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Efficacy and Safety of Molnupiravir (MK-4482) in Non-Hospitalized Adult Participants With COVID-19 (MK-4482-002)

Primary Purpose

Coronavirus Disease (COVID-19)

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

Molnupiravir

Placebo

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 laboratory confirmed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection with sample collection ≤5 days prior to the day of randomization. PCR is the preferred method; however with evolving approaches to laboratory confirmation of SARS-CoV-2 infection, other molecular or antigen tests that detect viral ribonucleic acid (RNA) or protein are allowed if authorized for use in the country. Serological tests that detect host antibodies generated in response to recent or prior infection are not allowed.
Had initial onset of signs/symptoms attributable to COVID-19 for ≤5 days prior to the day of randomization and at least 1 of the following sign/symptom attributable to COVID-19 on the day of randomization.
Has mild or moderate COVID-19.
Has at least 1 characteristic or underlying medical condition associated with an increased risk of severe illness from COVID-19.
Males agree to the following during the intervention period and for at least 4 days after the last dose of study intervention: 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 at least 4 days after the last dose of study intervention; a WOCBP must have a negative highly sensitive pregnancy test (urine or serum test is required) within 24 hours before the first dose of study intervention.

Exclusion Criteria:

Is currently hospitalized or is expected to need hospitalization for COVID-19 within 48 hours of randomization.
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 (regardless of CD4 count) or an AIDS-defining illness in the past 6 months, participants with HIV may only be enrolled if on a stable antiretroviral therapy regimen; a neutrophilic granulocyte absolute count <500/mm^3.
Has a history of hepatitis B virus (HBV) or hepatitis C virus (HCV) with cirrhosis, end-stage liver disease, hepatocellular carcinoma, aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) >3X upper limit of normal at screening.
Has a platelet count <100,000/μL or received a platelet transfusion in the 5 days prior to randomization.
Is taking or is anticipated to require any prohibited therapies.
Is unwilling to abstain from participating in another interventional clinical study through Day 29 with an investigational compound or device, including those for COVID-19 therapeutics.
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 with a recent history of mechanical ventilation, or participants with conditions that could limit gastrointestinal absorption of capsule contents.

