NCT04196101

A Study to Assess EDP-938 for the Treatment of Acute Upper Respiratory Tract Infection With Respiratory Syncytial Virus in Adult Subjects

A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Study of EDP-938 Administered Orally for the Treatment of Acute Upper Respiratory Tract Infection With Respiratory Syncytial Virus in Ambulatory Adult Subjects (RSVP)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 82 (actual)
• Sponsor: Enanta Pharmaceuticals, Inc · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This was a randomized, double-blind, placebo-controlled, multicentre, phase 2 study to evaluate the efficacy, safety and tolerability of orally administered EDP-938 in adults with RSV infection.

Detailed description

Subjects (aged 18 to 75 years, inclusive) with up to 48 hours of upper respiratory tract infection (URTI) symptoms who tested positive for respiratory syncytial virus (RSV) and negative for influenza virus by rapid testing (ie, Rapid Viral Screen). Subjects with stable asthma or chronic obstructive pulmonary disease (COPD) were allowed in the study. Eighty-two (82) subjects were enrolled in this Phase 2b, randomized, double-blind, placebo-controlled, multicentre study of EDP-938 administered orally for the treatment of acute URTI with confirmed RSV infection in ambulatory adult subjects. For each subject, the duration of study participation was approximately 2 weeks and consisted of 3 periods: Screening (occurs on Day1), Treatment (5 days), and Follow-up (9 days after last dose).

Conditions

• Respiratory Syncytial Virus

Interventions

Type	Name	Description
DRUG	EDP-938	Four tablets daily for 5 days
DRUG	Placebo	Four tablets daily for 5 days

Timeline

• Start date: 2020-01-22
• Primary completion: 2022-01-04
• Completion: 2022-01-04
• First posted: 2019-12-12
• Last updated: 2023-10-30
• Results posted: 2023-10-30

Locations

29 sites across 7 countries: United States, Argentina, Bulgaria, New Zealand, Poland, South Africa, Ukraine

Regulatory

• FDA-regulated drug study