials in Japan

Brazil5 sites, 4 recruiting

  • Hospital Felicio Rocho (HFR) - Nucleo de Ciencias da Saude ( Site 0402)

    Belo Horizonte, Minas Gerais, 30180-080

    Completed

  • Centro de Pesquisa Sao Lucas ( Site 0401)

    Campinas, São Paulo, 13060-803

    Study Coordinator, +55 019997718356

    Recruiting

  • Instituto Atena de Pesquisa Clinica ( Site 0406)

    Natal, Rio Grande do Norte, 59020-500

    Study Coordinator, +558420203430

    Recruiting

  • Centro de Pesquisa em Medicina Tropical - CEPEM - Rondonia ( Site 0405)

    Porto Velho, Rondônia, 76812329

    Study Coordinator, +556932196012

    Recruiting

  • Centro de Pesquisa Clinica Institucional do HCFMUSP - CPCi ( Site 0403)

    São Paulo, 05403-010

    Study Coordinator, +55 11 2661-7214

    Recruiting

Other trials in Brazil

Argentina4 sites, 4 recruiting

  • CEMIC ( Site 0101)

    Buenos Aires., Buenos Aires, C1431FWO

    Study Coordinator, +54-911-36115955

    Recruiting

  • Hospital Italiano de Buenos Aires ( Site 0107)

    Ciudad Autonoma de Buenos Aires., Buenos Aires, C1199ABB

    Study Coordinator, +54-911-36115955

    Recruiting

  • Instituto de Investigaciones Clinicas Mar del Plata ( Site 0111)

    Mar del Plata, Buenos Aires, B7600FZO

    Study Coordinator, +542234963224

    Recruiting

  • Nefra Medical Care - Moron ( Site 0109)

    Morón, Buenos Aires, 1708

    Study Coordinator, +541146291083

    Recruiting

Other trials in Argentina

France4 sites, 3 recruiting

  • Centre Hospitalier Universitaire Dijon Bourgogne - Hôpital F-Centre d'Investigation Clinique - Plur ( Site 1301)

    Dijon, Bourgogne-Franche-Comté, 21000

    Study Coordinator, 3380295920

    Recruiting

  • Pitie Salpetriere University Hospital-Infectious Disease - Tropical Diseases ( Site 1300)

    Paris, Île-de-France Region, 75013

    Completed

  • centre hospitalier lyon sud ( Site 1303)

    Pierre-Bénite, Rhone, 69310

    Study Coordinator, +33771581547

    Recruiting

  • CHU de Saint-Etienne ( Site 1302)

    Saint Priest En Jarez, Pays de la Loire Region, 42270

    Study Coordinator, +33477120587

    Recruiting

Other trials in France

Germany4 sites, 2 recruiting

  • Campus Charite Mitte Nephrologie und Internistische Intensivmedizin ( Site 1501)

    Berlin, State of Berlin, 10117

    Completed

  • Universitaetsklinikum Koeln ( Site 1505)

    Cologne, North Rhine-Westphalia, 50937

    Study Coordinator, 004922147839680

    Recruiting

  • Universitätsklinikum Frankfurt Goethe-Universität ( Site 1503)

    Frankfurt am Main, Hesse, 60590

    Completed

  • TUM Klinikum ( Site 1502)

    Munich, Bavaria, 81675

    Study Coordinator, 00498941406323

    Recruiting

Other trials in Germany

Italy4 sites, 4 recruiting

  • IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola ( Site 1904)

    Bologna, 40138

    Study Coordinator, +390512143977

    Recruiting

  • Ospedale San Martino ( Site 1900)

    Genova, 16132

    Study Coordinator, +390105554667

    Recruiting

  • ASST Fatebenefratelli Sacco ( Site 1901)

    Milan, 20157

    Study Coordinator, +390239042676

    Recruiting

  • AOU Pisana- Ospedale Cisanello ( Site 1905)

