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

COMPLETEDPHASE2

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

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

NCT05568706•Enanta Pharmaceuticals, Inc

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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

Locations (84)

Voyage Medical

Tempe, Arizona, United States

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

Key Dates

Start Date

November 29, 2022

Primary Completion Date

June 23, 2025

Completion Date

June 23, 2025

Last Updated

July 1, 2025

Enrollment

186

ACTUAL participants

Conditions

RSV Infection

Interventions

EDP-938

DRUG

Placebo

DRUG

Evaluating the Infectivity, Safety and Immunogenicity of Respiratory Syncytial Virus Vaccines, RSV 6120/∆NS1 and RSV 6120/F1/G2/∆NS1, in RSV-Seropositive Children and RSV-Seronegative Infants and Children

NCT03596801

RSV Infection

View study

COMPLETEDPHASE1

Study to Evaluate the Safety and Immune Response of an Investigational Vaccine for the Prevention of RSV (Respiratory Syncytial Virus) and (hMPV) Human Metapneumovirus Infection in Participants Aged 60 to 75 Years

NCT06583031

RSV InfectionhMPV

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 1, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Evaluating the Infectivity, Safety and Immunogenicity of Respiratory Syncytial Virus Vaccines, RSV 6120/∆NS1 and RSV 6120/F1/G2/∆NS1, in RSV-Seropositive Children and RSV-Seronegative Infants and Children

Study to Evaluate the Safety and Immune Response of an Investigational Vaccine for the Prevention of RSV (Respiratory Syncytial Virus) and (hMPV) Human Metapneumovirus Infection in Participants Aged 60 to 75 Years

Evaluating the Infectivity, Safety and Immunogenicity of a Recombinant Live-Attenuated Respiratory Syncytial Virus Vaccine, LID/ΔM2-2/1030s, in RSV-Seronegative Infants and Children 6 to 24 Months of Age

Study of Obeldesivir to Treat Nonhospitalized Adults With Acute Respiratory Syncytial Virus (RSV) Infection

A Study to Evaluate the Drug-Drug Interaction of EDP-323 With Midazolam, Caffeine, and Rosuvastatin in Healthy Participants

Evaluation of the Labcorp COVID-19+Flu+RSV Test Home Collection Kit