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

Last updated: April 23, 2025
Sponsor: Enanta Pharmaceuticals, Inc
Overall Status: Active - Recruiting

Phase

2

Condition

Respiratory Syncytial Virus (Rsv) Infection

Respiratory Syncytial Virus (Rsv)

Treatment

Placebo

EDP-938

Clinical Study ID

NCT05568706
EDP 938-104
  • Ages > 18
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  • At least one of the following conditions that predispose them to complications afterRSV 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 ofpre-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: feelingfeverish, headache, neck pain, fatigue, loss of appetite, interrupted sleep, bodyaches, sore throat, nasal congestion, cough, cough with phlegm, wheezing, or shortof breath.

  • The subject reports at least 2 of the following symptoms, one of which must bereported as at least 'moderate' severity: cough, cough with phlegm, wheezing, orshort of breath

  • The subject has tested positive for RSV infection using a NAAT (polymerase chainreaction [PCR] or other) on a nasal/nasopharyngeal swab sample.

  • A woman of childbearing potential who is sexually active with a male must agree touse two effective methods of contraception from the date of Screening until 30 daysafter her last dose of study drug.

  • A male subject who has not had a vasectomy and is sexually active with a woman ofchildbearing potential must agree to use effective contraception from the date ofScreening to 90 days after his last dose of study drug.

Exclusion

Exclusion Criteria:

  • The subject has an anticipated need for hospitalization within 24 hours of signingthe Study ICF

  • The subject receives systemic antiviral, antibacterial, antifungal, orantimycobacterial therapy within 7 days prior to signing the Study ICF

  • The subject has concomitant respiratory infections that are viral (other than RSVbut including influenza), bacterial, or fungal, including systemic bacterial orfungal 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 tosigning the Study ICF

  • The subject has COPD with spirometry results (obtained within 1 year prior tosigning the Study ICF) FEV1 ≤35%

  • The subject has a known positive human immunodeficiency virus infection, activehepatitis A virus infection, chronic hepatitis B virus infection, and/or currenthepatitis C virus (HCV) infection; subjects with a history of HCV infection who haveachieved a documented sustained virologic response 12 weeks after completion of HCVtherapy may be enrolled.

  • The subject has any of the following cardiac conditions: any congenital heartdisease, congenital long QT syndrome, or any clinical manifestation resulting in QTinterval prolongation

  • The subject has immunocompromised status

  • The subject is living in institutional care or assisted living facility and is alsoreceiving acute care management for any respiratory condition; Note: Independentliving apartments are not considered institutional care or assisted living facility

Study Design

Total Participants: 180
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 2
Study Start date:
November 29, 2022
Estimated Completion Date:
June 30, 2025

Connect with a study center

  • Instituto De Enfermedades Respiratorias E Investigacion Medica

    Florencio Varela, Buenos Aires 1888
    Argentina

    Site Not Available

  • Instituto De Enfermedades Respiratorias E Investigacion Medica

    Florencio Varela, Buenos Aires 1888
    Argentina

    Site Not Available

  • Instituto Medico Platense

    La Plata, Buenos Aires 1900
    Argentina

    Active - Recruiting

  • Centro de Investigaciones Medica Mar del Plata

    Mar Del Plata, Buenos Aires B7600FYK
    Argentina

    Active - Recruiting

  • Clinica Privada Independencia

    Munro, Buenos Aires B1605
    Argentina

    Active - Recruiting

  • Consultorios Médicos Dr. Doreski

    Ciudad Autónoma de Buenos Aires, Ciudad Autónoma de BuenosAires C1426ABP
    Argentina

