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

  • STATUS
    Recruiting
  • participants needed
    70
  • sponsor
    Enanta Pharmaceuticals
Updated on 24 September 2021
fever
dyspnea
congestion
earache
influenza
cough
nasal congestion
wheezing
malaise
respiratory tract infection
nasal discharge
respiratory syncytial virus infection

Summary

This is 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.

Description

Subjects (aged 18 to 75 years, inclusive) with up to 48 hours of upper respiratory tract infection (URTI) symptoms who test 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) will be allowed in the study.

Approximately 70 subjects will be 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 will be approximately 2 weeks and will consist of 3 periods: Screening (occurs on Day1), Treatment (5 days), and Follow-up (9 days after last dose).

Details
Condition Respiratory syncytial virus, Respiratory Syncytial Virus (RSV) Infection
Treatment Placebo, EDP-938
Clinical Study IdentifierNCT04196101
SponsorEnanta Pharmaceuticals
Last Modified on24 September 2021

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