Efficacy and Safety of Molnupiravir (MK-4482) in Hospitalized Adult Participants With COVID-19 (MK-4482-001)

A Phase 2/3, Randomized, Placebo-Controlled, Double-Blind Clinical Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of MK-4482 in Hospitalized Adults With COVID-19

This study aims to evaluate the safety, tolerability and efficacy of molnupiravir (MK-4482) compared to placebo. The primary hypothesis is that molnupiravir is superior to placebo as assessed by the rate of sustained recovery through Day 29.

Study Overview

• Status: Terminated
• Conditions: Coronavirus Disease (COVID-19)
• Intervention / Treatment: Drug: Molnupiravir; Drug: Placebo

Detailed Description

This study was intended to include two parts: Part 1 was a dose-ranging phase 2 study, and Part 2 was a phase 3 study to evaluate the dose selected in Part 1. However, this study was terminated due to business reasons prior to conducting Part 2. Participants in Part 1 were followed until Month 7.

• Study Type: Interventional
• Enrollment (Actual): 304
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Brazil
  • Distrito Federal
    • Brasilia, Distrito Federal, Brazil, 72145-424
      • Chronos Pesquisa Clínica ( Site 0105)
  • Minas Gerais
    • Belo Horizonte, Minas Gerais, Brazil, 30150-221
      • Santa Casa de Misericordia de Belo Horizonte ( Site 0100)
  • Parana
    • Curitiba, Parana, Brazil, 80060-900
      • Hospital de Clinicas da Universidade Federal do Parana ( Site 0104)
  • Rio Grande Do Sul
    • Bento Goncalves, Rio Grande Do Sul, Brazil, 95700-000
      • Hospital Tacchini ( Site 0107)
  • Sao Paulo
    • Sao Jose do Rio Preto, Sao Paulo, Brazil, 15090-000
      • FUNFARME Hospital de Base Centro Integrado de Pesquisa ( Site 0101)
• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G 2N2
      • University Health Network - Toronto General Hospital ( Site 0201)
• Chile
  • Libertador General Bernardo O Higgins
    • Rancagua, Libertador General Bernardo O Higgins, Chile, 2820945
      • Hospital Clinico Fusat ( Site 0300)
  • Region M. De Santiago
    • Santiago, Region M. De Santiago, Chile, 2820945
      • Clinica Universidad de los Andes ( Site 0301)
    • Santiago, Region M. De Santiago, Chile, 8207257
      • Hospital Sotero del Rio [Santiago, Chile] ( Site 0304)
    • Santiago, Region M. De Santiago, Chile, 8380419
      • Complejo Hospitalario San Jose ( Site 0306)
    • Santiago, Region M. De Santiago, Chile, 8900085
      • Servicio de Salud Sur Hospital Lucio Cordova ( Site 0305)
• Colombia
  • Antioquia
    • Medellin, Antioquia, Colombia, 050034
      • Hospital Pablo Tobon Uribe ( Site 0404)
  • Atlantico
    • Barranquilla, Atlantico, Colombia, 080020
      • Clinica de la Costa Ltda. ( Site 0402)
  • Cordoba
    • Monteria, Cordoba, Colombia, 230002
      • Oncomedica S.A. ( Site 0406)
  • Distrito Capital De Bogota
    • Bogota, Distrito Capital De Bogota, Colombia, 110231
      • Hospital Universitario San Ignacio ( Site 0401)
  • Santander
    • Bucaramanca, Santander, Colombia, 680003
      • Fundacion Cardiovascular de Colombia ( Site 0403)
  • Valle Del Cauca
    • Cali, Valle Del Cauca, Colombia, 760032
      • Fundacion Valle del Lili ( Site 0400)
• France
  • Paris, France, 75012
    • CHU Hopital Saint Antoine ( Site 0505)
  • Paris, France, 75018
    • Hopital Bichat - Claude Bernard ( Site 0503)
  • Gironde
    • Bordeaux, Gironde, France, 33000
      • Groupe Hospitalier Pellegrin ( Site 0511)
  • Ile-de-France
    • Paris, Ile-de-France, France, 75013
      • Pitie Salpetriere University Hospital-Infectious Disease - Tropical Diseases ( Site 0504)
  • Midi-Pyrenees
    • Toulouse, Midi-Pyrenees, France, 31059
      • C.H.U. de Toulouse. Hopital de Purpan ( Site 0501)
  • Nord
    • Tourcoing, Nord, France, 59208
      • Centre Hospitalier de Tourcoing ( Site 0502)
• Israel
  • Haifa, Israel, 3525408
    • Rambam Medical Center ( Site 2102)
  • Jerusalem, Israel, 9112001
    • Hadassah Medical Center. Ein Kerem ( Site 2103)
  • Ramat Gan, Israel, 5265601
    • Chaim Sheba Medical Center ( Site 2100)
• Italy
  • Milano, Italy, 20157
    • ASST Fatebenefratelli-Ospedale Sacco ( Site 0601)
• Korea, Republic of
  • Incheon, Korea, Republic of, 22332
    • Inha University Hospital ( Site 2204)
  • Seoul, Korea, Republic of, 03312
    • The Catholic University of Korea Eunpyeong St Mary s Hospital ( Site 2205)
