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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06667700




Registration number
NCT06667700
Ethics application status
Date submitted
30/10/2024
Date registered
31/10/2024

Titles & IDs
Public title
A Clinical Study of Molnupiravir to Prevent Severe Illness From Coronavirus Disease 2019 (COVID-19) in People Who Are High Risk (MK-4482-023)
Scientific title
A Phase 3, Randomized, Placebo-Controlled, Double-Blind Clinical Study to Evaluate the Efficacy and Safety of Molnupiravir (MK-4482) in Non-Hospitalized Adults With COVID-19 at High Risk for Disease Progression
Secondary ID [1] 0 0
2023-507227-36
Secondary ID [2] 0 0
4482-023
Universal Trial Number (UTN)
Trial acronym
MOVe-NOW
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Coronavirus Disease (COVID-19) 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Respiratory 0 0 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Molnupiravir
Treatment: Drugs - Placebo

Experimental: Molnupiravir - Participants will receive 800 mg molnupiravir orally every 12 hours for 5 days (a total of 10 consecutive doses)

Placebo comparator: Placebo - Participants will receive molnupiravir-matching placebo orally every 12 hours for 5 days (a total of 10 consecutive doses)


Treatment: Drugs: Molnupiravir
Molnupiravir administered orally as two 400 mg film-coated tablets every 12 hours for 5 days (a total of 10 consecutive doses)

Treatment: Drugs: Placebo
Molnupiravir-matching placebo administered orally as two film-coated tablets every 12 hours for 5 days (a total of 10 consecutive doses)
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants Who Experienced One or More of Following Through Day 29: All-cause Hospitalization, All-cause Mortality, or Covid-19-related Medically-attended Visit (MAV)
Timepoint [1] 0 0
Up to 29 days
Primary outcome [2] 0 0
Percentage of Participants Who Experience an Adverse Event (AE)
Timepoint [2] 0 0
Up to approximately 5 months
Primary outcome [3] 0 0
Percentage of Participants Who Discontinue Study Intervention Due to AE
Timepoint [3] 0 0
Up to approximately 5 days
Secondary outcome [1] 0 0
Time to Sustained Alleviation Without Relapse of All 8 Selected COVID-19-related Signs/Symptoms Through Day 29
Timepoint [1] 0 0
Up to 29 days
Secondary outcome [2] 0 0
Change from Baseline in Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Viral Load
Timepoint [2] 0 0
Day 1 (baseline) and up to Day 29
Secondary outcome [3] 0 0
Percentage of Participants with Undetectable SARS-CoV-2 Viral Load
Timepoint [3] 0 0
Up to 29 days
Secondary outcome [4] 0 0
Percentage of Participants Who Experienced One or More of Following Through Day 29: All-cause Hospitalization or All-cause Mortality
Timepoint [4] 0 0
Up to 29 days
Secondary outcome [5] 0 0
Percentage of Participants With Clinically Important Medical Interventions (CIMI) Associated with COVID-19-related MAV or COVID-19-related Hospitalization Through Day 29
Timepoint [5] 0 0
Up to 29 days
Secondary outcome [6] 0 0
Time to Sustained Alleviation Without Relapse of All 15 COVID-19-related Signs/Symptoms Through Day 29
Timepoint [6] 0 0
Up to 29 days
Secondary outcome [7] 0 0
Time to Sustained Resolution Without Relapse of All 8 Selected COVID-19-related Signs/Symptoms Through Day 29
Timepoint [7] 0 0
Up to 29 days

Eligibility
Key inclusion criteria
Inclusion Criteria

The main inclusion criteria include but are not limited to the following:

* Is an individual of any sex/gender, =18 years of age
* Has documentation of SARS-CoV-2 infection with sample collection =4 days prior to randomization
* Has initial onset of signs/symptoms attributable to COVID-19 for =4 days prior to the day of randomization and =2 of the following signs/symptoms attributable to COVID-19 on the day of randomization: cough, sore throat, nasal congestion, shortness of breath or difficulty breathing with exertion, muscle or body aches, fatigue, fever >38.0°C or chills, nausea or vomiting or diarrhea, change in sense of smell or change in sense of taste, or headache
* Has =1 of the following characteristics or medical conditions associated with the highest risk of severe illness from COVID-19:

