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AzTrials

Coronavirus Disease (COVID-19)Phase 2/3NCT04575584

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

A Phase 2/3 study testing Molnupiravir in people with Coronavirus Disease (COVID-19), run by Merck Sharp & Dohme LLC at 89 sites in 17 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Coronavirus Disease (COVID-19)
What is being tested?
Molnupiravir
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
304 participants
Where
89 sitesin 17 countries
Study dates
19 Oct 2020to 11 Aug 2021
Phase
Phase 2/3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

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

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

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 12Show fewer
  • 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

Trial locations and contacts

89 sites in 17 countries.

89 sites in 17 countries

United States20 sites

  • University of New Mexico, Health Sciences Center ( Site 1806)

    Albuquerque, New Mexico, 87131

  • Carolinas Medical Center ( Site 1850)

    Charlotte, North Carolina, 28203

  • Loretto Hospital ( Site 1838)

    Chicago, Illinois, 60644

  • CHRISTUS Institute for Innovation & Advanced Clinical Care ( Site 1864)

    Corpus Christi, Texas, 78404

  • Henry Ford Health System ( Site 1821)

    Detroit, Michigan, 48202-2608

  • Swedish Medical Center ( Site 1812)

    Edmonds, Washington, 98026

  • Sanford Health ( Site 1851)

    Fargo, North Dakota, 58122

  • University Of Florida ( Site 1810)

    Gainesville, Florida, 32610

  • ECU Adult Specialty Care ( Site 1865)

    Greenville, North Carolina, 27834

  • Kaiser Foundation Hospital - South Bay ( Site 1832)

    Harbor City, California, 90710

  • Houston Methodist Hospital ( Site 1863)

    Houston, Texas, 77030

  • University of Mississippi Medical Center ( Site 1846)

    Jackson, Mississippi, 39216

  • Cedars-Sinai Medical Center ( Site 1822)

    Los Angeles, California, 90048

  • Wellstar Kennestone Hospital ( Site 1801)

    Marietta, Georgia, 30060

  • University of Nebraska Medical Center ( Site 1835)

    Omaha, Nebraska, 68198

  • Temple University ( Site 1836)

    Philadelphia, Pennsylvania, 19140

  • Valley Medical Center ( Site 1815)

    Renton, Washington, 98055

  • University of California Davis Health ( Site 1809)

    Sacramento, California, 95817

  • Swedish Medical Center ( Site 1861)

    Seattle, Washington, 98122

  • LSU-HSC Shreveport ( Site 1824)

    Shreveport, Louisiana, 71103

Other trials in United States

Russia8 sites

  • Republican Clinical Infectious Hospital n.a. A.F. Agafonov ( Site 1100)

    Kazan', Tatarstan, Respublika, 420140

  • Krasnogorsk City Hospital Number 1 ( Site 1119)

    Krasnogorsk, Moscow Oblast, 143408

  • City Clinical Hospital #40 ( Site 1109)

    Moscow, Moscow, 108814

  • FSBI Central Hospital with Policlinics ( Site 1105)

    Moscow, Moscow, 121359

  • Moscow Clinical Hospital #52 ( Site 1103)

    Moscow, Moscow, 123182

  • City Hospital #40 ( Site 1113)

    Saint Petersburg, Sankt-Peterburg, 197706

  • City Pokrovskaya hospital ( Site 1116)

    Saint Petersburg, Sankt-Peterburg, 199106

  • City Clinical Hospital #1 ( Site 1112)

    Smolensk, Smolensk Oblast, 214006

Other trials in Russia

Ukraine8 sites

  • Ivano-Frankivsk Regional Clinical Infectious Diseases Hospital ( Site 1605)

    Ivano-Frankivsk, Ivano-Frankivsk Oblast, 76007

  • CNE Central city clinical hospital of Ivano-Frankivsk city council ( Site 1604)

    Ivano-Frankivsk, Ivano-Frankivsk Oblast, 76018

  • MNE Ivano-Frankivsk Regional Phthisiology-Pulmonology Center ( Site 1603)