Sites / Locations

Phoenix Medical Group ( Site 1822)
Ruane Clinical Research Group, Inc. ( Site 2406)
Men's Health Foundation ( Site 1820)
Carbon Health Technologies Inc ( Site 2505)
UC Davis Medical Center ( Site 1833)
Emerson Clinical Research Institute ( Site 1828)
JEM Research Institute ( Site 2508)
Midway Immunology and Research Center ( Site 1837)
Indago Research & Health Center, Inc ( Site 1809)
Advanced Research For Health Improvement LLC ( Site 1816)
Advanced Medical Research, LLC ( Site 1864)
Advanced Research For Health Improvement LLC ( Site 1813)
Bliss Healthcare Services ( Site 1847)
Javara Inc. ( Site 1869)
IACT Health ( Site 1818)
Javara Inc. ( Site 1868)
Loretto Hospital ( Site 1886)
Jadestone Clinical Research, LLC ( Site 2502)
Michigan Center of Medical Research ( Site 2500)
University of Nebraska Medical Center ( Site 2414)
Amici Clinical Research LLC ( Site 2507)
University of New Mexico, Health Sciences Center ( Site 1819)
AXCES Research Group ( Site 2418)
Saint Hope Foundation, Inc. ( Site 1830)
The Crofoot Research Center, Inc. ( Site 1812)
Javara Inc. ( Site 1866)
Clinical Research Partners, LLC. ( Site 2503)
Swedish Medical Center First Hill ( Site 1807)
Fred Hutchinson Cancer Center ( Site 1829)
Multicare Health System ( Site 1811)
Multicare Health System ( Site 1814)
Medical College Of Wisconsin ( Site 2510)
Clinica Independencia ( Site 3400)
Instituto Medico de la Fundacion Estudios Clinicos ( Site 3401)
Chronos Pesquisa Clínica ( Site 0155)
Santa Casa de Misericordia de Belo Horizonte ( Site 0150)
Hospital de Clinicas da Universidade Federal do Parana ( Site 0154)
Hospital Tacchini ( Site 0157)
FUNFARME Hospital de Base Centro Integrado de Pesquisa ( Site 0151)
Instituto de Infectologia Emilio Ribas ( Site 0153)
Centro de Pesquisa Clinica II - ICHC - FMUSP ( Site 0152)
Hamilton Medical Research Group ( Site 0207)
University Health Network - Toronto General Hospital ( Site 0201)
Centre Hospitalier de l Universite de Montreal - CHUM ( Site 0200)
McGill University Health Centre ( Site 0204)
Servicios Medicos Urumed ( Site 0307)
Clinical Research Chile SpA ( Site 0308)
Clinica Universidad de los Andes ( Site 0302)
Fundacion Arturo Lopez Perez ( Site 0305)
Espacio EME ( Site 0304)
Centro de Investigacion Clinica UC CICUC ( Site 0309)
Clinica Bicentenario Spa ( Site 0306)
Hospital Pablo Tobon Uribe ( Site 0405)
Centro Cientifico Asistencial Jose Luis Accini ( Site 0416)
Clinica de la Costa Ltda. ( Site 0403)
Oncomedica S.A. ( Site 0407)
Caja de Compensación Familiar CAFAM. Sede Centro de Atención en Salud CAFAM Floresta ( Site 0406)
Centro de Atencion e Investigacion Medica CAIMED ( Site 0413)
Fundacion Santa Fe de Bogota ( Site 0412)
Fundacion Cardiovascular de Colombia ( Site 0402)
Fundacion Valle del Lili ( Site 0401)
Centro Medico Imbanaco de Cali S.A ( Site 0415)
National Center for allergies and chest ( Site 3320)
National Hepatology & Tropical Medicine Research Institute (NHTMRI) ( Site 3300)
Abbassia Chest Hospital ( Site 3340)
Abbassia Fever Hospital ( Site 3330)
Helwan Fever Hospital ( Site 3350)
Hopital Bichat Claude Bernard ( Site 0503)
Hopital Saint Joseph ( Site 0513)
Groupe Hospitalier Pellegrin ( Site 0511)
CHU de la Reunion - Groupe Hospitalier Sud ( Site 0514)
C.H.U. de Toulouse Hopital Purpan ( Site 0501)
Centre Hospitalier de Tourcoing ( Site 0502)
CHU Hopital Saint Antoine ( Site 0505)
Pitie Salpetriere University Hospital-Infectious Disease - Tropical Diseases ( Site 0504)
Universitaetsklinikum Frankfurt ( Site 2302)
Universitaetsklinikum Essen ( Site 2305)
ZIBP-Zentrum fur Infektiologie Berlin Prenzlauer Berg GmbH ( Site 2301)
ICH Study Center GmbH & Co.KG ( Site 2306)
Clínica Médica Especializada en Pediatría e Infectología Pediátrica - Dr. Mario Melgar ( Site 2601)
Clinica Privada Dr. Jose Francisco Flores Lopez ( Site 2600)
Hadassah Medical Center. Ein Kerem ( Site 2100)
Asl Napoli 1 Centro ( Site 0610)
Policlinico S. Orsola-Malpighi ( Site 0604)
IRCCS Ospedale Policlinico San Martino ( Site 0603)
Fondazione IRCCS Ca' Granda-Ospedale Maggiore Policlinico ( Site 0606)
Ospedale San Raffaele ( Site 0605)
ASST Fatebenefratelli-Ospedale Sacco ( Site 0601)
Ospedale Niguarda ( Site 0608)
AOU Policlinico Paolo Giaccone ( Site 0609)
Istituto Nazionale per Le Malattie Infettive Lazzaro Spallanzani ( Site 0600)
Ospedale Amedeo di Savoia, Malattie Infettive ( Site 0602)
Azienda Sanitaria Universitaria Friuli Centrale -ASU FC ( Site 0607)
Chiba Aoba Municipal Hospital ( Site 0702)
Den-en-chofu family clinic ( Site 0701)
Center Hospital of the National Center for Global Health and Medicine ( Site 0700)
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran ( Site 0802)
CAIMED México ( Site 0814)
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)
Centro de Investigacion y Avances Medicos Especializados -CIAME ( Site 0810)
Köhler & Milstein Research S.A. de C.V. ( Site 0809)
ICARO Investigaciones en Medicina ( Site 0812)
Oaxaca Site Management Organization S.C. ( Site 0811)
Clinical Research Institute S.C. ( Site 0813)
Arké SMO S.A de C.V ( Site 0808)
Lung Center of the Philippines ( Site 0902)
Quirino Memorial Medical Center ( Site 0903)
NZOZ Centrum Medyczne Szpital Swietej Rodziny ( Site 1006)
Krakowskie Centrum Medyczne Sp. z o.o ( Site 1008)
Centrum Medyczne Pulawska Sp. z o.o. ( Site 1007)
Centrum Medyczne MEDYK Sp. z o.o. Sp.k. ( Site 1009)
Central Scientific Research Institute of Epidemiology ( Site 1104)
Open Joint Stock Company Clinical and Diagnostic Center Euromedservice ( Site 1122)
Hadassah Medical LTD ( Site 1124)
Central Clinical Hospital with Polyclinic ( Site 1105)
City Hospital No.33 of Leninsky ( Site 1127)
SPb SBHI City outpatient clinic 112 ( Site 1128)
Medical Research Institute LLC ( Site 1116)
Smorodintsev Research Institute of Influenza ( Site 1129)
SPb SBHI City outpatient clinic 4 ( Site 1131)
Strategic Medical System LLC ( Site 1114)
St.Petersburg Outpatient Clinic No. 109 ( Site 1119)
Limited liability company "Scientific research center Eco-safety" ( Site 1117)
City Polyclinic N44 ( Site 1130)
Smolensk State Medical University ( Site 1110)
Republican Clinical Infectious Hospital n.a. A.F. Agafonov ( Site 1100)
IATROS International ( Site 1212)
Right To Care Research - Esizayo ( Site 1229)
Mzansi Ethical Research Centre ( Site 1225)
Jongaie Research ( Site 1223)
Wits Baragwanath Clinical Trial Site ( Site 1214)
Enhancing Care Foundation-DICRS ( Site 1216)
Limpopo Clinical Research Initiative ( Site 1227)
TREAD Research ( Site 1211)
Desmond Tutu HIV Foundation Clinical Trial Unit ( Site 1219)
Be Part Yoluntu Centre ( Site 1218)
Paarl Research Centre ( Site 1228)
Clinical Projects Research Centre ( Site 1215)
CAP Centelles ( Site 1308)
Hospital General Universitario Gregorio Maranon ( Site 1302)
Fundacion Hospital Alcorcon de Madrid ( Site 1314)
CAP Sardenya - Barcelona ( Site 1307)
Hospital Clinic ( Site 1304)
Hospital Universitari Germans Trias i Pujol ( Site 1303)
Hospital Universitario Infanta Leonor ( Site 1310)
Hospital Universitario Ramon y Cajal ( Site 1301)
Hospital Universitario La Paz ( Site 1300)
Karolinska Universitetssjukhuset Solna ( Site 1400)
ClinSmart Sweden AB.Uppsala ( Site 1402)
Sahlgrenska Universitetssjukhuset Ostra ( Site 1401)
National Taiwan University Hospital ( Site 3100)
Taoyuan General Hospital ( Site 3101)
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)
Non profit municipal enterprise City hospital student of Kharkiv city council ( Site 1621)
PCNE Kharkiv City polyclinic 9 of the Kharkiv City Council ( Site 1627)
Limited Liability Company Medical center Healthy Happy ( Site 1625)
LLC "Adonis plus" ( Site 1619)
Kyiv railway clinical hospital 2 of Branch Health center ( Site 1602)
ARTEM. State Holding Company ( Site 1618)
Municipal Noncommercial Enterprise Lviv 4th City Clinical Hospital ( Site 1622)
MNCE -Odesa regional clinical hospital of Odesa regional council ( Site 1626)
Municipal Enterprise Poltava Regional Clinical Infectious Hospital ( Site 1614)
Medical Center Health Clinic ( Site 1623)
The Adam Practice ( Site 1708)
Accellacare South London Quality Research Centre ( Site 1709)
Royal Free London NHS Foundation Trust ( Site 1700)
King's College Hospital ( Site 1707)
Layton Medical Centre ( Site 1705)
Newcastle upon Tyne Hospitals NHS Foundation Trust ( Site 1704)

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

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 800 mg

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)

800 mg 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

Percentage of Participants Who Were Hospitalized and/or Died Through Day 29 (Primary Pre-specified Analysis)

The percentage of participants who were hospitalized and/or died through Day 29 is presented. Hospitalization (all cause) is defined as at least 24 hours of acute care in a hospital or similar acute care facility. Death was due to any cause. Any participants with an unknown survival status at Day 29 were treated as failure. The analysis in Part 2 was based on all participants enrolled by the pre-specified futility/early efficacy analysis and was used for demonstration of superiority to placebo for the primary efficacy outcome measure.

