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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
Date last updated
14/07/2025
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)
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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
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Secondary ID [1]
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2023-507227-36-00
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Secondary ID [2]
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4482-023
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Universal Trial Number (UTN)
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Trial acronym
MOVe-NOW
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Coronavirus Disease (COVID-19)
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Condition category
Condition code
Infection
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Other infectious diseases
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Respiratory
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Other respiratory disorders / diseases
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Intervention/exposure
Study type
Interventional
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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)
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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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)
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Assessment method [1]
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Hospitalization is defined as =24 hours of acute care in a hospital or similar acute care facility, including emergency rooms or facilities created to address hospitalization needs specifically for COVID-19. Hospitalization and death may be due to any cause. An MAV is defined as any unscheduled, nonroutine healthcare visit where the participant is evaluated by a licensed (according to local/national guidelines) healthcare provider. As prespecified by the protocol, the percentage of participants who experience ONE OR MORE of these 3 events (hospitalization, death, or COVID-19-related MAV) occurring from randomization through Day 29 will be presented.
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Timepoint [1]
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Up to 29 days
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Primary outcome [2]
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Percentage of Participants Who Experience an Adverse Event (AE)
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Assessment method [2]
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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. The percentage of participants with at least 1 AE will be presented.
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Timepoint [2]
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Up to approximately 5 months
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Primary outcome [3]
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Percentage of Participants Who Discontinue Study Intervention Due to AE
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Assessment method [3]
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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. The percentage of participants who discontinue study intervention due to an AE will be presented.
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Timepoint [3]
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Up to approximately 5 days
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Secondary outcome [1]
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Time to Sustained Alleviation Without Relapse of All 8 Selected COVID-19-related Signs/Symptoms Through Day 29
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Assessment method [1]
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Time to sustained alleviation without relapse is defined as the number of days from randomization to the first of 2 consecutive days when alleviation (lessening of symptoms) is demonstrated, collectively, for all 8 selected COVID-19-related sign/symptoms. Participants who experience sustained alleviation for 2 consecutive days must not relapse in any of the 8 signs/symptoms before Day 29. The time to sustained alleviation without relapse of all 8 selected COVID-19-related signs/symptoms from randomization through Day 29 will be presented.
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Timepoint [1]
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Up to 29 days
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Secondary outcome [2]
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Change from Baseline in Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Viral Load
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Assessment method [2]
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SARS-CoV-2 RNA titer (viral load) will be measured by quantitative reverse transcriptase polymerase chain reaction (RT-PCR) of samples from nasopharyngeal (NP) swabs, and the mean change from baseline will be presented.
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Timepoint [2]
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Day 1 (baseline) and up to Day 29
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Secondary outcome [3]
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Percentage of Participants with Undetectable SARS-CoV-2 Viral Load
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Assessment method [3]
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SARS-CoV-2 RNA (viral load) will be measured by quantitative RT-PCR of samples from NP swabs, and the percentage of participants with undetectable (i.e., below the lower limit of quantification) SARS-CoV-2 RNA (viral load) will be presented.
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Timepoint [3]
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Up to 29 days
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Secondary outcome [4]
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Percentage of Participants Who Experienced One or More of Following Through Day 29: All-cause Hospitalization or All-cause Mortality
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Assessment method [4]
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Hospitalization is defined as =24 hours of acute care in a hospital or similar acute care facility, including emergency rooms or facilities created to address hospitalization needs specifically for COVID-19. Hospitalization and death may be due to any cause. As prespecified by the protocol, the percentage of participants who experience hospitalization AND/OR death occurring from randomization through Day 29 will be presented.
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Timepoint [4]
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Up to 29 days
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Secondary outcome [5]
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Percentage of Participants With Clinically Important Medical Interventions (CIMI) Associated with COVID-19-related MAV or COVID-19-related Hospitalization Through Day 29
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Assessment method [5]
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CIMIs were prespecified by the protocol and include, but are not limited to, supplemental oxygen therapy, IV fluid administration, and nebulizer treatment. An MAV is defined as any unscheduled, nonroutine healthcare visit where the participant is evaluated by a licensed (according to local/national guidelines) healthcare provider. Hospitalization is defined as =24 hours of acute care in a hospital or similar acute care facility, including emergency rooms or facilities created to address hospitalization needs specifically for COVID-19. The percentage of participants with CIMIs associated with a COVID-19-related MAV AND/OR a COVID-19-related hospitalization through Day 29 will be reported.