    Ivano-Frankivsk, Ivano-Frankivsk Oblast, 76018

  • CNPE of Kharkiv RC Regional Clinical Infectious Diseases Hospital ( Site 1606)

    Kharkiv, Kharkiv Oblast, 61000

  • Сommunal non-com. Institution Oleksandrivska clinical hospital Kyiv ( Site 1600)

    Kyiv, Kyivska Oblast, 01601

  • Volyn Regional Clinical Hospital ( Site 1613)

    Lutsk, Volyn Oblast, 43005

  • Odesa City Clinical Infectious Hospital ( Site 1611)

    Odesa, Odesa Oblast, 65023

  • Communal Non-Commercial Enterprise Central City Hospital ( Site 1615)

    Rivne, Rivne Oblast, 33018

Other trials in Ukraine

Colombia6 sites

  • Clinica de la Costa Ltda. ( Site 0402)

    Barranquilla, Atlántico, 080020

  • Hospital Universitario San Ignacio ( Site 0401)

    Bogotá, Bogota D.C., 110231

  • Fundacion Cardiovascular de Colombia ( Site 0403)

    Bucaramanca, Santander Department, 680003

  • Fundacion Valle del Lili ( Site 0400)

    Cali, Valle del Cauca Department, 760032

  • Hospital Pablo Tobon Uribe ( Site 0404)

    Medellín, Antioquia, 050034

  • Oncomedica S.A. ( Site 0406)

    Montería, Departamento de Córdoba, 230002

Other trials in Colombia

France6 sites

  • Groupe Hospitalier Pellegrin ( Site 0511)

    Bordeaux, Gironde, 33000

  • CHU Hopital Saint Antoine ( Site 0505)

    Paris, 75012

  • Hopital Bichat - Claude Bernard ( Site 0503)

    Paris, 75018

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

    Paris, Île-de-France Region, 75013

  • C.H.U. de Toulouse. Hopital de Purpan ( Site 0501)

    Toulouse, Midi-Pyrenees, 31059

  • Centre Hospitalier de Tourcoing ( Site 0502)

    Tourcoing, Nord, 59208

Other trials in France

Spain6 sites

  • Hospital Universitari Vall d Hebron ( Site 1305)

    Barcelona, Catalonia, 08035

  • Hospital Clinic ( Site 1304)

    Barcelona, 08036

  • Hospital Universitari Germans Trias i Pujol ( Site 1303)

    Barcelona, 08916

  • Hospital Universitario Gregorio Maranon ( Site 1302)

    Madrid, 28007

  • Hospital Universitario Ramon y Cajal ( Site 1301)

    Madrid, 28034

  • Hospital Universitario La Paz ( Site 1300)

    Madrid, 28046

Other trials in Spain

Brazil5 sites

  • Santa Casa de Misericordia de Belo Horizonte ( Site 0100)

    Belo Horizonte, Minas Gerais, 30150-221

  • Hospital Tacchini ( Site 0107)

    Bento Gonçalves, Rio Grande do Sul, 95700-000

  • Chronos Pesquisa Clínica ( Site 0105)

    Brasília, Federal District, 72145-424

  • Hospital de Clinicas da Universidade Federal do Parana ( Site 0104)

    Curitiba, Paraná, 80060-900

  • FUNFARME Hospital de Base Centro Integrado de Pesquisa ( Site 0101)

    São José do Rio Preto, São Paulo, 15090-000

Other trials in Brazil

Chile5 sites

  • Hospital Clinico Fusat ( Site 0300)

    Rancagua, Región del Libertador General Bernardo O’Higgins, 2820945

  • Clinica Universidad de los Andes ( Site 0301)

    Santiago, Region M. de Santiago, 2820945

  • Hospital Sotero del Rio [Santiago, Chile] ( Site 0304)

    Santiago, Region M. de Santiago, 8207257

  • Complejo Hospitalario San Jose ( Site 0306)