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 who discontinued study intervention 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

Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Cough

Time to sustained resolution or improvement of the targeted sign/symptom was defined as the number of days from randomization to the first of three consecutive days when resolution or improvement of the targeted sign/symptom was demonstrated and did not worsen by Day 29. The median number of days from randomization to the first day on or before study Day 29 for sustained resolution or improvement is presented. Per protocol, participants without the targeted sign/symptom reported at randomization were not included in the analysis.

Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Sore Throat

Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Nasal Congestion

Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Rhinorrhea

Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Shortness of Breath or Difficulty Breathing

Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Muscles or Body Aches

Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Fatigue

Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Feeling Hot or Feverish

Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Chills

Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Headache

Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Nausea

Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Vomiting

Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Diarrhea

Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Loss of Taste

Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Loss of Smell

Time to Progression of Each Targeted COVID-19 Sign/Symptom - Cough

Time to progression of the targeted sign/symptom was defined as the number of days from randomization to the first of two consecutive days when the targeted sign/symptom was worsened. The median number of days from randomization to the first day on or before study Day 29 for progression/worsening is presented. Per protocol, participants with symptoms reported at randomization as severe for the targeted sign/symptom were not included in the analysis.

Time to Progression of Each Targeted COVID-19 Sign/Symptom - Sore Throat

Time to Progression of Each Targeted COVID-19 Sign/Symptom - Nasal Congestion

Time to Progression of Each Targeted COVID-19 Sign/Symptom - Rhinorrhea

Time to Progression of Each Targeted COVID-19 Sign/Symptom - Shortness of Breath or Difficulty Breathing

Time to Progression of Each Targeted COVID-19 Sign/Symptom - Muscle or Body Aches

Time to Progression of Each Targeted COVID-19 Sign/Symptom - Fatigue

Time to Progression of Each Targeted COVID-19 Sign/Symptom - Feeling Hot or Feverish

Time to Progression of Each Targeted COVID-19 Sign/Symptom - Chills

Time to Progression of Each Targeted COVID-19 Sign/Symptom - Headache

Time to Progression of Each Targeted COVID-19 Sign/Symptom - Nausea

Time to Progression of Each Targeted COVID-19 Sign/Symptom - Vomiting

Time to Progression of Each Targeted COVID-19 Sign/Symptom - Diarrhea

Time to Progression of Each Targeted COVID-19 Sign/Symptom - Loss of Taste

Time to Progression of Each Targeted COVID-19 Sign/Symptom - Loss of Smell

Number of Participants With Responses 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.

Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on End of Treatment (EOT [Day 5])

Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 10

Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 15

Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 29

Full Information

NCT ID

NCT04575597

First Posted

September 30, 2020

Last Updated

June 5, 2023

Sponsor

Merck Sharp & Dohme LLC

1. Study Identification

Unique Protocol Identification Number

NCT04575597

Brief Title

Efficacy and Safety of Molnupiravir (MK-4482) in Non-Hospitalized Adult Participants With COVID-19 (MK-4482-002)

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Completed

Study Start Date

October 19, 2020 (Actual)

Primary Completion Date

May 5, 2022 (Actual)

Study Completion Date

May 5, 2022 (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

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 percentage of participants who are hospitalized and/or die through Day 29

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

1735 (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 800 mg

Arm Type

Experimental

Arm Description

800 mg 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

Other Intervention Name(s)

MK-4482

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

Percentage of Participants Who Were Hospitalized and/or Died Through Day 29 (Primary Pre-specified Analysis)

Description

Time Frame

Up to 29 days

Title

Number of Participants With an Adverse Event (AE)

Description

Time Frame

Up to 318 days

Title

Number of Participants Who Discontinued Study Intervention Due to an AE

Description

Time Frame

Up to 5 days

Secondary Outcome Measure Information:

Title

Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Cough

Description

Time Frame

Up to 29 days

Title

Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Sore Throat

Description

Time Frame

Up to 29 days

Title

Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Nasal Congestion

Description

Time Frame

Up to 29 days

Title

Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Rhinorrhea

Description

Time Frame

Up to 29 days

Title

Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Shortness of Breath or Difficulty Breathing

Description

Time Frame

Up to 29 days

Title

Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Muscles or Body Aches

Description

Time Frame

Up to 29 days

Title

Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Fatigue

Description

Time Frame

Up to 29 days

Title

Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Feeling Hot or Feverish

Description

Time Frame

Up to 29 days

Title

Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Chills

Description

Time Frame

Up to 29 days

Title

Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Headache

Description

Time Frame

Up to 29 days

Title

Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Nausea

Description

Time Frame

Up to 29 days

Title

Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Vomiting

Description

Time Frame

Up to 29 days

Title

Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Diarrhea

Description

Time Frame

Up to 29 days

Title

Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Loss of Taste

Description

Time Frame

Up to 29 days

Title

Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Loss of Smell

Description

Time Frame

Up to 29 days

Title

Time to Progression of Each Targeted COVID-19 Sign/Symptom - Cough

Description

Time Frame

Up to 29 days

Title

Time to Progression of Each Targeted COVID-19 Sign/Symptom - Sore Throat

Description

Time Frame

Up to 29 days

Title

Time to Progression of Each Targeted COVID-19 Sign/Symptom - Nasal Congestion

Description

Time Frame

Up to 29 days

Title

Time to Progression of Each Targeted COVID-19 Sign/Symptom - Rhinorrhea

Description

Time Frame

Up to 29 days

Title

Time to Progression of Each Targeted COVID-19 Sign/Symptom - Shortness of Breath or Difficulty Breathing

Description

Time Frame

Up to 29 days

Title

Time to Progression of Each Targeted COVID-19 Sign/Symptom - Muscle or Body Aches

Description

Time Frame

Up to 29 days

Title

Time to Progression of Each Targeted COVID-19 Sign/Symptom - Fatigue

Description

Time Frame

Up to 29 days

Title

Time to Progression of Each Targeted COVID-19 Sign/Symptom - Feeling Hot or Feverish