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Timepoint [5]
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Up to 29 days
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Secondary outcome [6]
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Time to Sustained Alleviation Without Relapse of All 15 COVID-19-related Signs/Symptoms Through Day 29
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Assessment method [6]
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Time to sustained alleviation without relapse is defined as the number of days from randomization to the first of 2 consecutive days when alleviation (lessening of symptoms) is demonstrated, collectively, for all 15 COVID-19-related sign/symptoms. Participants who experience sustained alleviation after 2 consecutive days must not relapse in any of the 15 signs/symptoms before Day 29. The time to sustained alleviation without relapse of all 15 COVID-19-related signs/symptoms from randomization through Day 29 will be presented.
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Timepoint [6]
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Up to 29 days
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Secondary outcome [7]
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Time to Sustained Resolution Without Relapse of All 8 Selected COVID-19-related Signs/Symptoms Through Day 29
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Assessment method [7]
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Time to sustained resolution without relapse is defined as the number of days from randomization to the first of 2 consecutive days when resolution (having no symptoms or only mild symptoms) is demonstrated, collectively, for all 8 selected COVID-19-related sign/symptoms. Participants who experience sustained resolution after 2 consecutive days must not relapse in any of the 8 signs/symptoms before Day 29. The time to sustained resolution without relapse of all 8 selected COVID-19-related signs/symptoms from randomization through Day 29 will be presented.
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Timepoint [7]
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Up to 29 days
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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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
2/12/2024
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
26/01/2031
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Actual
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Sample size
Target
3082
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Accrual to date
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Final
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Recruitment in Australia
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Recruitment outside Australia
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Krung Thep Maha Nakhon
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Country [97]
0
0
Ukraine
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State/province [97]
0
0
Cherkaska Oblast
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Country [98]
0
0
Ukraine
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State/province [98]
0
0
Chernihivska Oblast
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Country [99]
0
0
Ukraine
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State/province [99]
0
0
Ivano-Frankivska Oblast
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Country [100]
0
0
Ukraine
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State/province [100]
0
0
Kirovohradska Oblast
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Country [101]
0
0
Ukraine
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State/province [101]
0
0
Kyivska Oblast
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Country [102]
0
0
Ukraine
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State/province [102]
0
0
Lvivska Oblast
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Country [103]
0
0
Ukraine
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State/province [103]
0
0
Volynska Oblast
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Country [104]
0
0
Ukraine
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State/province [104]
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Kyiv
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Country [105]
0
0
United Kingdom
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State/province [105]
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0
Bristol, City Of
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Country [106]
0
0
United Kingdom
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State/province [106]
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0
England
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Country [107]
0
0
United Kingdom
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State/province [107]
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0
Newcastle Upon Tyne
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Country [108]
0
0
United Kingdom
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State/province [108]
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0
Oxfordshire
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Country [109]
0
0
United Kingdom
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State/province [109]
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0
Northamptonshire
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Merck Sharp & Dohme LLC
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
Researchers are looking for other ways to prevent severe illness from COVID-19. COVID-19 is a virus that most often causes mild flu or cold-like symptoms. However, people with certain health conditions or other factors have a high risk (chance) of getting severely ill from COVID-19, which can require a hospital stay or lead to death. Some people who are high risk for severe illness may be unable to take certain treatments for COVID-19 because they are not available to them, or they take other medicines that may react with a treatment and cause an unwanted effect. Molnupiravir (MK-4482) is a study medicine designed to stop the COVID-19 virus from copying itself in the body (multiplying). The goal of this study is to learn if molnupiravir prevents severe illness from COVID-19 more than placebo in people who are high risk.
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Trial website
https://clinicaltrials.gov/study/NCT06667700
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Medical Director
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Address
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Merck Sharp & Dohme LLC
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Country
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0
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Phone
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0
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Fax
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0
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Email
0
0
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Contact person for public queries
Name
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0
Toll Free Number
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Address
0
0
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0
0
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Phone
0
0
1-888-577-8839
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Fax
0
0
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Email
0
0
[email protected]
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Contact person for scientific queries
Data sharing statement
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
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