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Rolling review of MK 4482 for COVID-19 begins in Canada.

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Published:15th Aug 2021
Phase II interim results from the Phase II/III MOVe-OUT clinical trials were presented at the European Congress of Clinical Microbiology & Infectious Diseases (ECCMID) in July.

Phase III of the trial, evaluating molnupiravir twice daily for five days in non-hospitalized adults with confirmed SARS-CoV-2, five days or less following symptom onset and at least one risk factor associated with poor disease outcomes, is underway and includes sites in Canada.

MOVe-OUT (MK-4482-002) is a Phase II/III, randomized, placebo-controlled, double-blind, multi-site study evaluating orally administered molnupiravir in non-hospitalized participants at least 18 years of age with laboratory confirmed COVID-19 and symptom onset within five days prior to randomization. The trial plans to enroll a total of 1,850 participants with mild or moderate COVID-19. A total of 1,550 patients in the Phase III portion of the trial will be randomized 1:1 to receive either molnupiravir (800 mg) or placebo twice daily for five days. The primary efficacy objective is to evaluate efficacy of molnupiravir compared to placebo as assessed by the percentage of participants who are hospitalized and/or die during the period from randomization through Day 29.

Merck Inc., announced the initiation of a rolling submission to Health Canada for MK 4482 (molnupiravir), an investigational twice daily oral antiviral agent currently in trials as a potential treatment for COVID-19. Merck is developing molnupiravir in collaboration with Ridgeback Biotherapeutics.

Condition: Coronavirus/COVID-19 Infection
Type: drug

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