    Santiago, Region M. de Santiago, 8380419

  • Servicio de Salud Sur Hospital Lucio Cordova ( Site 0305)

    Santiago, Region M. de Santiago, 8900085

Other trials in Chile

Mexico4 sites

  • Hospital Civil de Guadalajara Fray Antonio Alcalde ( Site 0800)

    Guadalajara, Jalisco, 44280

  • Hospital Regional de Alta Especialidad del Bajio ( Site 0807)

    León, Guanajuato, 37660

  • Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran ( Site 0802)

    Mexico City, Mexico City, 14080

  • Hospital Universitario Dr. Jose Eleuterio Gonzalez ( Site 0803)

    Monterrey, Nuevo León, 64460

Other trials in Mexico

Poland4 sites

  • Centrum Medyczne w Lancucie Sp.zo.o. ( Site 1000)

    Łańcut, Podkarpackie Voivodeship, 37-100

  • Wojewodzki Szpital Specjalistyczny im. dr. Wladyslawa Bieganskiego ( Site 1001)

    Lodz-Baluty, Łódź Voivodeship, 91-347

  • Samodzielny Publiczny Szpital Kliniczny Nr 1 w Lublinie ( Site 1004)

    Lublin, Lublin Voivodeship, 20-081

  • Centrum Medyczne Pratia, Mazowiecki Szpital Specjalistyczny, Oddział Obserwacyjno - Zakaźny ( Site 1

    Ostrołęka, Masovian Voivodeship, 07-410

Other trials in Poland

South Africa4 sites

  • IATROS International ( Site 1202)

    Bloemfontein, Free State, 9301

  • TREAD Research ( Site 1201)

    Cape Town, Western Cape, 7500

  • Wits Baragwanath Clinical Trial Site ( Site 1204)

    Soweto, Gauteng, 2013

  • Clinical Projects Research Centre ( Site 1205)

    Worcester, Western Cape, 6850

Other trials in South Africa

Israel3 sites

  • Rambam Medical Center ( Site 2102)

    Haifa, 3525408

  • Hadassah Medical Center. Ein Kerem ( Site 2103)

    Jerusalem, 9112001

  • Chaim Sheba Medical Center ( Site 2100)

    Ramat Gan, 5265601

Other trials in Israel

South Korea3 sites

  • Chungnam National University Hospital ( Site 2202)

    Daejeon, Taejon-Kwangyokshi, 30515

  • Inha University Hospital ( Site 2204)

    Incheon, 22332

  • The Catholic University of Korea Eunpyeong St Mary s Hospital ( Site 2205)

    Seoul, 03312

Other trials in South Korea

United Kingdom3 sites

  • Royal Free London NHS Foundation Trust ( Site 1700)

    London, London, City of, NW3 2QG

  • King's College Hospital ( Site 1705)

    London, London, City of, SE5 9RS

  • North Manchester General Hospital ( Site 1701)

    Manchester, M8 5RB

Other trials in United Kingdom

Philippines2 sites

  • University of the Philippines-Philippine General Hospital ( Site 0900)

    Manila, National Capital Region, 1000

  • Lung Center of the Philippines ( Site 0902)

    Quezon City, National Capital Region, 1100

Other trials in Philippines

Canada1 site

  • University Health Network - Toronto General Hospital ( Site 0201)

    Toronto, Ontario, M5G 2N2

Other trials in Canada

Italy1 site

  • ASST Fatebenefratelli-Ospedale Sacco ( Site 0601)

    Milan, 20157

Other trials in Italy

About this study

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

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.

Read the 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.