* Advanced age of =75 years of age
* Immunocompromised
* Neurocognitive or physical disability
* Has =3 characteristics or medical conditions which increase the risk of severe illness due to COVID-19 (e.g., chronic lung disease, obesity with body mass index =35, diabetes)
* Is unable to receive treatment with nirmatrelvir/ritonavir (NMV/r) due to 1 or more of the following:

* Is receiving drug(s) highly dependent on cytochrome P450 3A (CYP3A) for clearance and for which elevated concentrations are associated with serious and/or life-threatening consequences or drug(s) with a clinically significant drug-drug interaction for which co-administration is not possible
* Is receiving potent CYP3A inducers where significantly reduced nirmatrelvir or ritonavir plasma concentrations may be associated with the potential for loss of virologic response and possible resistance
* Has severe renal or hepatic impairment
* Has experienced prior adverse reactions or hepatotoxicity to NMV/r that would preclude future use
* Has uncontrolled HIV infection
* Has known or suspected NMV/r resistance
* NMV/r is not approved/authorized in the participant's country or it is not accessible to participant (e.g., drug shortage)

Inclusion note: Participants may receive remdesivir as standard of care in addition to molnupiravir or placebo. If remdesivir is available and clinically appropriate per local clinical practice, investigators will aim to ensure that those who are most vulnerable to severe COVID-19 receive timely access to remdesivir as standard of care on this study.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria

The main exclusion criteria include but are not limited to the following:

* Is currently hospitalized or is expected to need hospitalization for COVID-19 imminently
* Has received or plans to receive SARS-CoV-2 directed antivirals or monoclonal antibodies for current episode of COVID-19 (other than study intervention and, if applicable, remdesivir as standard of care)
* Has =1 of the following signs/symptoms that are attributable to severe or critical COVID-19:

* Shortness of breath at rest
* Respiratory rate =30 breaths per minute
* Heart rate =125 beats per minute
* Peripheral oxygen saturation (SpO2) =93% on room air or on supplemental oxygen for a reason other than COVID-19 which has not increased since onset of COVID-19 signs/symptoms
* Is receiving >4 liters/minute supplemental oxygen for COVID-19 (but was not receiving supplemental oxygen prior to COVID-19), regardless of SpO2
* Has received a COVID-19 vaccine within 30 days prior to randomization
* Has a history of SARS-CoV-2 infection (with or without symptoms) within 30 days prior to randomization
* Has known or suspected hypersensitivity to active or inactive ingredients of molnupiravir

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
2/12/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
26/01/2031
Actual
Sample size
Target
3082
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Georgia
Country [6] 0 0
United States of America
State/province [6] 0 0
Idaho
Country [7] 0 0
United States of America
State/province [7] 0 0
Louisiana
Country [8] 0 0
United States of America
State/province [8] 0 0
Michigan
Country [9] 0 0
United States of America
State/province [9] 0 0
Mississippi
Country [10] 0 0
United States of America
State/province [10] 0 0
Nevada
Country [11] 0 0
United States of America
State/province [11] 0 0
North Carolina
Country [12] 0 0
United States of America
State/province [12] 0 0
Tennessee
Country [13] 0 0
United States of America
State/province [13] 0 0
Texas
Country [14] 0 0
United States of America
State/province [14] 0 0
Washington
Country [15] 0 0
New Zealand
State/province [15] 0 0
Auckland
Country [16] 0 0
Puerto Rico
State/province [16] 0 0
Humacao
Country [17] 0 0
Puerto Rico
State/province [17] 0 0
San Juan
Country [18] 0 0
Taiwan
State/province [18] 0 0
Kaohsiung

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Merck Sharp & Dohme LLC
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Medical Director
Address 0 0
Merck Sharp & Dohme LLC
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Toll Free Number
Address 0 0
Country 0 0
Phone 0 0
1-888-577-8839
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: http://engagezone.msd.com/ds_documentation.php


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06667700