Molnupiravir (MK-4482/EIDD-2801) Antiviral Clinical Trials .
MK-4482/EIDD-2801 is currently being tested in various, advanced multi-center clinical trials ;
Clinical Trial NCT04405739:
The Safety of Molnupiravir (EIDD-2801) and Its Effect on Viral Shedding of SARS-CoV-2 (END-COVID) - Last Update Posted: December 10, 2020.
Phase 2a randomized, placebo-controlled, double-blinded clinical trial of EIDD-2801 in adult men and women who have tested positive for severe acute respiratory syndrome-coronavirus-2 (SARS-CoV-2) infection within 48 hours of polymerase chain reaction (PCR) confirmation and are hospitalized with a diagnosis of COVID-19.
Rapid enrollment and treatment will be initiated such that the first dose of EIDD-2801 or placebo will be administered as soon as possible, and within 7 days of onset of symptoms.
Stratified randomization of participants will receive remdesivir at enrollment and those who will not receive remdesivir at enrollment.
Clinical Trial NCT04405570:
A Safety, Tolerability, and Efficacy of Molnupiravir (EIDD-2801) to Eliminate Infectious Virus Detection in Persons With COVID-19
This is a phase IIa, double-blind, placebo-controlled, randomized trial designed to compare the safety, tolerability, and antiviral activity of EIDD-2801 versus placebo as measured by infectious virus detection symptomatic adult outpatients with COVID-19.
The study is a multicenter trial that will be conducted in the United States.
In this study, up to approximately 108 participants will be randomized to receive EIDD-2801 or Placebo orally twice a day (BID) for 5 days. The study may enroll up to 5 parts with subsequent doses that may be higher or lower than doses studied in previous cohorts and will be doses that have been studied for safety in a Phase 1 study. Doses will be chosen based on emerging virology and safety data from this and ongoing studies.
Clinical Trial NCT04575584:
Efficacy and Safety of Molnupiravir (MK-4482) in Hospitalized Adult Participants With COVID-19 (MK-4482-001)
This study evaluates the safety, tolerability, and efficacy of molnupiravir (MK-4482) compared to placebo. The primary hypothesis is that molnupiravir is superior to placebo as assessed by the rate of sustained recovery through Day 29.
Clinical Trial NCT04575597:
Efficacy and Safety of Molnupiravir (MK-4482) in Non-Hospitalized Adult Participants With COVID-19 (MK-4482-002)
This study evaluates the safety, tolerability, and efficacy of molnupiravir (MK-4482) compared to placebo. The primary hypothesis is that molnupiravir is superior to placebo as assessed by the percentage of hospitalized and/or dead participants through Day 29.
