NCT04405570

Safety, Tolerability and Efficacy of Molnupiravir (EIDD-2801) to Eliminate Infectious Virus Detection in Persons With COVID-19

A Phase IIa Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Safety, Tolerability and Efficacy of EIDD-2801 to Eliminate SARS-CoV-2RNA Detection in Persons With COVID-19

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 204 (actual)
• Sponsor: Ridgeback Biotherapeutics, LP · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This was a phase IIa, double-blind, placebo-controlled, randomized trial, designed to compare the safety, tolerability, and antiviral activity of EIDD-2801 (molnupiravir) versus placebo as measured by SARS-CoV-2 viral RNA detection in symptomatic adult outpatients with COVID-19.

Detailed description

This was a phase IIa, double-blind, placebo-controlled, randomized trial, designed to compare the safety, tolerability, and antiviral activity of molnupiravir versus placebo as measured by SARS-CoV-2 viral RNA detection in symptomatic adult outpatients with COVID-19. The study was a multicenter trial that was conducted in the United States. In this study, 204 participants were randomized and 202 received molnupiravir or placebo orally twice a day (BID) for 5 days. The study enrolled participants in 5 parts with each part evaluating molnupiravir doses of either 200 mg BID, 400 mg BID, or 800 mg BID. Doses were chosen based on emerging virology and safety data from this and ongoing studies. New dose groups were started after the selected dose had been studied for safety in a Phase 1 study.

Conditions

• SARS-CoV-2 Infection, COVID-19

Interventions

Type	Name	Description
DRUG	Molnupiravir 200 mg	Oral capsule of molnupiravir
DRUG	Molnupiravir 400 mg	Oral capsule of molnupiravir
DRUG	Molnupiravir 800 mg	Oral capsule of molnupiravir
DRUG	Placebo (PBO)	placebo oral capsule

Timeline

• Start date: 2020-06-19
• Primary completion: 2021-02-21
• Completion: 2021-02-21
• First posted: 2020-05-28
• Last updated: 2022-02-16
• Results posted: 2022-02-16

Locations

10 sites across 1 country: United States

Regulatory

• FDA-regulated drug study