Description

Time Frame

Up to 29 days

Title

Time to Progression of Each Targeted COVID-19 Sign/Symptom - Chills

Description

Time Frame

Up to 29 days

Title

Time to Progression of Each Targeted COVID-19 Sign/Symptom - Headache

Description

Time Frame

Up to 29 days

Title

Time to Progression of Each Targeted COVID-19 Sign/Symptom - Nausea

Description

Time Frame

Up to 29 days

Title

Time to Progression of Each Targeted COVID-19 Sign/Symptom - Vomiting

Description

Time Frame

Up to 29 days

Title

Time to Progression of Each Targeted COVID-19 Sign/Symptom - Diarrhea

Description

Time Frame

Up to 29 days

Title

Time to Progression of Each Targeted COVID-19 Sign/Symptom - Loss of Taste

Description

Time Frame

Up to 29 days

Title

Time to Progression of Each Targeted COVID-19 Sign/Symptom - Loss of Smell

Description

Time Frame

Up to 29 days

Title

Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 3

Description

Time Frame

Day 3

Title

Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on End of Treatment (EOT [Day 5])

Description

Time Frame

EOT (Day 5)

Title

Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 10

Description

Time Frame

Day 10

Title

Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 15

Description

Time Frame

Day 15

Title

Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 29

Description

Time Frame

Day 29

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Has documentation of laboratory confirmed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection with sample collection ≤5 days prior to the day of randomization. PCR is the preferred method; however with evolving approaches to laboratory confirmation of SARS-CoV-2 infection, other molecular or antigen tests that detect viral ribonucleic acid (RNA) or protein are allowed if authorized for use in the country. Serological tests that detect host antibodies generated in response to recent or prior infection are not allowed. Had initial onset of signs/symptoms attributable to COVID-19 for ≤5 days prior to the day of randomization and at least 1 of the following sign/symptom attributable to COVID-19 on the day of randomization. Has mild or moderate COVID-19. Has at least 1 characteristic or underlying medical condition associated with an increased risk of severe illness from COVID-19. Males agree to the following during the intervention period and for at least 4 days after the last dose of study intervention: 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 at least 4 days after the last dose of study intervention; a WOCBP must have a negative highly sensitive pregnancy test (urine or serum test is required) within 24 hours before the first dose of study intervention. Exclusion Criteria: Is currently hospitalized or is expected to need hospitalization for COVID-19 within 48 hours of randomization. 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 (regardless of CD4 count) or an AIDS-defining illness in the past 6 months, participants with HIV may only be enrolled if on a stable antiretroviral therapy regimen; a neutrophilic granulocyte absolute count <500/mm^3. Has a history of hepatitis B virus (HBV) or hepatitis C virus (HCV) with cirrhosis, end-stage liver disease, hepatocellular carcinoma, aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) >3X upper limit of normal at screening. Has a platelet count <100,000/μL or received a platelet transfusion in the 5 days prior to randomization. Is taking or is anticipated to require any prohibited therapies. Is unwilling to abstain from participating in another interventional clinical study through Day 29 with an investigational compound or device, including those for COVID-19 therapeutics. 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 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

Phoenix Medical Group ( Site 1822)

City

Peoria

State/Province

Arizona

ZIP/Postal Code

85381

Country

United States

Facility Name

Ruane Clinical Research Group, Inc. ( Site 2406)

City

Los Angeles

State/Province

California

ZIP/Postal Code

90036

Country

United States

Facility Name

Men's Health Foundation ( Site 1820)

City

Los Angeles

State/Province

California

ZIP/Postal Code

90069

Country

United States

Facility Name

Carbon Health Technologies Inc ( Site 2505)

City

North Hollywood

State/Province

California

ZIP/Postal Code

91606

Country

United States

Facility Name

UC Davis Medical Center ( Site 1833)

City

Sacramento

State/Province

California

ZIP/Postal Code

95817

Country

United States

Facility Name

Emerson Clinical Research Institute ( Site 1828)

City

Washington

State/Province

District of Columbia

ZIP/Postal Code

20011

Country

United States

Facility Name

JEM Research Institute ( Site 2508)

City

Atlantis

State/Province

Florida

ZIP/Postal Code

33462

Country

United States

Facility Name

Midway Immunology and Research Center ( Site 1837)

City

Fort Pierce

State/Province

Florida

ZIP/Postal Code

34982

Country

United States

Facility Name

Indago Research & Health Center, Inc ( Site 1809)

City

Hialeah

State/Province

Florida

ZIP/Postal Code

33012

Country

United States

Facility Name

Advanced Research For Health Improvement LLC ( Site 1816)

City

Immokalee

State/Province

Florida

ZIP/Postal Code

34142

Country

United States

Facility Name

Advanced Medical Research, LLC ( Site 1864)

City

Miami

State/Province

Florida

ZIP/Postal Code

33174

Country

United States

Facility Name

Advanced Research For Health Improvement LLC ( Site 1813)

City

Naples

State/Province

Florida

ZIP/Postal Code

34102

Country

United States

Facility Name

Bliss Healthcare Services ( Site 1847)

City

Orlando

State/Province

Florida

ZIP/Postal Code

32806

Country

United States

Facility Name

Javara Inc. ( Site 1869)

City

Albany

State/Province

Georgia

ZIP/Postal Code

31707

Country

United States

Facility Name

IACT Health ( Site 1818)

City

Columbus

State/Province

Georgia

ZIP/Postal Code

31904

Country

United States

Facility Name

Javara Inc. ( Site 1868)

City

Fayetteville

State/Province

Georgia

ZIP/Postal Code

30214

Country

United States

Facility Name

Loretto Hospital ( Site 1886)

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60644

Country

United States

Facility Name

Jadestone Clinical Research, LLC ( Site 2502)

City

Laurel

State/Province

Maryland

ZIP/Postal Code

20708

Country

United States

Facility Name

Michigan Center of Medical Research ( Site 2500)

City

Farmington Hills

State/Province

Michigan

ZIP/Postal Code

48334

Country

United States

Facility Name

University of Nebraska Medical Center ( Site 2414)

City

Omaha

State/Province

Nebraska

ZIP/Postal Code

68198

Country

United States

Facility Name

Amici Clinical Research LLC ( Site 2507)

City

Raritan

State/Province

New Jersey

ZIP/Postal Code

08869

Country

United States

Facility Name

University of New Mexico, Health Sciences Center ( Site 1819)