  • Taejon-Kwangyokshi
    • Daejeon, Taejon-Kwangyokshi, Korea, Republic of, 30515
      • Chungnam National University Hospital ( Site 2202)
• Mexico
  • Distrito Federal
    • Ciudad de mexico, Distrito Federal, Mexico, 14080
      • Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran ( Site 0802)
  • Guanajuato
    • Leon, Guanajuato, Mexico, 37660
      • Hospital Regional de Alta Especialidad del Bajio ( Site 0807)
  • Jalisco
    • Guadalajara, Jalisco, Mexico, 44280
      • Hospital Civil de Guadalajara Fray Antonio Alcalde ( Site 0800)
  • Nuevo Leon
    • Monterrey, Nuevo Leon, Mexico, 64460
      • Hospital Universitario Dr. Jose Eleuterio Gonzalez ( Site 0803)
• Philippines
  • National Capital Region
    • Manila, National Capital Region, Philippines, 1000
      • University of the Philippines-Philippine General Hospital ( Site 0900)
    • Quezon City, National Capital Region, Philippines, 1100
      • Lung Center of the Philippines ( Site 0902)
• Poland
  • Lodzkie
    • Lodz-Baluty, Lodzkie, Poland, 91-347
      • Wojewodzki Szpital Specjalistyczny im. dr. Wladyslawa Bieganskiego ( Site 1001)
  • Lubelskie
    • Lublin, Lubelskie, Poland, 20-081
      • Samodzielny Publiczny Szpital Kliniczny Nr 1 w Lublinie ( Site 1004)
  • Mazowieckie
    • Ostroleka, Mazowieckie, Poland, 07-410
      • Centrum Medyczne Pratia, Mazowiecki Szpital Specjalistyczny, Oddział Obserwacyjno - Zakaźny ( Site 1
  • Podkarpackie
    • Lancut, Podkarpackie, Poland, 37-100
      • Centrum Medyczne w Lancucie Sp.zo.o. ( Site 1000)
• Russian Federation
  • Moskovskaya Oblast
    • Krasnogorsk, Moskovskaya Oblast, Russian Federation, 143408
      • Krasnogorsk City Hospital Number 1 ( Site 1119)
  • Moskva
    • Moscow, Moskva, Russian Federation, 108814
      • City Clinical Hospital #40 ( Site 1109)
    • Moscow, Moskva, Russian Federation, 121359
      • FSBI Central Hospital with Policlinics ( Site 1105)
    • Moscow, Moskva, Russian Federation, 123182
      • Moscow Clinical Hospital #52 ( Site 1103)
  • Sankt-Peterburg
    • Saint Petersburg, Sankt-Peterburg, Russian Federation, 197706
      • City Hospital #40 ( Site 1113)
    • Saint-Petersburg, Sankt-Peterburg, Russian Federation, 199106
      • City Pokrovskaya hospital ( Site 1116)
  • Smolenskaya Oblast
    • Smolensk, Smolenskaya Oblast, Russian Federation, 214006
      • City Clinical Hospital #1 ( Site 1112)
  • Tatarstan, Respublika
    • Kazan, Tatarstan, Respublika, Russian Federation, 420140
      • Republican Clinical Infectious Hospital n.a. A.F. Agafonov ( Site 1100)
• South Africa
  • Free State
    • Bloemfontein, Free State, South Africa, 9301
      • IATROS International ( Site 1202)
  • Gauteng
    • Soweto, Gauteng, South Africa, 2013
      • Wits Baragwanath Clinical Trial Site ( Site 1204)
  • Western Cape
    • Cape Town, Western Cape, South Africa, 7500
      • TREAD Research ( Site 1201)
    • Worcester, Western Cape, South Africa, 6850
      • Clinical Projects Research Centre ( Site 1205)
• Spain
  • Barcelona, Spain, 08036
    • Hospital Clinic ( Site 1304)
  • Barcelona, Spain, 08916
    • Hospital Universitari Germans Trias i Pujol ( Site 1303)
  • Madrid, Spain, 28007
    • Hospital Universitario Gregorio Maranon ( Site 1302)
  • Madrid, Spain, 28034
    • Hospital Universitario Ramon y Cajal ( Site 1301)
  • Madrid, Spain, 28046
    • Hospital Universitario La Paz ( Site 1300)
  • Cataluna
    • Barcelona, Cataluna, Spain, 08035
      • Hospital Universitari Vall d Hebron ( Site 1305)
• Ukraine
  • Ivano-Frankivska Oblast
    • Ivano-Frankivsk, Ivano-Frankivska Oblast, Ukraine, 76007
      • Ivano-Frankivsk Regional Clinical Infectious Diseases Hospital ( Site 1605)
    • Ivano-Frankivsk, Ivano-Frankivska Oblast, Ukraine, 76018
      • CNE Central city clinical hospital of Ivano-Frankivsk city council ( Site 1604)
    • Ivano-Frankivsk, Ivano-Frankivska Oblast, Ukraine, 76018
      • MNE Ivano-Frankivsk Regional Phthisiology-Pulmonology Center ( Site 1603)
  • Kharkivska Oblast
    • Kharkiv, Kharkivska Oblast, Ukraine, 61000
      • CNPE of Kharkiv RC Regional Clinical Infectious Diseases Hospital ( Site 1606)
  • Kyivska Oblast
    • Kyiv, Kyivska Oblast, Ukraine, 01601
      • Сommunal non-com. Institution Oleksandrivska clinical hospital Kyiv ( Site 1600)
  • Odeska Oblast
    • Odesa, Odeska Oblast, Ukraine, 65023
      • Odesa City Clinical Infectious Hospital ( Site 1611)