    Active - Recruiting

  • Instituto Médico Río Cuarto

    Río Cuarto, Cordoba 5800
    Argentina

    Active - Recruiting

  • Centro de Investigaciones Médicas Tucumán

    San Miguel De Tucumán, San Miguel T4000AXL
    Argentina

    Site Not Available

  • Instituto Médico de la Fundación Estudios Clínicos

    Rosario, Santa Fe S2013DTC
    Argentina

    Site Not Available

  • Clinica Mayo de U.M.C.B. S.R.L

    San Miguel De Tucumán, Tucumán T4000NWB
    Argentina

    Active - Recruiting

  • Instituto De Patologías Respiratorias

    San Miguel de Tucumán, Tucumán 4000
    Argentina

    Site Not Available

  • CINME S.A. - Centro de Investigaciones Metabólicas - Rx Trials LLC

    Buenos Aires, C1221ABL
    Argentina

    Site Not Available

  • Instituto de Medicina Respiratoria, IMeR

    Córdoba, X5000DCE
    Argentina

    Site Not Available

  • INSARES

    Mendoza, M5500CCG
    Argentina

    Site Not Available

  • Instituto Del Buen Aire

    Santa Fe, 3000
    Argentina

    Active - Recruiting

  • L2 Ip - Instituto de Pesquisas Clinicas Ltda - ME

    Brasília, Distrito Federal 70200-715
    Brazil

    Site Not Available

  • Hospital de Clinicas de Porto Alegre (HCPA) - PPDS

    Porto Alegre, Rio Grande do Sul 90035-001
    Brazil

    Site Not Available

  • DASA - Complexo Hospitalar de Niteroi - PPDS

    Niteroi, Rio de Janeiro 24020-096
    Brazil

    Site Not Available

  • IBPCLIN Instituto Brasil de Pesquisa Clínica

    Rio De Janeiro, 22271-100
    Brazil

    Site Not Available

  • Instituto D'Or Pesquisa e Ensino - Hospital Glória D´Or

    Rio De Janeiro, 21040-360
    Brazil

    Site Not Available

  • CPCLIN Centro de Pesquisas Clínicas Ltda

    Sao Paulo,
    Brazil

    Site Not Available

  • Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo

    São Paulo, 05403-000
    Brazil

    Site Not Available

  • Diagnostic Consultative Center-1-Sevlievo EOOD

    Sevlievo, Gabrovo 5400
    Bulgaria

    Active - Recruiting

  • Specialized Hospital for Active Treatment of Pulmonary Diseases

    Troyan, Lovech 5600
    Bulgaria

    Active - Recruiting

  • Diagnostic Consultative Center 1- Lom EOOD

    Lom, Montana 3600
    Bulgaria

    Active - Recruiting

  • Medical Center Medconsult Pleven OOD

    Pleven, Plevan 5800
    Bulgaria

    Site Not Available

  • Medical Center Sanador M EOOD

    Sofia, Sofia Grad 1431
    Bulgaria

    Active - Recruiting

  • Multiprofile Hospital for Active Treatment Puls AD - PPDS

    Blagoevgrad, 2700
    Bulgaria

    Active - Recruiting

  • Medical Center For Life EOOD

    Burgas, 8000
    Bulgaria

    Active - Recruiting

  • Specialized Hospital for Active Treatment of Pneumophthisiatric Diseases - Haskovo EOOD

    Haskovo, 6305
    Bulgaria

    Active - Recruiting

  • Medical Center Zdrave-1 OOD

    Kozloduy, 3320
    Bulgaria

    Active - Recruiting

  • Medical Center Hera - Kyustendil EOOD

    Kyustendil, 2500
    Bulgaria

    Active - Recruiting

  • Medical Center Hera EOOD, Montana

    Montana, 3400
    Bulgaria

    Active - Recruiting

  • Specialized Hospital for Active Treatment of Pulmonary Diseases- Pernik EOOD

    Pernik, 2300
    Bulgaria

    Active - Recruiting

  • Medical Center Prolet EOOD

    Ruse, 7002
    Bulgaria

    Active - Recruiting

  • Medical Center Hipocrena

    Sevlievo, 5400
    Bulgaria

    Active - Recruiting

  • Medical Center Hera EOOD

    Sofia, 1202
    Bulgaria

    Active - Recruiting

  • University Multiprofile Hospital for Active Treatment Sofiamed OOD

    Sofia, 1750
    Bulgaria

    Active - Recruiting

  • Medical Center Leo Clinic EOOD, Varna

    Varna,
    Bulgaria

    Active - Recruiting

  • Medical Centre Pratia Clinic EOOD Varna

    Varna,
    Bulgaria

    Active - Recruiting

  • Medical Center Neuromedix EOOD

    Veliko Tarnovo, 5006
    Bulgaria

    Active - Recruiting

  • Medical Center Tara OOD

    Veliko Tarnovo, 5000
    Bulgaria

    Active - Recruiting

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

    Medellín, Antioquia 50021
    Colombia

    Active - Recruiting

  • Clinica de la Costa Ltda - PPDS

    Barranquilla, Atlántico 080020
    Colombia

    Active - Recruiting

  • Clínica Universidad De la Sabana

    Chia, Cundinamarca 250001
    Colombia

    Active - Recruiting

  • Fundacion Centro de Investigaciones Clinicas IPS Cardiomet Pereira

    Pereira, Risaralda 660003
    Colombia

    Active - Recruiting

  • Oinsamed S.A.S - Clinica Misericordia

    Barranquilla, 080020
    Colombia

    Active - Recruiting

  • Fundacion Centro de Investigacion Clinica CIC

    Medellín, 050021
    Colombia

    Active - Recruiting

  • MediTrial s.r.o.

