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

NCT05568706 | Completed Phase 2 FDA Drug

• 1 other identifier: EDP 938-104
• Study Type: interventional
• Target: 186
• Locations: 12 countries
• Sites: 84

Brief 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.

Conditions

RSV Infection

Keywords

High Risk, Respiratory Syncytial Virus

Outcome Measures

Primary Outcomes (1)

• Time to resolution of RSV Lower Respiratory Tract Disease (LRTD) symptoms

  Day 1 through Day 33

Secondary Outcomes (18)

• Time to resolution of LRTD symptoms and 2 systemic symptoms

  Day 1 through Day 33

• Time to resolution of all RSV symptoms

  Day 1 through Day 33

• Change from Baseline in severity of RSV LRTD symptoms

  Day 1 through Day 33

• Change from Baseline for impact scale

  Day 1 through Day 33

• Time to resolution of Upper Respiratory Tract Disease congestion), LRTD, and 2 systemic symptoms

  Day 1 through Day 33

Study Arms (2)

EDP-938

EXPERIMENTAL

EDP-938 800 mg, once daily

Drug: EDP-938

Placebo

PLACEBO COMPARATOR

Matching placebo, once daily

Drug: Placebo

Interventions

EDP-938 DRUG

Subjects will take EDP-938 once daily for 5 days

EDP-938

Placebo DRUG

Subjects will take matching placebo, once daily for 5 days

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Enanta Pharmaceuticals, Inc: lead

Study Sites (84)

Voyage Medical

Tempe, Arizona, 85282-2455, United States

Location

UCSF Fresno

Fresno, California, 93701, United States

Location

Torrance Clinical Research Institute

Lomita, California, 90717, United States

Location

Downtown LA Research Center Inc - ClinEdge - PPDS

Los Angeles, California, 90017, United States

Location

Allianz Research Institute Inc

Westminster, California, 92683, United States

Location

Allianz Research Institute - Colorado

Aurora, Colorado, 80014, United States

Location

Bay Pines VA Healthcare System

Bay Pines, Florida, 33744, United States

Location

C&A Clinical Trials Corp

Cape Coral, Florida, 33990, United States

Location

Beautiful Minds Clinical Research Center

Cutler Bay, Florida, 33157, United States

Location

Dinamo Research & Diagnostic center, LLC

Hialeah, Florida, 33015, United States

Location

I.H.S Health LLC

Kissimmee, Florida, 34741, United States

Location

Dynamic Medical Research, LLC

Miami, Florida, 33144, United States

Location

Floridian Research Institute

Miami, Florida, 33179-2537, United States

Location

Orlando VA Healthcare System

Orlando, Florida, 32827, United States

Location

Ormond Beach Clinical Research

Ormond Beach, Florida, 32174, United States

Location

CDC Research Institute, LLC

Port Saint Lucie, Florida, 34952, United States

Location

Research Bay, Inc.

Tampa, Florida, 33607, United States

Location

Santos Research Center

Tampa, Florida, 33615, United States

Location

Covenant Pulmonary Criticial Care and Research Ins

East Point, Georgia, 30344, United States

Location

Snake River Research

Idaho Falls, Idaho, 83404, United States

Location

University of Louisville

Louisville, Kentucky, 40202, United States

Location

Mercury Street Medical

Butte, Montana, 59701, United States

Location

Global Health Institute

Syracuse, New York, 13210-1685, United States

Location

Progressive Medicine of the Triad, LLC

Winston-Salem, North Carolina, 27103, United States

Location

Toledo Institute of Clinical Research

Toledo, Ohio, 43617, United States

Location

IMA Clinical Research - Austin - PPDS

Austin, Texas, 78704-7507, United States

Location

Valley Institute of Research

Fort Worth, Texas, 76164-9041, United States

Location

HDH Research, Inc.