City

Albuquerque

State/Province

New Mexico

ZIP/Postal Code

87131

Country

United States

Facility Name

AXCES Research Group ( Site 2418)

City

Santa Fe

State/Province

New Mexico

ZIP/Postal Code

87505

Country

United States

Facility Name

Saint Hope Foundation, Inc. ( Site 1830)

City

Bellaire

State/Province

Texas

ZIP/Postal Code

77401

Country

United States

Facility Name

The Crofoot Research Center, Inc. ( Site 1812)

City

Houston

State/Province

Texas

ZIP/Postal Code

77098

Country

United States

Facility Name

Javara Inc. ( Site 1866)

City

Sugar Land

State/Province

Texas

ZIP/Postal Code

77478

Country

United States

Facility Name

Clinical Research Partners, LLC. ( Site 2503)

City

Richmond

State/Province

Virginia

ZIP/Postal Code

23226

Country

United States

Facility Name

Swedish Medical Center First Hill ( Site 1807)

City

Seattle

State/Province

Washington

ZIP/Postal Code

98104

Country

United States

Facility Name

Fred Hutchinson Cancer Center ( Site 1829)

City

Seattle

State/Province

Washington

ZIP/Postal Code

98109

Country

United States

Facility Name

Multicare Health System ( Site 1811)

City

Spokane

State/Province

Washington

ZIP/Postal Code

99204

Country

United States

Facility Name

Multicare Health System ( Site 1814)

City

University Place

State/Province

Washington

ZIP/Postal Code

98466

Country

United States

Facility Name

Medical College Of Wisconsin ( Site 2510)

City

Milwaukee

State/Province

Wisconsin

ZIP/Postal Code

53226

Country

United States

Facility Name

Clinica Independencia ( Site 3400)

City

Vicente Lopez

State/Province

Buenos Aires

ZIP/Postal Code

B1605FRE

Country

Argentina

Facility Name

Instituto Medico de la Fundacion Estudios Clinicos ( Site 3401)

City

Rosario

State/Province

Santa Fe

ZIP/Postal Code

2000

Country

Argentina

Facility Name

Chronos Pesquisa Clínica ( Site 0155)

City

Brasilia

State/Province

Distrito Federal

ZIP/Postal Code

72145-424

Country

Brazil

Facility Name

Santa Casa de Misericordia de Belo Horizonte ( Site 0150)

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 0154)

City

Curitiba

State/Province

Parana

ZIP/Postal Code

80060-900

Country

Brazil

Facility Name

Hospital Tacchini ( Site 0157)

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 0151)

City

Sao Jose do Rio Preto

State/Province

Sao Paulo

ZIP/Postal Code

15090-000

Country

Brazil

Facility Name

Instituto de Infectologia Emilio Ribas ( Site 0153)

City

Sao Paulo

ZIP/Postal Code

01246-900

Country

Brazil

Facility Name

Centro de Pesquisa Clinica II - ICHC - FMUSP ( Site 0152)

City

Sao Paulo

ZIP/Postal Code

05403-010

Country

Brazil

Facility Name

Hamilton Medical Research Group ( Site 0207)

City

Hamilton

State/Province

Ontario

ZIP/Postal Code

L8M1K7

Country

Canada

Facility Name

University Health Network - Toronto General Hospital ( Site 0201)

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5G 2N2

Country

Canada

Facility Name

Centre Hospitalier de l Universite de Montreal - CHUM ( Site 0200)

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H2X 3E4

Country

Canada

Facility Name

McGill University Health Centre ( Site 0204)

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H4A 3J1

Country

Canada

Facility Name

Servicios Medicos Urumed ( Site 0307)

City

Rancagua

State/Province

Lbtdr Gen Bernardo O Higgins

ZIP/Postal Code

2852424

Country

Chile

Facility Name

Clinical Research Chile SpA ( Site 0308)

City

Valdivia

State/Province

Los Rios

ZIP/Postal Code

5110683

Country

Chile

Facility Name

Clinica Universidad de los Andes ( Site 0302)

City

Santiago

State/Province

Region M. De Santiago

ZIP/Postal Code

2820945

Country

Chile

Facility Name

Fundacion Arturo Lopez Perez ( Site 0305)

City

Santiago

State/Province

Region M. De Santiago

ZIP/Postal Code

7500921

Country

Chile

Facility Name

Espacio EME ( Site 0304)

City

Santiago

State/Province

Region M. De Santiago

ZIP/Postal Code

7770086

Country

Chile

Facility Name

Centro de Investigacion Clinica UC CICUC ( Site 0309)

City

Santiago

State/Province

Region M. De Santiago

ZIP/Postal Code

8330034

Country

Chile

Facility Name

Clinica Bicentenario Spa ( Site 0306)

City

Santiago

State/Province

Region M. De Santiago

ZIP/Postal Code

9160000

Country

Chile

Facility Name

Hospital Pablo Tobon Uribe ( Site 0405)

City

Medellin

State/Province

Antioquia

ZIP/Postal Code

050034

Country

Colombia

Facility Name

Centro Cientifico Asistencial Jose Luis Accini ( Site 0416)

City

Barranquilla

State/Province

Atlantico

ZIP/Postal Code

080020

Country

Colombia

Facility Name

Clinica de la Costa Ltda. ( Site 0403)

City

Barranquilla

State/Province

Atlantico

ZIP/Postal Code

080020

Country

Colombia

Facility Name

Oncomedica S.A. ( Site 0407)

City

Monteria

State/Province

Cordoba

ZIP/Postal Code

230002

Country

Colombia

Facility Name

Caja de Compensación Familiar CAFAM. Sede Centro de Atención en Salud CAFAM Floresta ( Site 0406)

City

Bogota

State/Province

Cundinamarca

ZIP/Postal Code

111211

Country

Colombia

Facility Name

Centro de Atencion e Investigacion Medica CAIMED ( Site 0413)

City

Bogota

State/Province

Cundinamarca

ZIP/Postal Code

111611

Country

Colombia

Facility Name

Fundacion Santa Fe de Bogota ( Site 0412)

City

Bogota

State/Province

Distrito Capital De Bogota

ZIP/Postal Code

110111

Country

Colombia

Facility Name

Fundacion Cardiovascular de Colombia ( Site 0402)

City

Bucaramanca

State/Province

Santander

ZIP/Postal Code

680003

Country

Colombia

Facility Name

Fundacion Valle del Lili ( Site 0401)

