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Submitted by: Gladys Joy Martinez 2020-12-07 04:59:12 Last Updated by: Gladys Joy Martinez 2021-04-07 15:22:56


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

PHRR201209-003186

MK-4482-002; CT.gov NCT04575597

2020-CT0569

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

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

Start Date Duration in Months Target Completion Date Actual Completion Date
2021-04-15 12 2022-04-15 2022-02-28

Ongoing

Institution Classification Region LTO #
Merck Sharp & Dohme (I.A.) LLC Private Business NCR LTO-3000006624320
Institution Classification Region LTO #
Merck Sharp & Dohme (I.A.) LLC Private Business NCR LTO-3000006624320
Institution Region
Merck Sharp & Dohme (I.A.) LLC NCR
Name E-Mail Institution and Institution Address
Priscila D. Perez priscila.d.perez@merck.com Merck Sharp & Dohme (I.A.) LLC, 26/F Philamlife Tower, 8767 Paseo De Roxas, Makati, Metro Manila
Name E-Mail Institution and Institution Address
Priscila D. Perez priscila.d.perez@merck.com Merck Sharp & Dohme (I.A.) LLC, 26/F Philamlife Tower, 8767 Paseo De Roxas, Makati, Metro Manila
Name Expertise Affiliation
Virgina de los Reyes, MD Infectious Disease Lung Center of the Philippines
Project Location Institutional Ethics Review Board
Lung Center of the Philippines Lung Center of the Philippines Ethics Review Committee

Coronavirus Disease (COVID-19)

1. Percentage of participants who are hospitalized and/or die [ Time Frame: Up to 29 days ]
Hospitalization (all cause) is ≥24 hours of acute care in a hospital or similar acute care facility. Death is due to any cause.
 
2. Percentage of participants with an adverse event (AE) [ Time Frame: Up to ~7 months ]
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.
 
3. Percentage of participants who discontinued study intervention due to an AE [ Time Frame: Up to 6 days ]
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.

1. Time to improvement or resolution of targeted COVID-19 signs/symptoms [ Time Frame: Up to 29 days ]
The number of days from randomization to the first day on or before study Day 29 by which the targeted self-reported signs/symptoms improve or resolve.

2. Time to progression of targeted COVID-19 signs/symptoms [ Time Frame: Up to 29 days ]
The number of days from randomization to the first day on or before study Day 29 by which the targeted self-reported signs/symptoms are newly reported or worsen.

3.WHO 11-point outcomes score on a scale [ Time Frame: Up to 29 days ]
The World Health Organization (WHO) outcome scale is an 11-point ordinal score that categorizes clinical progression. Score ranges from 0 to 10 with higher score indicating clinical progression.

Recruiting

  • Brazil
  • Canada
  • Chile
  • Colombia
  • France
  • Germany
  • Israel
  • Italy
  • Mexico
  • Philippines
  • Russia
  • South Africa
  • Spain
  • Sweden
  • Ukraine
  • United Kingdom
  • United States

Clinical Trial

MK-4482-002; CT.gov NCT04575597

20201001071746

2020-11-04

0000-00-00

15

Unspecified

NA

15 Apr 2021

Key Inclusion Criteria:

-Has documentation of polymerase chain reaction (PCR)-confirmed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection with sample collection ≤7 days prior to 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.

-Has initial onset of signs/symptoms attributable to COVID-19 for ≤7 days prior to randomization and at least 1 sign/symptom attributable to COVID-19 on the day of randomization

-Has mild or moderate COVID-19. Participants with mild COVID-19 must have 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 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) during the intervention period and for at least 7 months 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.

 

Key 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 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 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.

-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 study through Day 29 with an investigational compound or device, including those for COVID-19 therapeutics

-Has a baseline heart rate of < 50 beats per minute at rest

-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 not associated with COVID-19, or participants with conditions that could limit gastrointestinal absorption of capsule contents.

Interventional

Molnupiravir and Placebo

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

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

Date Amendment Classification Reason
2021-02-11 Amendments related to the protocol Document Tracking Number: 20210126084239. To revise the dose selection process before initiation of Part 2 (Phase 3), update the benefit/risk assessment, clarify the key secondary efficacy objective regarding COVID-19 signs/symptoms, and add a discontinuation criterion.

Randomized

Double Blind

Double: (Participant, Investigator)

Parallel

The trial is currently ongoing; therefore results are not currently available.

Phase II/III

Utilization Utilization Info
No records found.
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