    Pisa, 56124

    Study Coordinator, 39050955431

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Other trials in Italy

Philippines4 sites, 4 recruiting

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    Study Coordinator, 639338190062

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  • Ospital Ng Makati ( Site 2505)

    Makati City, National Capital Region, 1218

    Study Coordinator, +63288810983

    Recruiting

  • Philippine General Hospital-Department of Medicine ( Site 2504)

    Manila, National Capital Region, 1000

    Study Coordinator, (02) 8554 8400

    Recruiting

  • GreenCity Medical Center ( Site 2503)

    San Fernando City, Pampanga, 2000

    Study Coordinator, 639222385026

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Other trials in Philippines

Peru3 sites, 3 recruiting

  • Asociación Civil Selva Amazónica ( Site 2405)

    Iquitos, Loreto, 16001

    Study Coordinator, +51980463994

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  • Via Libre ( Site 2409)

    Lima, 15001

    Study Coordinator, +5112030099

    Recruiting

  • Clinica Ricardo Palma-Centro de Investigacion de Enfermedades Respiratorias Thorax ( Site 2404)

    Lima, 15036

    Study Coordinator, 012253445

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Puerto Rico3 sites, 3 recruiting

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    Study Coordinator, 787 656 0161

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    San Juan, 00921

    Study Coordinator, 787 226 1014

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  • MV HEALTH SERVICES LLC ( Site 4003)

    San Juan, 00926

    Study Coordinator, 787 365 2102

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Thailand2 sites

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    Active, not recruiting

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Finland1 site, 1 recruiting

  • MeVac - Meilahti Vaccine Research Center ( Site 1200)

    Helsinki, Uusimaa, 00290

    Study Coordinator, +358504270446

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Other trials in Finland

About this study

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

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.

Being tested
Molnupiravir, Placebo
Medical subject headings
COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MolnupiravirDrug

    Also called MK-4482, LAGEVRIO®

    Molnupiravir administered orally as two 400 mg film-coated tablets every 12 hours for 5 days (a total of 10 consecutive doses)

  • PlaceboDrug

    Molnupiravir-matching placebo administered orally as two film-coated tablets every 12 hours for 5 days (a total of 10 consecutive doses)

Study groups in NCT06667700
Study groupRoleWhat they receive
MolnupiravirExperimentalParticipants will receive 800 mg molnupiravir orally every 12 hours for 5 days (a total of 10 consecutive doses)
Receives: Drug: Molnupiravir
PlaceboPlacebo comparatorParticipants will receive molnupiravir-matching placebo orally every 12 hours for 5 days (a total of 10 consecutive doses)
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    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.

    Measured: Up to 29 days

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

    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.

    Measured: Up to approximately 5 months

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

    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.

    Measured: Up to approximately 5 days

Secondary outcomes (7)

  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

    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.

    Measured: Up to 29 days

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

    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.

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

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

    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.

    Measured: Up to 29 days

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

    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.

    Measured: Up to 29 days

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

    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.

    Measured: Up to 29 days

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

    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.

    Measured: Up to 29 days

  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

    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.

    Measured: Up to 29 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Oct 2024
  2. Study start2 Dec 2024
  3. Primary completion26 Jan 2031 (estimated)
  4. Study completion26 Jan 2031 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
3,082 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06667700
Sponsor's protocol ID
4482-023
Other IDs
2023-507227-36-00, U1111-1295-4678, MK-4482-023, jRCT2031250022, 2023
Acronym
MOVe-NOW
Status last verified
Oct 2026
First submitted
30 Oct 2024
Last updated
20 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Molnupiravir in people with Coronavirus Disease (COVID-19), run by Merck Sharp & Dohme LLC at 227 sites in 24 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 19 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 227 sites in United States, Ukraine, Bulgaria, Poland, South Korea and 19 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Toll Free Number (1-888-577-8839, Trialsites@msd.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06667700.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2026.

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