    Jindřichův Hradec, Jihoceský kraj 377 01
    Czechia

    Site Not Available

  • Praktický lékar Všestary s.r.o

    Všestary, Královéhradecký kraj 503 12
    Czechia

    Site Not Available

  • MUDr. Jakub Strincl, s.r.o.

    Liberec, Liberecký kraj 460 14
    Czechia

    Active - Recruiting

  • Progerint s.r.o.

    Vysoké Mýto, Pardubický kraj 566 01
    Czechia

    Site Not Available

  • Res Medica s.r.o.

    Nový Knín, 262 03
    Czechia

    Active - Recruiting

  • MEDISON, s.r.o.

    Přeštice, 334 01
    Czechia

    Site Not Available

  • Ordinace Hradební s.r.o.

    České Budějovice, 370 01
    Czechia

    Site Not Available

  • Matan Clinic Clalit

    Matan, HaMerkaz 45858
    Israel

    Site Not Available

  • Clalit HMO - Atlit

    Atlit, Haifa 30300
    Israel

    Site Not Available

  • Sultan Ahmad Shah Medical Centre at IIUM

    Kuantan, Pahang 25200
    Malaysia

    Site Not Available

  • Hospital Miri

    Miri, Sarawak 98000
    Malaysia

    Active - Recruiting

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

    Ciudad de México, Distrito Federal 06760
    Mexico

    Active - Recruiting

  • CICUM San Miguel

    Guadalajara, Jalisco 44160
    Mexico

    Active - Recruiting

  • Centro de Investigación Clinica Médica y Farmacoló

    Guadalajara, Jalisco 44690
    Mexico

    Active - Recruiting

  • Hospital Civil Fray Antonio Alcalde

    Guadalajara, Jalisco 45235
    Mexico

    Active - Recruiting

  • Instituto Jalisciense de Investigacion Clinica SA de CV

    Guadalajara, Jalisco 44100
    Mexico

    Active - Recruiting

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

    Monterrey, Nuevo León 31000
    Mexico

    Active - Recruiting

  • Camacho Ortiz, Adrian

    Monterrey, Nuevo León
    Mexico

    Active - Recruiting

  • Oaxaca Site Management Organization - Clinic - OSMO - PPDS

    Oaxaca de Juarez, 68000
    Mexico

    Active - Recruiting

  • Centro de Alta Especialidad Dr. Rafael Lucio

    Veracruz, 91020
    Mexico

    Active - Recruiting

  • FAICIC

    Veracruz, 91700
    Mexico

    Active - Recruiting

  • Huisartsenpraktijk Broekman

    Rotterdam, Zuid-Holland 3051 GV
    Netherlands

    Site Not Available

  • Office of Dr Mangal

    Rotterdam, Zuid-Holland 3051 GV
    Netherlands

    Site Not Available

  • Office of Dr Rambharose

    Rotterdam, Zuid-Holland 3051-GV
    Netherlands

    Site Not Available

  • Office of Dr Verkleij

    Rotterdam, Zuid-Holland 3051 GV
    Netherlands

    Site Not Available

  • Office of Dr van Soerland

    Rotterdam, Zuid-Holland 3051 GV
    Netherlands

    Site Not Available

  • Qclinical B.V.

    Rotterdam, Zuid-Holland 3051 GV
    Netherlands

    Site Not Available

  • Healthlink Medicalsurgicaldental Clinic and Diagnostic Center

    Iloilo City, Iloilo 5000
    Philippines

    Site Not Available

  • Chinese Gen. Hospital and MC

    Manila City, 1014
    Philippines

    Site Not Available

  • Centrum Badan Klinicznych Piotr Napora Lekarze Spolka Partnerska

    Wrocław, Dolnoslaskie 51-162
    Poland

    Site Not Available

  • Centrum Medyczne PROFAMILIA

    Łódź, Lodzkie 91-463
    Poland

    Completed

  • NZOZ IGNIS dr med. Alicja Lobinska

    Świdnik, Lubelskie 21-040
    Poland

    Site Not Available

  • Alergo-Med Specjalistyczna Przychodnia Lekarska Sp. z.o.o

    Tarnów, Malopolskie 33-100
    Poland

    Site Not Available

  • EMC Instytut Medyczny S.A.PL CERTUS Szpital i Ambulatorium

    Poznań, Wielkopolskie 60-309
    Poland

    Site Not Available

  • Specjalistyczny Osrodek Leczniczo-Badawczy Zbigniew Zegota

    Ostróda, 14-100
    Poland

    Site Not Available

  • PULMAG Grzegorz Gasior Marzena Kociolek Spolka Cywilna

    Sosnowiec, 41-208
    Poland

    Site Not Available

  • Caribbean Medical Research Center

    San Juan, 00918
    Puerto Rico

    Site Not Available

  • ALIAN, s.r.o

    Bardejov, 085 01
    Slovakia

    Site Not Available

  • Plucna ambulancia Hrebenar, s.r.o.

