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NCT05568706

PHASE2

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

Sponsor: Enanta Pharmaceuticals, Inc

View on ClinicalTrials.gov

Summary

This was 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 were 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

187

Start Date

2022-11-29

Completion Date

2025-06-23

Last Updated

2026-08-19

Healthy Volunteers

Conditions

RSV Infection

Interventions

DRUG

EDP-938

Subjects took EDP-938 once daily for 5 days

DRUG

Placebo

Subjects took matching placebo, once daily for 5 days

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 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

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

IMA Clinical Research - Austin - PPDS

Austin, Texas, United States

Valley Institute of Research

Fort Worth, Texas, United States

HDH Research, Inc.

Houston, Texas, United States

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

McKinney, Texas, United States

SMS Clinical Research, LLC

Mesquite, Texas, United States

Eastside Research Associates

Redmond, Washington, United States

Instituto Medico Platense

La Plata, Buenos Aires, Argentina

Centro de Investigaciones Medica Mar del Plata

Mar del Plata, Buenos Aires, Argentina

Clinica Privada Independencia

Munro, Buenos Aires, Argentina

Consultorios Médicos Dr. Doreski

Buenos Aires, Ciudad Autónoma de BuenosAires, Argentina

Instituto Médico Río Cuarto

Río Cuarto, Córdoba Province, Argentina

Instituto Del Buen Aire

Santa Fe, Santa Fe Province, Argentina

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

San Miguel de Tucumán, Tucumán Province, Argentina

Multiprofile Hospital for Active Treatment Puls AD - PPDS

Blagoevgrad, Blagoevgrad, Bulgaria

Medical Center For Life EOOD

Burgas, Burgas, Bulgaria

Diagnostic Consultative Center-1-Sevlievo EOOD

Sevlievo, Gabrovo, Bulgaria

Medical Center Zdrave-1 OOD

Kozloduy, Kozloduy, Bulgaria

Medical Center Hera - Kyustendil EOOD

Kyustendil, Kyustendil, Bulgaria

Specialized Hospital for Active Treatment of Pulmonary Diseases

Troyan Municipality, Lovech, Bulgaria

Diagnostic Consultative Center 1- Lom EOOD

Lom, Montana, Bulgaria

Medical Center Hera EOOD, Montana

Montana, Montana, Bulgaria

Specialized Hospital for Active Treatment of Pulmonary Diseases- Pernik EOOD

Pernik, Pernik, Bulgaria

Medical Center Prolet EOOD

Rousse, Ruse, Bulgaria

Medical Center Hipocrena

Sevlievo, Sevlievo, Bulgaria

Medical Center Hera EOOD

Sofia, Sofia, Bulgaria

University Multiprofile Hospital for Active Treatment Sofiamed OOD

Sofia, Sofia, Bulgaria

Medical Center Sanador M EOOD

Sofia, Sofia-Grad, Bulgaria

Medical Centre Pratia Clinic EOOD Varna

Varna, Varna, Bulgaria

Medical Center Tara OOD

Veliko Tarnovo, Veliko Tarnovo, Bulgaria

Specialized Hospital for Active Treatment of Pneumophthisiatric Diseases - Haskovo EOOD

Haskovo, Bulgaria

Medical Center Neuromedix EOOD

Veliko Tarnovo, Bulgaria

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

Medellín, Antioquia, Colombia

Clinica de la Costa Ltda - PPDS

Barranquilla, Atlántico, Colombia

Clínica Universidad De la Sabana

Chía, Cundinamarca, Colombia

Fundacion Centro de Investigaciones Clinicas IPS Cardiomet Pereira

Pereira, Risaralda Department, Colombia

Oinsamed S.A.S - Clinica Misericordia

Barranquilla, Colombia

Fundacion Centro de Investigacion Clinica CIC

Medellín, Colombia

MUDr. Jakub Strincl, s.r.o.

Liberec, Liberec Region, Czechia

Res Medica s.r.o.

Nový Knín, Czechia

Hospital Miri

Miri, Sarawak, Malaysia

Instituto Jalisciense de Investigacion Clinica SA de CV

Guadalajara, Jalisco, Mexico

CICUM San Miguel

Guadalajara, Jalisco, Mexico

Centro de Investigación Clinica Médica y Farmacoló

Guadalajara, Jalisco, Mexico

Hospital Civil Fray Antonio Alcalde

Guadalajara, Jalisco, Mexico

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

Mexico City, Mexico City, Mexico

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

Monterrey, Nuevo León, Mexico

Camacho Ortiz, Adrian

Monterrey, Nuevo León, Mexico

Centro de Alta Especialidad Dr. Rafael Lucio

Veracruz, Veracruz, Mexico

FAICIC

Veracruz, Veracruz, Mexico

Oaxaca Site Management Organization - Clinic - OSMO - PPDS

Oaxaca City, Mexico

Centrum Medyczne PROFAMILIA

Lodz, Łódź Voivodeship, Poland

Plucna ambulancia Hrebenar, s.r.o.

Spišská Nová Ves, Slovakia

Newtown Clinical Research Centre

Johannesburg, South Africa

Be Part Yoluntu Centre

Paarl, South Africa

Hospital General Universitario Dr. Balmis

Alicante, Alicante, Spain

Centro de salud Cabra Matrona Antonia Mesa Fernández

Cabra, Cordoba, Spain

CHUS - H. Clinico U. de Santiago

Santiago de Compostela, Spain

Taichung Veterans General Hospital

Taichung, Taiwan

Tri-Service General Hospital

Taipei, Taiwan

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (84)