NCT04405739

The Safety of Molnupiravir (EIDD-2801) and Its Effect on Viral Shedding of SARS-CoV-2 (END-COVID)

The Safety of EIDD-2801 and Its Effect on Viral Shedding of SARS-CoV-2

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 71 (actual)
• Sponsor: Ridgeback Biotherapeutics, LP · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Designed as a multi-center, randomized, double-blind, placebo-controlled study to assess the efficacy and safety of EIDD-2801 on SARS-CoV-2 Virus Shedding in Newly Hospitalized Adults with polymerase chain reaction (PCR)-Confirmed COVID-19.

Detailed description

Phase 2a randomized, placebo-controlled, double-blinded clinical trial of EIDD-2801 (also known as MK 4482) in adult men and women who have tested positive for severe acute respiratory syndrome-coronavirus-2 (SARS-CoV-2) infection by polymerase chain reaction (PCR) test within 6 days (144 hours) prior to randomization 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.

Conditions

• SARS-CoV 2

Interventions

Type	Name	Description
DRUG	EIDD-2801	Oral capsule of EIDD-2801
DRUG	Placebo	Oral placebo capsule

Timeline

• Start date: 2020-06-16
• Primary completion: 2022-02-21
• Completion: 2022-02-21
• First posted: 2020-05-28
• Last updated: 2023-03-23
• Results posted: 2023-03-23

Locations

11 sites across 1 country: United States

Regulatory

• FDA-regulated drug study