MK-4482 Study in Non-Hospitalised Adults with COVID-19 [COVID-19]
Research type
Research Study
Full title
A Phase 2/3, Randomized, Placebo-Controlled, Double-Blind Clinical Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of MK-4482 in Non-Hospitalized Adults with COVID-19
IRAS ID
288786
Contact name
Sanjay Bhagani
Contact email
Sponsor organisation
Merck Sharp & Dohme (UK) Limited
Eudract number
2020-003368-24
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 1 months, 30 days
Research summary
About the drug:
Standard of care treatment of COVID-19 is rapidly evolving and local treatment guidelines continue to be updated with emerging data. However,there remains a need for an effective oral antiviral treatment for COVID-19.MK-4482 (EIDD-2801) is an investigational antiviral agent currently in early clinical development for treatment of patients with COVID-19.
MK-4482 is an orally-administered prodrug of a small molecule nucleoside with broad-spectrum activity against a number of viruses, including beta-coronaviruses (SARS-CoV-2, SARS, and MERS).
MK-4482 is being studied in a single and multiple dose escalation study in humans. Because of the early stage of development, the human safety profile is not yet completely defined for MK-4482, however, based on review of
preliminary blinded safety data, MK-4482 has been generally well tolerated in healthy participants.About the study:
Around 1450 non-hospitalised participants ≥18 years of age with mild and moderate COVID-19 will be enrolled in this study. Participants with severe and critical COVID-19 are not eligible because they are expected to require hospitalisation. Each participant will be in the study for approximately 7 months from the time of provision of informed consent through to the final contact. Participants will be randomly assigned to MK-4482 or placebo (pills with no active drug). Treatment will be administered for 5 days (every 12 hours).Participants must meet certain criteria to be eligible, understand the possible risks and benefits of participation and provide informed consent. This trial will be taking place in about 14 countries worldwide in approximately 97 number
of sites. There will be 4 sites from the UK participating in this trial.About the drug company:
MSD and Ridgeback Biotherapeutics LP (hereafter, Ridgeback) are working together to develop this oral antiviral treatment for COVID-19. MSD will lead clinical development and manufacturing in collaboration with Ridgeback.REC name
London - London Bridge Research Ethics Committee
REC reference
20/HRA/4788
Date of REC Opinion
5 Oct 2020
REC opinion
Further Information Favourable Opinion