Houston, Texas, 77022, United States

Location

Metroplex Pulmonary and Sleep Medicine Center-4833 Medical Center Dr Unit 6B

McKinney, Texas, 75069, United States

Location

SMS Clinical Research, LLC

Mesquite, Texas, 75149, United States

Location

Eastside Research Associates

Redmond, Washington, 98052, United States

Location

Instituto Medico Platense

La Plata, Buenos Aires, 1900, Argentina

Location

Centro de Investigaciones Medica Mar del Plata

Mar del Plata, Buenos Aires, B7600FYK, Argentina

Location

Clinica Privada Independencia

Munro, Buenos Aires, B1605, Argentina

Location

Consultorios Médicos Dr. Doreski

Buenos Aires, Ciudad Autónoma de BuenosAires, C1426ABP, Argentina

Location

Instituto Médico Río Cuarto

Río Cuarto, Córdoba Province, 5800, Argentina

Location

Instituto Del Buen Aire

Santa Fe, Santa Fe Province, 3000, Argentina

Location

Clinica Mayo de U.M.C.B. S.R.L

San Miguel de Tucumán, Tucumán Province, T4000NWB, Argentina

Location

Multiprofile Hospital for Active Treatment Puls AD - PPDS

Blagoevgrad, Blagoevgrad, 2700, Bulgaria

Location

Medical Center For Life EOOD

Burgas, Burgas, 8000, Bulgaria

Location

Diagnostic Consultative Center-1-Sevlievo EOOD

Sevlievo, Gabrovo, 5400, Bulgaria

Location

Medical Center Zdrave-1 OOD

Kozloduy, Kozloduy, 3320, Bulgaria

Location

Medical Center Hera - Kyustendil EOOD

Kyustendil, Kyustendil, 2500, Bulgaria

Location

Specialized Hospital for Active Treatment of Pulmonary Diseases

Troyan Municipality, Lovech, 5600, Bulgaria

Location

Diagnostic Consultative Center 1- Lom EOOD

Lom, Montana, 3600, Bulgaria

Location

Medical Center Hera EOOD, Montana

Montana, Montana, 3400, Bulgaria

Location

Specialized Hospital for Active Treatment of Pulmonary Diseases- Pernik EOOD

Pernik, Pernik, 2300, Bulgaria

Location

Medical Center Prolet EOOD

Rousse, Ruse, 7002, Bulgaria

Location

Medical Center Hipocrena

Sevlievo, Sevlievo, 5400, Bulgaria

Location

Medical Center Hera EOOD

Sofia, Sofia, 1202, Bulgaria

Location

University Multiprofile Hospital for Active Treatment Sofiamed OOD

Sofia, Sofia, 1750, Bulgaria

Location

Medical Center Sanador M EOOD

Sofia, Sofia-Grad, 1431, Bulgaria

Location

Medical Centre Pratia Clinic EOOD Varna

Varna, Varna, Bulgaria

Location

Medical Center Tara OOD

Veliko Tarnovo, Veliko Tarnovo, 5000, Bulgaria

Location

Specialized Hospital for Active Treatment of Pneumophthisiatric Diseases - Haskovo EOOD

Haskovo, 6305, Bulgaria

Location

Medical Center Neuromedix EOOD

Veliko Tarnovo, 5006, Bulgaria

Location

Servicios de Salud IPS Suramericana S.A.S. - IPS Sura Industriales Medellin

Medellín, Antioquia, 50021, Colombia

Location

Clinica de la Costa Ltda - PPDS

Barranquilla, Atlántico, 080020, Colombia

Location

Clínica Universidad De la Sabana

Chía, Cundinamarca, 250001, Colombia

Location

Fundacion Centro de Investigaciones Clinicas IPS Cardiomet Pereira

Pereira, Risaralda Department, 660003, Colombia

Location

Oinsamed S.A.S - Clinica Misericordia

Barranquilla, 080020, Colombia

Location

Fundacion Centro de Investigacion Clinica CIC

Medellín, 050021, Colombia

Location

MUDr. Jakub Strincl, s.r.o.

Liberec, Liberecký kraj, 460 14, Czechia

Location

Res Medica s.r.o.

Nový Knín, 262 03, Czechia

Location

Hospital Miri

Miri, Sarawak, 98000, Malaysia

Location

Instituto Jalisciense de Investigacion Clinica SA de CV

Guadalajara, Jalisco, 44100, Mexico

Location

CICUM San Miguel

Guadalajara, Jalisco, 44160, Mexico

Location

Centro de Investigación Clinica Médica y Farmacoló

Guadalajara, Jalisco, 44690, Mexico

Location

Hospital Civil Fray Antonio Alcalde

Guadalajara, Jalisco, 45235, Mexico

Location

Centro de Atención e Investigación Médica S.A. - México - CAIMED - PPDS

Mexico City, Mexico City, 06760, Mexico

Location

Accelerium, S. de R.L. de C.V. - PPDS

Monterrey, Nuevo León, 31000, Mexico

Location

Camacho Ortiz, Adrian

Monterrey, Nuevo León, Mexico

Location

Centro de Alta Especialidad Dr. Rafael Lucio

Veracruz, Veracruz, 91020, Mexico

Location

FAICIC

Veracruz, Veracruz, 91700, Mexico

Location

Oaxaca Site Management Organization - Clinic - OSMO - PPDS

Oaxaca City, 68000, Mexico

Location

Centrum Medyczne PROFAMILIA

Lodz, Łódź Voivodeship, 91-463, Poland

Location

Plucna ambulancia Hrebenar, s.r.o.

Spišská Nová Ves, 052 01, Slovakia

Location

Newtown Clinical Research Centre

Johannesburg, 2001, South Africa

Location

Be Part Yoluntu Centre

Paarl, 7646, South Africa

Location

Hospital General Universitario Dr. Balmis

Alicante, Alicante, 03010, Spain

Location

Centro de salud Cabra Matrona Antonia Mesa Fernández

Cabra, Cordoba, 14940, Spain

Location

CHUS - H. Clinico U. de Santiago

Santiago de Compostela, 15706, Spain

Location

Taichung Veterans General Hospital

Taichung, 40705, Taiwan

Location

Tri-Service General Hospital

Taipei, 11490, Taiwan

Location

MeSH Terms

Conditions

Respiratory Syncytial Virus Infections

Interventions

EDP-938

Condition Hierarchy (Ancestors)

Pneumovirus Infections; Paramyxoviridae Infections; Mononegavirales Infections; RNA Virus Infections; Virus Diseases; Infections

Study Officials

• Enanta Pharmaceuticals, Inc

  Enanta Pharmaceuticals, Inc

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 3, 2022
• First Posted: October 6, 2022
• Study Start: November 29, 2022
• Primary Completion: June 23, 2025
• Study Completion: June 23, 2025
• Last Updated: July 1, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

TW (2); CZ (2); AR (7); MY (1); ES (3); ME (10); CO (6); US (31); PL (1); BU (18); SL (1); ZA (2)