A Study of EDP-938 in Non-hospitalized Adults With RSV Who Are at High Risk for Complications.

Completed · Phase 2 · Has a placebo group

Conditions studied: RSV Infection

In brief

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.

Key facts

Study ID

NCT05568706

Run by

Enanta Pharmaceuticals, Inc

People needed

186

Starts

2022-11-29

Expected to finish

2025-06-23

Last updated by the study team

2025-07-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• At least one of the following conditions that predispose them to complications after RSV infection:
• Age ≥65 years
• Congestive heart failure (CHF)
• Asthma
• 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 may not qualify 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

Where it is running

• UCSF Fresno — Fresno, California, United States
• Torrance Clinical Research Institute — Lomita, California, United States
• Downtown LA Research Center Inc - ClinEdge - PPDS — Los Angeles, California, United States
• Allianz Research Institute Inc — Westminster, California, United States
• Allianz Research Institute - Colorado — Aurora, Colorado, United States
• Bay Pines VA Healthcare System — Bay Pines, Florida, United States
• C&A Clinical Trials Corp — Cape Coral, Florida, United States
• Beautiful Minds Clinical Research Center — Cutler Bay, Florida, United States
• Dinamo Research & Diagnostic center, LLC — Hialeah, Florida, United States
• I.H.S Health LLC — Kissimmee, Florida, United States
• Dynamic Medical Research, LLC — Miami, Florida, United States
• Floridian Research Institute — Miami, Florida, United States
• Orlando VA Healthcare System — Orlando, Florida, United States
• Ormond Beach Clinical Research — Ormond Beach, Florida, United States
• CDC Research Institute, LLC — Port Saint Lucie, Florida, United States
• Research Bay, Inc. — Tampa, Florida, United States
• Santos Research Center — Tampa, Florida, United States
• Covenant Pulmonary Criticial Care and Research Ins — East Point, Georgia, United States
• Snake River Research — Idaho Falls, Idaho, United States
• University of Louisville — Louisville, Kentucky, United States
• Mercury Street Medical — Butte, Montana, United States
• Global Health Institute — Syracuse, New York, United States
• Progressive Medicine of the Triad, LLC — Winston-Salem, North Carolina, United States
• Toledo Institute of Clinical Research — Toledo, Ohio, United States
• Voyage Medical — Tempe, Arizona, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.