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

Primary Purpose

Coronavirus Disease (COVID-19)

Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Molnupiravir
Placebo
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronavirus Disease (COVID-19)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Kaiser Foundation Hospital - South Bay ( Site 1832)
  • Cedars-Sinai Medical Center ( Site 1822)
  • University of California Davis Health ( Site 1809)
  • University Of Florida ( Site 1810)
  • Wellstar Kennestone Hospital ( Site 1801)
  • Loretto Hospital ( Site 1838)
  • LSU-HSC Shreveport ( Site 1824)
  • Henry Ford Health System ( Site 1821)
  • University of Mississippi Medical Center ( Site 1846)
  • University of Nebraska Medical Center ( Site 1835)
  • University of New Mexico, Health Sciences Center ( Site 1806)
  • Carolinas Medical Center ( Site 1850)
  • ECU Adult Specialty Care ( Site 1865)
  • Sanford Health ( Site 1851)
  • Temple University ( Site 1836)
  • CHRISTUS Institute for Innovation & Advanced Clinical Care ( Site 1864)
  • Houston Methodist Hospital ( Site 1863)
  • Swedish Medical Center ( Site 1812)
  • Valley Medical Center ( Site 1815)
  • Swedish Medical Center ( Site 1861)
  • Chronos Pesquisa Clínica ( Site 0105)
  • Santa Casa de Misericordia de Belo Horizonte ( Site 0100)
  • Hospital de Clinicas da Universidade Federal do Parana ( Site 0104)
  • Hospital Tacchini ( Site 0107)
  • FUNFARME Hospital de Base Centro Integrado de Pesquisa ( Site 0101)
  • University Health Network - Toronto General Hospital ( Site 0201)
  • Hospital Clinico Fusat ( Site 0300)
  • Clinica Universidad de los Andes ( Site 0301)
  • Hospital Sotero del Rio [Santiago, Chile] ( Site 0304)
  • Complejo Hospitalario San Jose ( Site 0306)
  • Servicio de Salud Sur Hospital Lucio Cordova ( Site 0305)
  • Hospital Pablo Tobon Uribe ( Site 0404)
  • Clinica de la Costa Ltda. ( Site 0402)
  • Oncomedica S.A. ( Site 0406)
  • Hospital Universitario San Ignacio ( Site 0401)
  • Fundacion Cardiovascular de Colombia ( Site 0403)
  • Fundacion Valle del Lili ( Site 0400)
  • Groupe Hospitalier Pellegrin ( Site 0511)
  • Pitie Salpetriere University Hospital-Infectious Disease - Tropical Diseases ( Site 0504)
  • C.H.U. de Toulouse. Hopital de Purpan ( Site 0501)
  • Centre Hospitalier de Tourcoing ( Site 0502)
  • CHU Hopital Saint Antoine ( Site 0505)
  • Hopital Bichat - Claude Bernard ( Site 0503)
  • Rambam Medical Center ( Site 2102)
  • Hadassah Medical Center. Ein Kerem ( Site 2103)
  • Chaim Sheba Medical Center ( Site 2100)
  • ASST Fatebenefratelli-Ospedale Sacco ( Site 0601)
  • Chungnam National University Hospital ( Site 2202)
  • Inha University Hospital ( Site 2204)
  • The Catholic University of Korea Eunpyeong St Mary s Hospital ( Site 2205)
  • Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran ( Site 0802)
  • Hospital Regional de Alta Especialidad del Bajio ( Site 0807)
  • Hospital Civil de Guadalajara Fray Antonio Alcalde ( Site 0800)
  • Hospital Universitario Dr. Jose Eleuterio Gonzalez ( Site 0803)
  • University of the Philippines-Philippine General Hospital ( Site 0900)
  • Lung Center of the Philippines ( Site 0902)
  • Wojewodzki Szpital Specjalistyczny im. dr. Wladyslawa Bieganskiego ( Site 1001)
  • Samodzielny Publiczny Szpital Kliniczny Nr 1 w Lublinie ( Site 1004)
  • Centrum Medyczne Pratia, Mazowiecki Szpital Specjalistyczny, Oddział Obserwacyjno - Zakaźny ( Site 1
  • Centrum Medyczne w Lancucie Sp.zo.o. ( Site 1000)
  • Krasnogorsk City Hospital Number 1 ( Site 1119)
  • City Clinical Hospital #40 ( Site 1109)
  • FSBI Central Hospital with Policlinics ( Site 1105)
  • Moscow Clinical Hospital #52 ( Site 1103)
  • City Hospital #40 ( Site 1113)
  • City Pokrovskaya hospital ( Site 1116)
  • City Clinical Hospital #1 ( Site 1112)
  • Republican Clinical Infectious Hospital n.a. A.F. Agafonov ( Site 1100)
  • IATROS International ( Site 1202)
  • Wits Baragwanath Clinical Trial Site ( Site 1204)
  • TREAD Research ( Site 1201)
  • Clinical Projects Research Centre ( Site 1205)
  • Hospital Universitari Vall d Hebron ( Site 1305)
  • Hospital Clinic ( Site 1304)
  • Hospital Universitari Germans Trias i Pujol ( Site 1303)
  • Hospital Universitario Gregorio Maranon ( Site 1302)
  • Hospital Universitario Ramon y Cajal ( Site 1301)
  • Hospital Universitario La Paz ( Site 1300)
  • Ivano-Frankivsk Regional Clinical Infectious Diseases Hospital ( Site 1605)
  • CNE Central city clinical hospital of Ivano-Frankivsk city council ( Site 1604)
  • MNE Ivano-Frankivsk Regional Phthisiology-Pulmonology Center ( Site 1603)
  • CNPE of Kharkiv RC Regional Clinical Infectious Diseases Hospital ( Site 1606)
  • Сommunal non-com. Institution Oleksandrivska clinical hospital Kyiv ( Site 1600)
  • Odesa City Clinical Infectious Hospital ( Site 1611)
  • Communal Non-Commercial Enterprise Central City Hospital ( Site 1615)
  • Volyn Regional Clinical Hospital ( Site 1613)
  • Royal Free London NHS Foundation Trust ( Site 1700)
  • King's College Hospital ( Site 1705)
  • North Manchester General Hospital ( Site 1701)