  • Rivnenska Oblast
    • Rivne, Rivnenska Oblast, Ukraine, 33018
      • Communal Non-Commercial Enterprise Central City Hospital ( Site 1615)
  • Volynska Oblast
    • Lutsk, Volynska Oblast, Ukraine, 43005
      • Volyn Regional Clinical Hospital ( Site 1613)
• United Kingdom
  • Manchester, United Kingdom, M8 5RB
    • North Manchester General Hospital ( Site 1701)
  • London, City Of
    • London, London, City Of, United Kingdom, NW3 2QG
      • Royal Free London NHS Foundation Trust ( Site 1700)
    • London, London, City Of, United Kingdom, SE5 9RS
      • King's College Hospital ( Site 1705)
• United States
  • California
    • Harbor City, California, United States, 90710
      • Kaiser Foundation Hospital - South Bay ( Site 1832)
    • Los Angeles, California, United States, 90048
      • Cedars-Sinai Medical Center ( Site 1822)
    • Sacramento, California, United States, 95817
      • University of California Davis Health ( Site 1809)
  • Florida
    • Gainesville, Florida, United States, 32610
      • University Of Florida ( Site 1810)
  • Georgia
    • Marietta, Georgia, United States, 30060
      • Wellstar Kennestone Hospital ( Site 1801)
  • Illinois
    • Chicago, Illinois, United States, 60644
      • Loretto Hospital ( Site 1838)
  • Louisiana
    • Shreveport, Louisiana, United States, 71103
      • LSU-HSC Shreveport ( Site 1824)
  • Michigan
    • Detroit, Michigan, United States, 48202-2608
      • Henry Ford Health System ( Site 1821)
  • Mississippi
    • Jackson, Mississippi, United States, 39216
      • University of Mississippi Medical Center ( Site 1846)
  • Nebraska
    • Omaha, Nebraska, United States, 68198
      • University of Nebraska Medical Center ( Site 1835)
  • New Mexico
    • Albuquerque, New Mexico, United States, 87131
      • University of New Mexico, Health Sciences Center ( Site 1806)
  • North Carolina
    • Charlotte, North Carolina, United States, 28203
      • Carolinas Medical Center ( Site 1850)
    • Greenville, North Carolina, United States, 27834
      • ECU Adult Specialty Care ( Site 1865)
  • North Dakota
    • Fargo, North Dakota, United States, 58122
      • Sanford Health ( Site 1851)
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19140
      • Temple University ( Site 1836)
  • Texas
    • Corpus Christi, Texas, United States, 78404
      • CHRISTUS Institute for Innovation & Advanced Clinical Care ( Site 1864)
    • Houston, Texas, United States, 77030
      • Houston Methodist Hospital ( Site 1863)
  • Washington
    • Edmonds, Washington, United States, 98026
      • Swedish Medical Center ( Site 1812)
    • Renton, Washington, United States, 98055
      • Valley Medical Center ( Site 1815)
    • Seattle, Washington, United States, 98122
      • Swedish Medical Center ( Site 1861)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Has documentation of polymerase chain reaction (PCR)-confirmed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection with sample collection ≤ 10 days prior to the day of randomization. PCR is the preferred method; however other diagnostic methods are allowed if authorized by use in the country
• Had initial onset of signs/symptoms attributable to COVID-19 for ≤10 days prior to the day of randomization and ≥1 sign/symptom attributable to COVID-19 present at randomization
• Requires medical care in the hospital for ongoing clinical manifestations of COVID-19 (not just for public health or quarantine purposes)
• Has mild, moderate, or severe COVID-19
• Is willing and able to take oral medication
• Males agree to the following during the intervention period and for at least 90 days after the last dose of study intervention: Refrain from donating sperm; and either abstain from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent; or must agree to use contraception
• Females are not pregnant or breastfeeding, and at least one of the following conditions applies: Is not a woman of child bearing potential (WOCBP); or is a WOCBP and using a contraceptive method that is highly effective (a low user dependency method OR a user dependent method in combination with barrier method), or be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis) for 28 days from the start of study intervention; a WOCBP must have a negative highly sensitive pregnancy test (serum test is required) within 24 hours before the first dose of study intervention

