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Trial - NCT04939428


Column Value
Trial registration number NCT04939428
Full text link
Last imported at : June 27, 2021, 2:30 a.m.
Source : ClinicalTrials.gov

First author
Last imported at : Nov. 2, 2022, midnight
Source : ClinicalTrials.gov

Not reported

Contact
Last imported at : Nov. 2, 2022, midnight
Source : ClinicalTrials.gov

Not reported

Registration date
Last imported at : June 27, 2021, 2:30 a.m.
Source : ClinicalTrials.gov

2021-06-25

Recruitment status
Last imported at : Dec. 11, 2022, 4 a.m.
Source : ClinicalTrials.gov

Completed

Study design
Last imported at : June 27, 2021, 2:30 a.m.
Source : ClinicalTrials.gov

RCT

Allocation
Last imported at : June 27, 2021, 2:30 a.m.
Source : ClinicalTrials.gov

Randomized

Design
Last imported at : June 27, 2021, 2:30 a.m.
Source : ClinicalTrials.gov

Parallel

Masking
Last imported at : June 27, 2021, 2:30 a.m.
Source : ClinicalTrials.gov

Blind label

Center
Last imported at : June 27, 2021, 2:30 a.m.
Source : ClinicalTrials.gov

multi-center

Study aim
Last imported at : June 27, 2021, 2:30 a.m.
Source : ClinicalTrials.gov

Prevention

Inclusion criteria
Last imported at : May 7, 2022, 5 a.m.
Source : ClinicalTrials.gov

inclusion 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 detectable 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 for males, agrees to be abstinent from penile-vaginal intercourse or agrees to use a highly effective contraceptive method while receiving study drug and for ≥3 months after the last dose of study drug 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

Exclusion criteria
Last imported at : Feb. 17, 2022, 5 p.m.
Source : ClinicalTrials.gov

has a prior history of laboratory-confirmed sars-cov-2 infection (with or without symptoms) within 6 months prior to randomization has either of the following: human immunodeficiency virus (hiv) with a recent viral load >50 copies/ml (regardless of cd4 count) or an acquired immunodeficiency syndrome (aids)-defining illness 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

Number of arms
Last imported at : June 27, 2021, 2:30 a.m.
Source : ClinicalTrials.gov

2

Funding
Last imported at : May 7, 2022, 5 a.m.
Source : ClinicalTrials.gov

Merck Sharp & Dohme LLC

Inclusion age min
Last imported at : June 27, 2021, 2:30 a.m.
Source : ClinicalTrials.gov

18

Inclusion age max
Last imported at : June 27, 2021, 2:30 a.m.
Source : ClinicalTrials.gov

100

Countries
Last imported at : July 23, 2022, 1:30 p.m.
Source : ClinicalTrials.gov

Argentina;Brazil;Bulgaria;Colombia;Dominican Republic;Egypt;France;Guatemala;Hungary;Japan;Kenya;Malaysia;Mexico;Peru;Philippines;Romania;Russia;South Africa;Spain;Thailand;Turkey;Ukraine;United States

Type of patients
Last imported at : June 27, 2021, 2:30 a.m.
Source : ClinicalTrials.gov

Close contacts to covid patients

Severity scale
Last imported at : June 27, 2021, 2:30 a.m.
Source : ClinicalTrials.gov

N/A

Total sample size
Last imported at : Feb. 8, 2024, 4 a.m.
Source : ClinicalTrials.gov

2441

primary outcome
Last imported at : Feb. 8, 2024, 4 a.m.
Source : ClinicalTrials.gov

Percentage of Participants Discontinuing From Study Therapy Due to AE;Percentage of Participants Who Had Undetectable SARS-CoV-2 in Baseline Nasopharyngeal (NP) Swabs and Developed COVID-19 (Laboratory-Confirmed SARS-CoV-2 Infection With Symptoms) Through Day 14;Percentage of Participants With ≥1 Adverse Event

Notes
Last imported at : June 27, 2021, 2:30 a.m.
Source : ClinicalTrials.gov

None

Phase
Last imported at : June 27, 2021, 2:30 a.m.
Source : ClinicalTrials.gov

Phase 3

Arms
Last imported at : June 27, 2021, 2:30 a.m.
Source : ClinicalTrials.gov

[{"arm_notes": "", "treatment_id": 813, "treatment_name": "Molnupiravir", "treatment_type": "Antivirals", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]