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Arm Label

Part 1: Molnupiravir 200 mg

Part 1: Molnupiravir 400 mg

Part 1: Molnupiravir 800 mg

Part 1: Placebo

Part 2: Molnupiravir

Part 2: Placebo

Arm Description

200 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)

400 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)

800 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)

Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total)

Molnupiravir (dose to be selected) administered orally every 12 hours for 5 days (10 doses total)

Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total)

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
September 30, 2020
Last Updated
January 13, 2023
Sponsor
Merck Sharp & Dohme LLC
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1. Study Identification

Unique Protocol Identification Number
NCT04575584
Brief Title
Efficacy and Safety of Molnupiravir (MK-4482) in Hospitalized Adult Participants With COVID-19 (MK-4482-001)
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Terminated
Why Stopped
Business reasons
Study Start Date
October 19, 2020 (Actual)
Primary Completion Date
August 11, 2021 (Actual)
Study Completion Date
August 11, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronavirus Disease (COVID-19)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
304 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Part 1: Molnupiravir 200 mg
Arm Type
Experimental
Arm Description
200 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)
Arm Title
Part 1: Molnupiravir 400 mg
Arm Type
Experimental
Arm Description
400 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)
Arm Title
Part 1: Molnupiravir 800 mg
Arm Type
Experimental
Arm Description
800 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)
Arm Title
Part 1: Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total)
Arm Title
Part 2: Molnupiravir
Arm Type
Experimental
Arm Description
Molnupiravir (dose to be selected) administered orally every 12 hours for 5 days (10 doses total)
Arm Title
Part 2: Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total)
Intervention Type
Drug
Intervention Name(s)
Molnupiravir
Intervention Description
Molnupiravir administered orally in capsule form every 12 hours for 5 days (10 doses total)
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo matching molnupiravir administered orally in capsule form every 12 hours for 5 days (10 doses total)
Primary Outcome Measure Information:
Title
Time-to-sustained Recovery
Description
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.
Time Frame
Up to 29 days
Title
Number of Participants With an Adverse Event (AE)
Description
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.
Time Frame
Up to 19 days (during treatment and 14-day follow-up)
Title
Number of Participants Who Discontinued Study Intervention Due to an AE
Description
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.
Time Frame
Up to 5 days
Secondary Outcome Measure Information:
Title
Number of Participants With All-cause Mortality
Description
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.
Time Frame
Up to 29 days
Title
Odds of a More Favorable Response on Pulmonary Ordinal Outcome Score on Day 3
Description
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.
Time Frame
Day 3
Title
Odds of a More Favorable Response on Pulmonary Ordinal Outcome Score on End of Treatment (EOT [Day 5])
Description
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.
Time Frame
EOT (Day 5)
Title
Odds of a More Favorable Response on Pulmonary Ordinal Outcome Score on Day 10
Description
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.
Time Frame
Day 10
Title
Odds of a More Favorable Response on Pulmonary Ordinal Outcome Score on Day 15
Description
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.
Time Frame
Day 15
Title
Odds of a More Favorable Response on Pulmonary Ordinal Outcome Score on Day 29
Description
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.
Time Frame
Day 29
Title
Odds of a More Favorable Response on Pulmonary+ Ordinal Outcome Score on Day 3
Description
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.
Time Frame
Day 3
Title
Odds of a More Favorable Response on Pulmonary+ Ordinal Outcome Score on EOT (Day 5)
Description
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.
Time Frame
EOT (Day 5)
Title
Odds of a More Favorable Response on Pulmonary+ Ordinal Outcome Score on Day 10
Description
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.
Time Frame
Day 10
Title
Odds of a More Favorable Response on Pulmonary+ Ordinal Outcome Score on Day 15
Description
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.
Time Frame
Day 15
Title
Odds of a More Favorable Response on Pulmonary+ Ordinal Outcome Score on Day 29
Description
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.
Time Frame
Day 29
Title
Odds of a More Favorable Response in the Clinical Risk of Mortality Category From the National Early Warning Score
Description
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.
Time Frame
EOT (Day 5)
Title
Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 3
Description
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.
Time Frame
Day 3
Title
Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on EOT (Day 5)
Description
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.
Time Frame
EOT (Day 5)
Title
Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 10
Description
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.
Time Frame
Day 10
Title
Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 15
Description
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.
Time Frame
Day 15
Title
Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 29
Description
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.
Time Frame
Day 29

10. Eligibility

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

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
IPD Sharing URL
http://engagezone.msd.com/ds_documentation.php
Citations:
Citation
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
Results Reference
result

Learn more about this trial

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

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