Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at Fresno, California and other locations
Dates
study started
completion around

Description

Summary

This is a Phase 2b, randomized, double-blind, placebo-controlled study of EDP-938 administered orally for the treatment of non-hospitalized adult subjects with confirmed RSV infection who are at high risk for complications after RSV infection.

Official Title

A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of EDP-938 in Non-hospitalized Adults with Acute Respiratory Syncytial Virus Infection Who Are At High Risk for Complications

Keywords

RSV Infection, High Risk, Respiratory Syncytial Virus, Infections, Respiratory Syncytial Virus Infections, EDP-938

Eligibility

You can join if…

Open to people ages 18 years and up

  • At least one of the following conditions that predispose them to complications after

    RSV infection:

    1. Age ≥65 years
    2. Congestive heart failure (CHF)
    3. Asthma
    4. Chronic obstructive pulmonary disease (COPD)
  • The subject has a new onset of any of the following symptom(s) or worsening of pre-existing symptom(s) consistent with a respiratory tract infection no more than 72 hours prior to the administration of the first dose of study drug: feeling feverish, headache, neck pain, fatigue, loss of appetite, interrupted sleep, body aches, sore throat, nasal congestion, cough, cough with phlegm, wheezing, or short of breath.
  • The subject reports at least 2 of the following symptoms, one of which must be reported as at least 'moderate' severity: cough, cough with phlegm, wheezing, or short of breath
  • The subject has tested positive for RSV infection using a NAAT (polymerase chain reaction [PCR] or other) on a nasal/nasopharyngeal swab sample.
  • A woman of childbearing potential who is sexually active with a male must agree to use two effective methods of contraception from the date of Screening until 30 days after her last dose of study drug.
  • A male subject who has not had a vasectomy and is sexually active with a woman of childbearing potential must agree to use effective contraception from the date of Screening to 90 days after his last dose of study drug.

You CAN'T join if...

  • The subject has an anticipated need for hospitalization within 24 hours of signing the Study ICF
  • The subject receives systemic antiviral, antibacterial, antifungal, or antimycobacterial therapy within 7 days prior to signing the Study ICF
  • The subject has concomitant respiratory infections that are viral (other than RSV but including influenza), bacterial, or fungal, including systemic bacterial or fungal infections, within 7 days prior to signing the Study ICF
  • The subject has a SARS-CoV-2 test result that is positive within 28 days prior to signing the Study ICF
  • The subject has COPD with spirometry results (obtained within 1 year prior to signing the Study ICF) FEV1 ≤35%
  • The subject has a known positive human immunodeficiency virus infection, active hepatitis A virus infection, chronic hepatitis B virus infection, and/or current hepatitis C virus (HCV) infection; subjects with a history of HCV infection who have achieved a documented sustained virologic response 12 weeks after completion of HCV therapy may be enrolled.
  • The subject has any of the following cardiac conditions: any congenital heart disease, congenital long QT syndrome, or any clinical manifestation resulting in QT interval prolongation
  • The subject has immunocompromised status
  • The subject is living in institutional care or assisted living facility and is also receiving acute care management for any respiratory condition; Note: Independent living apartments are not considered institutional care or assisted living facility

Locations

  • UCSF Fresno accepting new patients
    Fresno California 93701 United States
  • Capitis Medical And Aesthetics withdrawn
    Roseville California 95678-2474 United States
  • Downtown LA Research Center Inc - ClinEdge - PPDS accepting new patients
    Los Angeles California 90017 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Enanta Pharmaceuticals, Inc
ID
NCT05568706
Phase
Phase 2 RSV Research Study
Study Type
Interventional
Participants
Expecting 180 study participants
Last Updated