Safety, Tolerability and Efficacy of Molnupiravir (EIDD-2801) to Eliminate Infectious Virus Detection in Persons With COVID-19
NCT04405570 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 204
Last updated 2022-02-16
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.
Conditions
- SARS-CoV-2 Infection, COVID-19
Interventions
- 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
Sponsors & Collaborators
- collaborator INDUSTRY
-
Ridgeback Biotherapeutics, LP
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-06-19
- Primary Completion
- 2021-02-21
- Completion
- 2021-02-21
- FDA Drug
- Yes
Countries
- United States
Study Locations
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