City

Cali

State/Province

Valle Del Cauca

ZIP/Postal Code

760032

Country

Colombia

Facility Name

Centro Medico Imbanaco de Cali S.A ( Site 0415)

City

Cali

State/Province

Valle Del Cauca

ZIP/Postal Code

760042

Country

Colombia

Facility Name

National Center for allergies and chest ( Site 3320)

City

Giza

State/Province

Al Jizah

ZIP/Postal Code

12651

Country

Egypt

Facility Name

National Hepatology & Tropical Medicine Research Institute (NHTMRI) ( Site 3300)

City

Cairo

State/Province

Al Qahirah

ZIP/Postal Code

11562

Country

Egypt

Facility Name

Abbassia Chest Hospital ( Site 3340)

City

Cairo

State/Province

Al Qahirah

ZIP/Postal Code

11591

Country

Egypt

Facility Name

Abbassia Fever Hospital ( Site 3330)

City

Cairo

State/Province

Al Qahirah

ZIP/Postal Code

11591

Country

Egypt

Facility Name

Helwan Fever Hospital ( Site 3350)

City

Cairo

State/Province

Al Qahirah

ZIP/Postal Code

12899

Country

Egypt

Facility Name

Hopital Bichat Claude Bernard ( Site 0503)

City

Paris

State/Province

Ain

ZIP/Postal Code

75018

Country

France

Facility Name

Hopital Saint Joseph ( Site 0513)

City

Marseille

State/Province

Bouches-du-Rhone

ZIP/Postal Code

13285

Country

France

Facility Name

Groupe Hospitalier Pellegrin ( Site 0511)

City

Bordeaux

State/Province

Gironde

ZIP/Postal Code

33000

Country

France

Facility Name

CHU de la Reunion - Groupe Hospitalier Sud ( Site 0514)

City

Saint Pierre Cedex

State/Province

La Reunion

ZIP/Postal Code

97448

Country

France

Facility Name

C.H.U. de Toulouse Hopital 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

Pitie Salpetriere University Hospital-Infectious Disease - Tropical Diseases ( Site 0504)

City

Paris

ZIP/Postal Code

75013

Country

France

Facility Name

Universitaetsklinikum Frankfurt ( Site 2302)

City

Frankfurt a main

State/Province

Hessen

ZIP/Postal Code

60590

Country

Germany

Facility Name

Universitaetsklinikum Essen ( Site 2305)

City

Essen

State/Province

Nordrhein-Westfalen

ZIP/Postal Code

45147

Country

Germany

Facility Name

ZIBP-Zentrum fur Infektiologie Berlin Prenzlauer Berg GmbH ( Site 2301)

City

Berlin

ZIP/Postal Code

10439

Country

Germany

Facility Name

ICH Study Center GmbH & Co.KG ( Site 2306)

City

Hamburg

ZIP/Postal Code

20146

Country

Germany

Facility Name

Clínica Médica Especializada en Pediatría e Infectología Pediátrica - Dr. Mario Melgar ( Site 2601)

City

Guatemala

ZIP/Postal Code

01009

Country

Guatemala

Facility Name

Clinica Privada Dr. Jose Francisco Flores Lopez ( Site 2600)

City

Guatemala

ZIP/Postal Code

01015

Country

Guatemala

Facility Name

Hadassah Medical Center. Ein Kerem ( Site 2100)

City

Jerusalem

ZIP/Postal Code

9112001

Country

Israel

Facility Name

Asl Napoli 1 Centro ( Site 0610)

City

Napoles

State/Province

Napoli

ZIP/Postal Code

80145

Country

Italy

Facility Name

Policlinico S. Orsola-Malpighi ( Site 0604)

City

Bologna

ZIP/Postal Code

40138

Country

Italy

Facility Name

IRCCS Ospedale Policlinico San Martino ( Site 0603)

City

Genova

ZIP/Postal Code

16132

Country

Italy

Facility Name

Fondazione IRCCS Ca' Granda-Ospedale Maggiore Policlinico ( Site 0606)

City

Milano

ZIP/Postal Code

20122

Country

Italy

Facility Name

Ospedale San Raffaele ( Site 0605)

City

Milano

ZIP/Postal Code

20127

Country

Italy

Facility Name

ASST Fatebenefratelli-Ospedale Sacco ( Site 0601)

City

Milano

ZIP/Postal Code

20157

Country

Italy

Facility Name

Ospedale Niguarda ( Site 0608)

City

Milano

ZIP/Postal Code

20162

Country

Italy

Facility Name

AOU Policlinico Paolo Giaccone ( Site 0609)

City

Palermo

ZIP/Postal Code

90127

Country

Italy

Facility Name

Istituto Nazionale per Le Malattie Infettive Lazzaro Spallanzani ( Site 0600)

City

Roma

ZIP/Postal Code

00149

Country

Italy

Facility Name

Ospedale Amedeo di Savoia, Malattie Infettive ( Site 0602)

City

Torino

ZIP/Postal Code

10149

Country

Italy

Facility Name

Azienda Sanitaria Universitaria Friuli Centrale -ASU FC ( Site 0607)

City

Udine

ZIP/Postal Code

33100

Country

Italy

Facility Name

Chiba Aoba Municipal Hospital ( Site 0702)

City

Chiba

ZIP/Postal Code

260-0852

Country

Japan

Facility Name

Den-en-chofu family clinic ( Site 0701)

City

Tokyo

ZIP/Postal Code

145-0071

Country

Japan

Facility Name

Center Hospital of the National Center for Global Health and Medicine ( Site 0700)

City

Tokyo

ZIP/Postal Code

162-8655

Country

Japan

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

CAIMED México ( Site 0814)

City

Mexico City

State/Province

Distrito Federal

ZIP/Postal Code

06760

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

Centro de Investigacion y Avances Medicos Especializados -CIAME ( Site 0810)

City

Cancun

State/Province

Quintana Roo

ZIP/Postal Code

70500

Country

Mexico

Facility Name

Köhler & Milstein Research S.A. de C.V. ( Site 0809)

City

Merida

State/Province

Yucatan

ZIP/Postal Code

97070

Country

Mexico

Facility Name

ICARO Investigaciones en Medicina ( Site 0812)

City

Chihuahua

ZIP/Postal Code

31000

Country

Mexico

Facility Name

Oaxaca Site Management Organization S.C. ( Site 0811)

City

Oaxaca

ZIP/Postal Code

68000

Country

Mexico

Facility Name

Clinical Research Institute S.C. ( Site 0813)