Exclusion Criteria:

• Has critical COVID-19 with any of the following: respiratory failure (including endotracheal intubation and mechanical ventilation, oxygen delivered by high-flow nasal cannula (flow rates >20L/min with fraction of delivered oxygen ≥ 0.5), noninvasive positive pressure ventilation, or extracorporeal membrane oxygenation (ECMO))
• Is on dialysis or has reduced estimated glomerular filtration rate (eGFR) <30 mL/min/1.73m^2 by the Modification of Diet in Renal Disease (MDRD) equation
• Has any of the following conditions: human immunodeficiency virus (HIV) with a recent viral load >50 copies/mL or cluster of differentiation 4 (CD4) <200 cell/mm^3; chemotherapy required within 6 weeks before randomization; a neutrophilic granulocyte absolute count <500/mm^3; autologous or allogeneic hematopoietic stem cell transplant recipient
• Has history of Hepatitis B or Hepatitis C infection with any of the following: 1) cirrhosis 2) end-stage liver disease 3) hepatocellular carcinoma 4) aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) > 3 times the upper limit of normal at screening
• Has a history of acute pancreatitis within 3 months prior to randomization or a history of chronic pancreatitis
• Is taking or is anticipated to require any prohibited therapies
• Is unwilling to abstain from participating in another interventional clinical trial through Day 29 with an investigational compound or device, including those for COVID-19 therapeutics
• Is anticipated to require transfer to a non-study hospital within 72 hours
• Has a baseline heart rate of < 50 beats per minute at rest
• Has a platelet count <100,000/μL or received a platelet transfusion in the 5 days prior to randomization
• Has hypersensitivity or other contraindication to any of the components of the study interventions as determined by the investigator
• Has any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant or that could prevent, limit, or confound the protocol-specified assessments including but not limited to: participants who are not expected to survive longer than 48 hours after randomization or participants who are expected to require mechanical ventilation within 48 hours after randomization or participants with a recent history of mechanical ventilation or participants with conditions that could limit gastrointestinal absorption of capsule contents