Being tested
Molnupiravir, Placebo
Medical subject headings
COVID-19

What participants receive

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

  • MolnupiravirDrug

    Molnupiravir administered orally in capsule form every 12 hours for 5 days (10 doses total)

  • PlaceboDrug

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

Study groups in NCT04575584
Study groupRoleWhat they receive
Part 1: Molnupiravir 200 mgExperimental200 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)
Receives: Drug: Molnupiravir
Part 1: Molnupiravir 400 mgExperimental400 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)
Receives: Drug: Molnupiravir
Part 1: Molnupiravir 800 mgExperimental800 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)
Receives: Drug: Molnupiravir
Part 1: PlaceboPlacebo comparatorPlacebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total)
Receives: Drug: Placebo
Part 2: MolnupiravirExperimentalMolnupiravir (dose to be selected) administered orally every 12 hours for 5 days (10 doses total)
Receives: Drug: Molnupiravir
Part 2: PlaceboPlacebo comparatorPlacebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total)
Receives: Drug: Placebo

What is being measured

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

  1. 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.

    Measured: Up to 29 days

  2. 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.

    Measured: Up to 19 days (during treatment and 14-day follow-up)

  3. 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.

    Measured: Up to 5 days

Secondary outcomes (17)

  1. 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.

    Measured: Up to 29 days

  2. 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.

    Measured: Day 3

  3. Odds of a More Favorable Response on Pulmonary Ordinal Outcome Score on End of Treatment (EOT [Day 5])

    Pulmonary score is a score on an ordinal scale which focuses on respiratory sequalae based on oxygen requirements using 7 mutually exclusive categories. The score ranges from 1 ("can independently undertake personal usual activities with minimal or no symptoms") to 7 ("death") with a higher score indicating more severe respiratory sequalae. The number of participants at each score category is presented.

    Measured: EOT (Day 5)

  4. 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.

    Measured: Day 10

  5. 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.

    Measured: Day 15

  6. 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.

    Measured: Day 29

  7. 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.

    Measured: Day 3

  8. 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.

    Measured: EOT (Day 5)

  9. 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.

    Measured: Day 10

  10. Odds of a More Favorable Response on Pulmonary+ Ordinal Outcome Score on Day 15

    Pulmonary+ score is a score on an ordinal scale which is a 7-category assessment that captures the range of disease severity in hospitalized participants, including coagulation-related complications and respiratory dysfunction. The score ranges from 1 ("can independently undertake personal usual activities with minimal or no symptoms") to 7 ("death") with a higher score indicating more severe respiratory sequalae. The number of participants at each score category is presented.

    Measured: Day 15

  11. 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.

    Measured: Day 29

  12. 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.

    Measured: EOT (Day 5)

  13. 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.

    Measured: Day 3

  14. 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.

    Measured: EOT (Day 5)

  15. 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.

    Measured: Day 10

  16. 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.

    Measured: Day 15

  17. 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.

    Measured: Day 29

Timeline

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

  1. First posted5 Oct 2020
  2. Study start19 Oct 2020
  3. Primary completion11 Aug 2021
  4. Study completion11 Aug 2021

Why it stopped: Business reasons

Resources

More details

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

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
304 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04575584
Sponsor's protocol ID
4482-001
Other IDs
MK-4482-001, PHRR201210-003189, jRCT2031200404, 2020-003367-26
Status last verified
Jan 2023
First submitted
30 Sep 2020
Last updated
17 Jan 2023
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

Publications

  • Arribas JR, Bhagani S, Lobo SM, Khaertynova I, Mateu L, Fishchuk R, Park WY, Hussein K, Kim SW, Ghosn J, Brown ML, Zhang Y, Gao W, Assaid C, Grobler JA, Strizki J, Vesnesky M, Paschke A, Butterton JR, De Anda C. Randomized Trial of Molnupiravir or Placebo in Patients Hospitalized with Covid-19. NEJM Evid. 2022 Feb;1(2):EVIDoa2100044. doi: 10.1056/EVIDoa2100044. Epub 2021 Dec 16.

    PubMed 38319178

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Molnupiravir in people with Coronavirus Disease (COVID-19), run by Merck Sharp & Dohme LLC at 89 sites in 17 countries.

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

Who may be eligible to take part?

The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 17 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 89 sites in United States, Russia, Ukraine, Colombia, France and 12 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

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

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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

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

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Aug 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time-to-sustained Recovery (time frame: Up to 29 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04575584, which also lists 1 linked publication.

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

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

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2023.

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