NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCT2031210281

Registered date:27/08/2021

MK-4482 Phase 3 Study for Prevention of COVID-19 in Adults

Basic Information

Recruitment status Complete
Health condition(s) or Problem(s) studiedPreveintion of Coronavirus Disease (COVID-19)
Date of first enrollment15/01/2022
Target sample size1376
Countries of recruitmentUnited States,Japan,France,Japan,Hungary,Japan,Romania,Japan,Russia,Japan,South Africa,Japan,Spain,Japan,Turkey,Japan,Ukraine,Japan,Argentina,Japan,Brazil,Japan,Colombia,Japan,Guatemala,Japan,Mexico,Japan,Peru,Japan,Philippines,Japan,Thailand,Japan,Dominican Republic,Japan,Malaysia,Japan,Egypt,Japan,Kenya,Japan,Bulgaria,Japan
Study typeInterventional
Intervention(s)- Drug: Molnupiravir Participants take molnupiravir 800 mg (Four molnupiravir 200 mg capsules taken by mouth) every 12 hours (Q12H) on Days 1 to 5. - Drug: Placebo Participants take placebo (placebo capsule matched to molnupiravir 200 mg capsules taken by mouth) Q12H on Days 1 to 5.

Outcome(s)

Primary Outcome- Percentage of participants who have undetectable SARS-CoV-2 in baseline nasopharyngeal (NP) swabs and develop COVID-19 (laboratory-confirmed severe acute respiratory syndrome coronavirus 2 [SARS-CoV-2] infection with symptoms) through Day 14 [Time Frame: Up to Day 14] - Percentage of participants with >=1 adverse event [Time Frame: Up to 29 days] - Percentage of participants discontinuing from study therapy due to AE [Time Frame: Up to 5 days]
Secondary Outcome- Percentage of participants regardless of SARS-CoV-2 results in baseline NP swabs and develop COVID-19 (laboratory-confirmed SARS-CoV-2 infection with symptoms) on or before Day 14 [Time Frame: Up to Day 14] - Percentage of participants who have undetectable SARS-CoV-2 in baseline NP swabs and develop COVID-19 (laboratory-confirmed SARS-CoV-2 infection with symptoms) on or before Day 29 [Time Frame: Up to Day 29] - Percentage of participants who have undetectable SARS-CoV-2 in baseline NP swabs and develop detectable SARS-CoV-2 in NP swabs on or before Day 14 [Time Frame: Time of screening and Days 5 and 14] - Percentage of participants who have detectable SARS-CoV-2 in baseline NP swabs and develop COVID-19 (laboratory-confirmed SARS-CoV-2 infection with symptoms) on or before Day 14 [Time Frame: Up to Day 14]

Key inclusion & exclusion criteria

Age minimum>= 18age old
Age maximumNot applicable
GenderBoth
Include criteria- Lives in a household with an index case where the index case is a person with documented COVID-19 (laboratory-confirmed SARS-CoV-2 infection with symptoms case) and must have 1) a first positive SARS-CoV-2 test result from a sample collected within =<5 days prior to randomization of the participant, and 2) at least 1 symptom attributable to COVID-19 (e.g., fever, difficulty breathing) - Does not have confirmed or suspected COVID-19 - Is willing and able to take oral medication - Is male and willing to be abstinent from penile-vaginal intercourse or use a highly effective contraceptive method while receiving study drug and for >=3 months after the last dose of study intervention - Is female and not pregnant/breastfeeding and at least one of the following applies during the study and for >=4 days after: is not a woman of childbearing potential (WOCBP), is a WOCBP and uses highly effective contraception (low user dependency method OR a user dependent hormonal method in combination with a barrier method), or is a WOCBP who is abstinent from heterosexual intercourse
Exclude criteria- Has a prior history of laboratory-confirmed SARS-CoV-2 infection (with or without symptoms), within 6 months prior to randomization - Has human immunodeficiency virus (HIV) with a recent viral load >50 copies/mL (regardless of CD4 count) or an acquired immunodeficiency syndrome (AIDS)-defining illness in the past 6 months - Has a history of hepatitis B virus (HBV) or hepatitis C virus (HCV) infection with any of the following: cirrhosis, end-stage liver disease, hepatocellular carcinoma; aspartate transaminase (AST) and/or (ALT) >3x upper limit of normal at screening - 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 with conditions that could limit gastrointestinal absorption of capsule contents - Has received, is taking or is anticipated to require any prohibited therapies - Has received a COVID-19 vaccination with the first dose >=7 days prior to randomization - 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 - Is living in a household with >10 people

Related Information

Contact

Public contact
Name MSDJRCT inquiry mailbox
Address KITANOMARU SQUARE,1-13-12,Kudan-kita,Chiyoda-ku,Tokyo 102-8667,Japan Tokyo Japan 102-8667
Telephone +81-3-6272-1957
E-mail msdjrct@merck.com
Affiliation MSD K.K.
Scientific contact
Name Yoshiyuki Tanaka
Address KITANOMARU SQUARE,1-13-12,Kudan-kita,Chiyoda-ku,Tokyo 102-8667,Japan Tokyo Japan 102-8667
Telephone +81-3-6272-1957
E-mail msdjrct@merck.com
Affiliation MSD K.K.