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part 1: Molnupiravir 200 mg; 200 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Drug: Molnupiravir; Molnupiravir administered orally in capsule form every 12 hours for 5 days (10 doses total)
Experimental: Part 1: Molnupiravir 400 mg; 400 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Drug: Molnupiravir; Molnupiravir administered orally in capsule form every 12 hours for 5 days (10 doses total)
Experimental: Part 1: Molnupiravir 800 mg; 800 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Drug: Molnupiravir; Molnupiravir administered orally in capsule form every 12 hours for 5 days (10 doses total)
Placebo Comparator: Part 1: Placebo; Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Drug: Placebo; Placebo matching molnupiravir administered orally in capsule form every 12 hours for 5 days (10 doses total)
Experimental: Part 2: Molnupiravir; Molnupiravir (dose to be selected) administered orally every 12 hours for 5 days (10 doses total)	Drug: Molnupiravir; Molnupiravir administered orally in capsule form every 12 hours for 5 days (10 doses total)
Placebo Comparator: Part 2: Placebo; Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Drug: Placebo; Placebo matching molnupiravir administered orally in capsule form every 12 hours for 5 days (10 doses total)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time-to-sustained Recovery	The median time to sustained recovery is reported. Sustained recovery is defined as 1) the participant is alive and not hospitalized; or 2) the participant is alive and medically ready for discharge as determined by the investigator.	Up to 29 days
Number of Participants With an Adverse Event (AE)	The number of participants with at least 1 AE is presented. 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.	Up to 19 days (during treatment and 14-day follow-up)
Number of Participants Who Discontinued Study Intervention Due to an AE	The number of participants discontinuing from study treatment due to an AE is presented. 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.	Up to 5 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With All-cause Mortality	The number of participants with all-cause mortality through Day 29 is presented. All-cause mortality is defined as death due to any cause. Any participants with an unknown survival status at Day 29 were imputed as deceased.	Up to 29 days
Odds of a More Favorable Response on Pulmonary Ordinal Outcome Score on Day 3	Pulmonary score is a score on an ordinal scale which focuses on respiratory sequalae based on oxygen requirements using 7 mutually exclusive categories. The score ranges from 1 ("can independently undertake personal usual activities with minimal or no symptoms") to 7 ("death") with a higher score indicating more severe respiratory sequalae. The number of participants at each score category is presented.	Day 3
Odds of a More Favorable Response on Pulmonary Ordinal Outcome Score on End of Treatment (EOT [Day 5])	Pulmonary score is a score on an ordinal scale which focuses on respiratory sequalae based on oxygen requirements using 7 mutually exclusive categories. The score ranges from 1 ("can independently undertake personal usual activities with minimal or no symptoms") to 7 ("death") with a higher score indicating more severe respiratory sequalae. The number of participants at each score category is presented.	EOT (Day 5)
Odds of a More Favorable Response on Pulmonary Ordinal Outcome Score on Day 10	Pulmonary score is a score on an ordinal scale which focuses on respiratory sequalae based on oxygen requirements using 7 mutually exclusive categories. The score ranges from 1 ("can independently undertake personal usual activities with minimal or no symptoms") to 7 ("death") with a higher score indicating more severe respiratory sequalae. The number of participants at each score category is presented.	Day 10
Odds of a More Favorable Response on Pulmonary Ordinal Outcome Score on Day 15	Pulmonary score is a score on an ordinal scale which focuses on respiratory sequalae based on oxygen requirements using 7 mutually exclusive categories. The score ranges from 1 ("can independently undertake personal usual activities with minimal or no symptoms") to 7 ("death") with a higher score indicating more severe respiratory sequalae. The number of participants at each score category is presented.	Day 15
Odds of a More Favorable Response on Pulmonary Ordinal Outcome Score on Day 29	Pulmonary score is a score on an ordinal scale which focuses on respiratory sequalae based on oxygen requirements using 7 mutually exclusive categories. The score ranges from 1 ("can independently undertake personal usual activities with minimal or no symptoms") to 7 ("death") with a higher score indicating more severe respiratory sequalae. The number of participants at each score category is presented.	Day 29
Odds of a More Favorable Response on Pulmonary+ Ordinal Outcome Score on Day 3	Pulmonary+ score is a score on an ordinal scale which is a 7-category assessment that captures the range of disease severity in hospitalized participants, including coagulation-related complications and respiratory dysfunction. The score ranges from 1 ("can independently undertake personal usual activities with minimal or no symptoms") to 7 ("death") with a higher score indicating more severe respiratory sequalae. The number of participants at each score category is presented.	Day 3
