A Phase 2/3 Randomized, Placebo-Controlled, Double-Blind Clinical Study to Evaluate the Efficacy, Safety and Pharmacokinetics of MK-4482 in Hospitalized Participants ≥18 Years of Age with COVID-19

About this Study

This study seeks to evaluate the efficacy, tolerability, and safety of MK-4482 (a novel ribonucleoside analog prodrug with broad-spectrum antiviral activity against a range of RNA viruses)..

Sponsor Protocol ID:001-00
IRB Number:pending
Actively Enrolling
Interventional
Phase 2
September 08, 2020
Eligibility Criteria
18 years old
Both Male and Female
No
No
No

Inclusion Criteria1. Has active SARS-CoV-2 infection

2. Requires inpatient hospital medical care for ongoing clinical manifestations of COVID-19 (not just for public health or quarantine purposes).

3.  ≥18 years of age, at the time of signing the informed consent.


Exclusion Criteria
1. Has critical COVID-19 with any of the following:
• Respiratory failure as defined in Appendix 9
• Shock (defined by systolic blood pressure
• Multi-organ dysfunction/failure

2. 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 who are not expected to survive longer than 24 hours after randomization, participants with a recent history of mechanical ventilation not associated with COVID-19, or participants with conditions that could limit gastrointestinal absorption of capsule contents.

Categories Click category to view its trials.
COVID-19 (Coronavirus)
Participating Locations
University Hospital
Contact Information
Contact Name: Jamie Brown
Phone Number: 601-496-7815
Email: jlbrown@umc.edu
Principal Investigator:Nandi, Utsav, M.D.
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