Home › Trials › NCT05568706

Treatment of RSV infection in high-risk adults with EDP-938

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

PHASE2 · Enanta Pharmaceuticals, Inc · NCT05568706

This study is testing a new oral medication called EDP-938 to see if it can help high-risk adults with RSV feel better and avoid serious complications.

Quick facts

PhasePHASE2
Study typeInterventional
Enrollment180 (estimated)
Ages18 Years and up
SexAll
SponsorEnanta Pharmaceuticals, Inc (industry)
Locations165 sites (Huntsville, Alabama and 164 other locations)
Trial IDNCT05568706 on ClinicalTrials.gov

What this trial studies

This Phase 2b clinical trial evaluates the efficacy of EDP-938, an oral medication, in treating non-hospitalized adults who have confirmed respiratory syncytial virus (RSV) infection and are at high risk for complications. Participants will be randomly assigned to receive either EDP-938 or a placebo in a double-blind manner. The study aims to assess the safety and effectiveness of the treatment in alleviating symptoms and preventing severe outcomes associated with RSV. Eligible participants must exhibit specific symptoms and have tested positive for RSV within a defined timeframe.

Who should consider this trial

Good fit: Ideal candidates include non-hospitalized adults aged 65 and older or those with conditions like congestive heart failure, asthma, or chronic obstructive pulmonary disease who have tested positive for RSV.

Not a fit: Patients who are not at high risk for complications from RSV infection or those who are hospitalized may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce complications and improve recovery outcomes for high-risk patients with RSV infection.

How similar studies have performed: Other studies have explored treatments for RSV, but the specific approach with EDP-938 in this high-risk population is novel.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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 this trial is running

Huntsville, Alabama and 164 other locations

+115 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: RSV Infection, High Risk, Respiratory Syncytial Virus

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.