Odds of a More Favorable Response on Pulmonary+ Ordinal Outcome Score on EOT (Day 5)	Pulmonary+ score is a score on an ordinal scale which is a 7-category assessment that captures the range of disease severity in hospitalized participants, including coagulation-related complications and respiratory dysfunction. The score ranges from 1 ("can independently undertake personal usual activities with minimal or no symptoms") to 7 ("death") with a higher score indicating more severe respiratory sequalae. The number of participants at each score category is presented.	EOT (Day 5)
Odds of a More Favorable Response on Pulmonary+ Ordinal Outcome Score on Day 10	Pulmonary+ score is a score on an ordinal scale which is a 7-category assessment that captures the range of disease severity in hospitalized participants, including coagulation-related complications and respiratory dysfunction. The score ranges from 1 ("can independently undertake personal usual activities with minimal or no symptoms") to 7 ("death") with a higher score indicating more severe respiratory sequalae. The number of participants at each score category is presented.	Day 10
Odds of a More Favorable Response on Pulmonary+ Ordinal Outcome Score on Day 15	Pulmonary+ score is a score on an ordinal scale which is a 7-category assessment that captures the range of disease severity in hospitalized participants, including coagulation-related complications and respiratory dysfunction. The score ranges from 1 ("can independently undertake personal usual activities with minimal or no symptoms") to 7 ("death") with a higher score indicating more severe respiratory sequalae. The number of participants at each score category is presented.	Day 15
Odds of a More Favorable Response on Pulmonary+ Ordinal Outcome Score on Day 29	Pulmonary+ score is a score on an ordinal scale which is a 7-category assessment that captures the range of disease severity in hospitalized participants, including coagulation-related complications and respiratory dysfunction. The score ranges from 1 ("can independently undertake personal usual activities with minimal or no symptoms") to 7 ("death") with a higher score indicating more severe respiratory sequalae. The number of participants at each score category is presented.	Day 29
Odds of a More Favorable Response in the Clinical Risk of Mortality Category From the National Early Warning Score	The National Early Warning Score (Royal College of Physicians, 2012) assesses a participant's degree of illness as assessed by clinical risk prediction categories based on a set of vital sign measurements. There are 7 physiological parameters: respiration rate, oxygen saturation, supplemental oxygen, systolic blood pressure, pulse rate, level of consciousness, and temperature. A score of 0 to 3 was allocated to each parameter except supplemental oxygen use (score of 0 [no] or 2 [yes]) and level of consciousness (score of 0 or 3 with 0 = normal health condition and 3 = worst health condition). All scores were summed to get an aggregate score. Aggregate NEWS score ranged from 0 to 19, with higher scores meaning more severity/higher risk: low risk (score 0 to 4); low to medium risk (score of 3 in any individual parameter); medium risk (score 5 to 6); high risk (score 7 to 19). The number of participants at each aggregate risk category is presented.	EOT (Day 5)
Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 3	The World Health Organization (WHO) outcome scale is an 11-point ordinal score that categorizes clinical progression. Score ranges from 0 ("uninfected") to 10 ("dead") with higher score indicating clinical progression. The number of participants at each score category is presented.	Day 3
Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on EOT (Day 5)	The World Health Organization (WHO) outcome scale is an 11-point ordinal score that categorizes clinical progression. Score ranges from 0 ("uninfected") to 10 ("dead") with higher score indicating clinical progression. The number of participants at each score category is presented.	EOT (Day 5)
Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 10	The World Health Organization (WHO) outcome scale is an 11-point ordinal score that categorizes clinical progression. Score ranges from 0 ("uninfected") to 10 ("dead") with higher score indicating clinical progression. The number of participants at each score category is presented.	Day 10
Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 15	The World Health Organization (WHO) outcome scale is an 11-point ordinal score that categorizes clinical progression. Score ranges from 0 ("uninfected") to 10 ("dead") with higher score indicating clinical progression. The number of participants at each score category is presented.	Day 15
Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 29	The World Health Organization (WHO) outcome scale is an 11-point ordinal score that categorizes clinical progression. Score ranges from 0 ("uninfected") to 10 ("dead") with higher score indicating clinical progression. The number of participants at each score category is presented.	Day 29