City

Tlalnepantla de Baz

ZIP/Postal Code

54055

Country

Mexico

Facility Name

Arké SMO S.A de C.V ( Site 0808)

City

Veracruz

ZIP/Postal Code

91910

Country

Mexico

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

Quirino Memorial Medical Center ( Site 0903)

City

Quezon City

State/Province

National Capital Region

ZIP/Postal Code

1109

Country

Philippines

Facility Name

NZOZ Centrum Medyczne Szpital Swietej Rodziny ( Site 1006)

City

Lodz

State/Province

Lodzkie

ZIP/Postal Code

90-302

Country

Poland

Facility Name

Krakowskie Centrum Medyczne Sp. z o.o ( Site 1008)

City

Krakow

State/Province

Malopolskie

ZIP/Postal Code

31-501

Country

Poland

Facility Name

Centrum Medyczne Pulawska Sp. z o.o. ( Site 1007)

City

Piaseczno

State/Province

Mazowieckie

ZIP/Postal Code

05-500

Country

Poland

Facility Name

Centrum Medyczne MEDYK Sp. z o.o. Sp.k. ( Site 1009)

City

Rzeszow

State/Province

Podkarpackie

ZIP/Postal Code

35-326

Country

Poland

Facility Name

Central Scientific Research Institute of Epidemiology ( Site 1104)

City

Moscow

State/Province

Moskva

ZIP/Postal Code

111123

Country

Russian Federation

Facility Name

Open Joint Stock Company Clinical and Diagnostic Center Euromedservice ( Site 1122)

City

Moscow

State/Province

Moskva

ZIP/Postal Code

115419

Country

Russian Federation

Facility Name

Hadassah Medical LTD ( Site 1124)

City

Moscow

State/Province

Moskva

ZIP/Postal Code

121205

Country

Russian Federation

Facility Name

Central Clinical Hospital with Polyclinic ( Site 1105)

City

Moscow

State/Province

Moskva

ZIP/Postal Code

121359

Country

Russian Federation

Facility Name

City Hospital No.33 of Leninsky ( Site 1127)

City

Nizhny Novgorod

State/Province

Nizhegorodskaya Oblast

ZIP/Postal Code

603076

Country

Russian Federation

Facility Name

SPb SBHI City outpatient clinic 112 ( Site 1128)

City

Saint Petersburg

State/Province

Sankt-Peterburg

ZIP/Postal Code

195427

Country

Russian Federation

Facility Name

Medical Research Institute LLC ( Site 1116)

City

Saint Petersburg

State/Province

Sankt-Peterburg

ZIP/Postal Code

196084

Country

Russian Federation

Facility Name

Smorodintsev Research Institute of Influenza ( Site 1129)

City

Saint Petersburg

State/Province

Sankt-Peterburg

ZIP/Postal Code

197376

Country

Russian Federation

Facility Name

SPb SBHI City outpatient clinic 4 ( Site 1131)

City

Saint Petersburg

State/Province

Sankt-Peterburg

ZIP/Postal Code

199406

Country

Russian Federation

Facility Name

Strategic Medical System LLC ( Site 1114)

City

Saint-Petersburg

State/Province

Sankt-Peterburg

ZIP/Postal Code

192148

Country

Russian Federation

Facility Name

St.Petersburg Outpatient Clinic No. 109 ( Site 1119)

City

Saint-Petersburg

State/Province

Sankt-Peterburg

ZIP/Postal Code

192289

Country

Russian Federation

Facility Name

Limited liability company "Scientific research center Eco-safety" ( Site 1117)

City

Saint-Petersburg

State/Province

Sankt-Peterburg

ZIP/Postal Code

196143

Country

Russian Federation

Facility Name

City Polyclinic N44 ( Site 1130)

City

St.Petersburg

State/Province

Sankt-Peterburg

ZIP/Postal Code

192071

Country

Russian Federation

Facility Name

Smolensk State Medical University ( Site 1110)

City

Smolensk

State/Province

Smolenskaya Oblast

ZIP/Postal Code

214019

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 1212)

City

Bloemfontein

State/Province

Free State

ZIP/Postal Code

9300

Country

South Africa

Facility Name

Right To Care Research - Esizayo ( Site 1229)

City

Johannesburg

State/Province

Gauteng

ZIP/Postal Code

2087

Country

South Africa

Facility Name

Mzansi Ethical Research Centre ( Site 1225)

City

Mpumalanga

State/Province

Gauteng

ZIP/Postal Code

1055

Country

South Africa

Facility Name

Jongaie Research ( Site 1223)

City

Pretoria-West

State/Province

Gauteng

ZIP/Postal Code

0183

Country

South Africa

Facility Name

Wits Baragwanath Clinical Trial Site ( Site 1214)

City

Soweto

State/Province

Gauteng

ZIP/Postal Code

2013

Country

South Africa

Facility Name

Enhancing Care Foundation-DICRS ( Site 1216)

City

Durban

State/Province

Kwazulu-Natal

ZIP/Postal Code

4091

Country

South Africa

Facility Name

Limpopo Clinical Research Initiative ( Site 1227)

City

Thabazimbi

State/Province

Limpopo

ZIP/Postal Code

0380

Country

South Africa

Facility Name

TREAD Research ( Site 1211)

City

Cape Town

State/Province

Western Cape

ZIP/Postal Code

7500

Country

South Africa

Facility Name

Desmond Tutu HIV Foundation Clinical Trial Unit ( Site 1219)

City

Cape Town

State/Province

Western Cape

ZIP/Postal Code

7925

Country

South Africa

Facility Name

Be Part Yoluntu Centre ( Site 1218)

City

Paarl

State/Province

Western Cape

ZIP/Postal Code

7626

Country

South Africa

Facility Name

Paarl Research Centre ( Site 1228)

City

Paarl

State/Province

Western Cape

ZIP/Postal Code

7646

Country

South Africa

Facility Name

Clinical Projects Research Centre ( Site 1215)

City

Worcester

State/Province

Western Cape

ZIP/Postal Code

6850

Country

South Africa

Facility Name

CAP Centelles ( Site 1308)

City

Centelles

State/Province

Barcelona

ZIP/Postal Code

08540

Country

Spain

Facility Name

Hospital General Universitario Gregorio Maranon ( Site 1302)

City

Madrid

State/Province

Madrid, Comunidad De

ZIP/Postal Code

28007

Country

Spain

Facility Name

Fundacion Hospital Alcorcon de Madrid ( Site 1314)