Collaborators and Investigators

• Sponsor: Merck Sharp & Dohme LLC

Publications and helpful links

General Publications

• Arribas JR, Bhagani S, Lobo SM, Khaertynova I, Mateu L, Fishchuk R, Park WY, Hussein K, Kim SW, Ghosn J, Brown ML, Zhang Y, Gao W, Assaid C, Grobler JA, Strizki J, Vesnesky M, Paschke A, Butterton JR, De Anda C, for the MOVe-IN study group. Randomized Trial of Molnupiravir or Placebo in Patients Hospitalized with Covid-19. NEJM Evid 2021; 1 (2) DOI: 10.1056/EVIDoa2100044. Published December 16, 2021. https://evidence.nejm.org/doi/full/10.1056/EVIDoa2100044

Study record dates

Study Major Dates

• Study Start (Actual): October 19, 2020
• Primary Completion (Actual): August 11, 2021
• Study Completion (Actual): August 11, 2021

Study Registration Dates

• First Submitted: September 30, 2020
• First Submitted That Met QC Criteria: October 2, 2020
• First Posted (Actual): October 5, 2020

Study Record Updates

• Last Update Posted (Estimate): January 16, 2023
• Last Update Submitted That Met QC Criteria: January 13, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: 4482-001; MK-4482-001 (Other Identifier: Merck); PHRR201210-003189 (Registry Identifier: PHRR); jRCT2031200404 (Registry Identifier: jRCT); 2020-003367-26 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No