City

Alcorcon

State/Province

Madrid

ZIP/Postal Code

28922

Country

Spain

Facility Name

CAP Sardenya - Barcelona ( Site 1307)

City

Barcelona

ZIP/Postal Code

08025

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 Infanta Leonor ( Site 1310)

City

Madrid

ZIP/Postal Code

28031

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

Karolinska Universitetssjukhuset Solna ( Site 1400)

City

Stockholm

State/Province

Stockholms Lan

ZIP/Postal Code

113 61

Country

Sweden

Facility Name

ClinSmart Sweden AB.Uppsala ( Site 1402)

City

Uppsala

State/Province

Uppsala Lan

ZIP/Postal Code

752 37

Country

Sweden

Facility Name

Sahlgrenska Universitetssjukhuset Ostra ( Site 1401)

City

Goteborg

State/Province

Vastra Gotalands Lan

ZIP/Postal Code

416 85

Country

Sweden

Facility Name

National Taiwan University Hospital ( Site 3100)

City

Taipei

ZIP/Postal Code

100

Country

Taiwan

Facility Name

Taoyuan General Hospital ( Site 3101)

City

Taoyuan

ZIP/Postal Code

33004

Country

Taiwan

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

Non profit municipal enterprise City hospital student of Kharkiv city council ( Site 1621)

City

Kharkiv

State/Province

Kharkivska Oblast

ZIP/Postal Code

61002

Country

Ukraine

Facility Name

PCNE Kharkiv City polyclinic 9 of the Kharkiv City Council ( Site 1627)

City

Kharkiv

State/Province

Kharkivska Oblast

ZIP/Postal Code

61172

Country

Ukraine

Facility Name

Limited Liability Company Medical center Healthy Happy ( Site 1625)

City

Kyiv

State/Province

Kyivska Oblast

ZIP/Postal Code

01033

Country

Ukraine

Facility Name

LLC "Adonis plus" ( Site 1619)

City

Kyiv

State/Province

Kyivska Oblast

ZIP/Postal Code

02002

Country

Ukraine

Facility Name

Kyiv railway clinical hospital 2 of Branch Health center ( Site 1602)

City

Kyiv

State/Province

Kyivska Oblast

ZIP/Postal Code

03049

Country

Ukraine

Facility Name

ARTEM. State Holding Company ( Site 1618)

City

Kyiv

State/Province

Kyivska Oblast

ZIP/Postal Code

04050

Country

Ukraine

Facility Name

Municipal Noncommercial Enterprise Lviv 4th City Clinical Hospital ( Site 1622)

City

Lviv

State/Province

Lvivska Oblast

ZIP/Postal Code

79011

Country

Ukraine

Facility Name

MNCE -Odesa regional clinical hospital of Odesa regional council ( Site 1626)

City

Odessa

State/Province

Odeska Oblast

ZIP/Postal Code

65025

Country

Ukraine

Facility Name

Municipal Enterprise Poltava Regional Clinical Infectious Hospital ( Site 1614)

City

Poltava

State/Province

Poltavska Oblast

ZIP/Postal Code

36011

Country

Ukraine

Facility Name

Medical Center Health Clinic ( Site 1623)

City

Vinnytsia

State/Province

Vinnytska Oblast

ZIP/Postal Code

21009

Country

Ukraine

Facility Name

The Adam Practice ( Site 1708)

City

Poole

State/Province

Dorset

ZIP/Postal Code

BH15 2HX

Country

United Kingdom

Facility Name

Accellacare South London Quality Research Centre ( Site 1709)

City

Orpington

State/Province

Kent

ZIP/Postal Code

BR5 3QG

Country

United Kingdom

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 1707)

City

London

State/Province

London, City Of

ZIP/Postal Code

SE5 9RS

Country

United Kingdom

Facility Name

Layton Medical Centre ( Site 1705)

City

Blackpool

ZIP/Postal Code

FY3 7EN

Country

United Kingdom

Facility Name

Newcastle upon Tyne Hospitals NHS Foundation Trust ( Site 1704)

City

Newcastle upon Tyne

ZIP/Postal Code

NE1 4LP

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

Caraco Y, Crofoot GE, Moncada PA, Galustyan AN, Musungaie DB, Payne B, Kovalchuk E, Gonzalez A, Brown ML, Williams-Diaz A, Gao W, Strizki JM, Grobler J, Du J, Assaid CA, Paschke A, Butterton JR, Johnson MG, De Anda C, for the MOVe-OUT Study Group. Phase 2/3 Trial of Molnupiravir for Treatment of Covid-19 in Nonhospitalized Adults.NEJM Evid 2021;1(2). DOI: 10.1056/EVIDoa2100043. Published December 16, 2021. https://evidence.nejm.org/doi/full/10.1056/EVIDoa2100043

Results Reference

result

PubMed Identifier

35667065

Citation

Johnson MG, Puenpatom A, Moncada PA, Burgess L, Duke ER, Ohmagari N, Wolf T, Bassetti M, Bhagani S, Ghosn J, Zhang Y, Wan H, Williams-Diaz A, Brown ML, Paschke A, De Anda C. Effect of Molnupiravir on Biomarkers, Respiratory Interventions, and Medical Services in COVID-19 : A Randomized, Placebo-Controlled Trial. Ann Intern Med. 2022 Aug;175(8):1126-1134. doi: 10.7326/M22-0729. Epub 2022 Jun 7.

Results Reference

derived

PubMed Identifier

34914868

Citation

Jayk Bernal A, Gomes da Silva MM, Musungaie DB, Kovalchuk E, Gonzalez A, Delos Reyes V, Martin-Quiros A, Caraco Y, Williams-Diaz A, Brown ML, Du J, Pedley A, Assaid C, Strizki J, Grobler JA, Shamsuddin HH, Tipping R, Wan H, Paschke A, Butterton JR, Johnson MG, De Anda C; MOVe-OUT Study Group. Molnupiravir for Oral Treatment of Covid-19 in Nonhospitalized Patients. N Engl J Med. 2022 Feb 10;386(6):509-520. doi: 10.1056/NEJMoa2116044. Epub 2021 Dec 16.

Results Reference

derived

Learn more about this trial

Efficacy and Safety of Molnupiravir (MK-4482) in Non-Hospitalized Adult Participants With COVID-19 (MK-4482-002)

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