    Spišská Nová Ves, 052 01
    Slovakia

    Active - Recruiting

  • Enhancing Care Foundation

    Durban, Kwazulu-Natal 4319
    South Africa

    Site Not Available

  • Zinakekele Medical Centre

    Kwamhlanga, Mpumalanga 1022
    South Africa

    Site Not Available

  • Tiervlei Trial Centre-43 Old Oak Road

    Cape Town, 7530
    South Africa

    Site Not Available

  • Newtown Clinical Research Centre

    Johannesburg, 2001
    South Africa

    Completed

  • Be Part Yoluntu Centre

    Paarl, 7646
    South Africa

    Completed

  • Clinical Trial Systems

    Pretoria,
    South Africa

    Site Not Available

  • Centro de salud Cabra Matrona Antonia Mesa Fernández

    Cabra, Cordoba 14940
    Spain

    Active - Recruiting

  • Hospital Costa del Sol

    Marbella, Malaga 29600
    Spain

    Site Not Available

  • Hospital General Universitario Dr. Balmis

    Alicante, 03010
    Spain

    Active - Recruiting

  • Hospital HM Nou Delfos

    Barcelona, 08023
    Spain

    Site Not Available

  • CHUS - H. Clinico U. de Santiago

    Santiago De Compostela, 15706
    Spain

    Active - Recruiting

  • Kaohsiung Medical University - Chung-Ho Memorial Hospital

    Kaohsiung City, 807
    Taiwan

    Site Not Available

  • Taichung Veterans General Hospital

    Taichung, 40705
    Taiwan

    Completed

  • National Taiwan University Hospital

    Taipei,
    Taiwan

    Site Not Available

  • Taipei Municipal Wanfang Hospital

    Taipei, 116
    Taiwan

    Site Not Available

  • Tri-Service General Hospital

    Taipei, 11490
    Taiwan

    Completed

  • Longwood Research

    Huntsville, Alabama 35801
    United States

    Site Not Available

  • Voyage Medical

    Tempe, Arizona 85282-2455
    United States

    Completed

  • UCSF Fresno

    Fresno, California 93701
    United States

    Completed

  • Ascada Research LLC

    Fullerton, California 92835-3424
    United States

    Site Not Available

  • Torrance Clinical Research Institute

    Lomita, California 90717
    United States

    Completed

  • Downtown LA Research Center Inc - ClinEdge - PPDS

    Los Angeles, California 90017
    United States

    Active - Recruiting

  • Velocity Clinical Research

    Los Angeles, California 90057
    United States

    Site Not Available

  • Capitis Medical And Aesthetics

    Roseville, California 95678-2474
    United States

    Site Not Available

  • CRMD Research LLC

    San Bernardino, California 92408-3406
    United States

    Site Not Available

  • Velocity Clinical Research

    Westlake, California 90057
    United States

    Site Not Available

  • Allianz Research Institute Inc

    Westminster, California 92683
    United States

    Completed

  • Allianz Research Institute - Colorado

    Aurora, Colorado 80014
    United States

    Completed

  • Allianz Research Institute

    Denver, Colorado 80219
    United States

    Site Not Available

  • Bay Pines VA Healthcare System

    Bay Pines, Florida 33744
    United States

    Active - Recruiting

  • C&A Clinical Trials Corp

    Cape Coral, Florida 33990
    United States

    Active - Recruiting

  • Beautiful Minds Clinical Research Center

    Cutler Bay, Florida 33157
    United States

    Active - Recruiting

  • Dinamo Research & Diagnostic center, LLC

    Hialeah, Florida 33015
    United States

    Active - Recruiting

  • I.H.S Health LLC

    Kissimmee, Florida 34741
    United States

    Terminated

  • Dynamic Medical Research, LLC

    Miami, Florida 33144
    United States

    Active - Recruiting

  • Floridian Research Institute

    Miami, Florida 33179-2537
    United States

    Active - Recruiting

  • Optimus U Corp

    Miami, Florida 33135
    United States

    Site Not Available

  • San Marcus Research Clinic Inc

    Miami, Florida 33014
    United States

    Site Not Available

  • Myrak Research Center Inc.

    Miami Lakes, Florida 33014-2406
    United States

    Site Not Available

  • Palm Springs Community Health Center

    Miami Lakes, Florida 33014
    United States

    Site Not Available

  • Florida Institute For Clinical Research LLC

    Orlando, Florida 32825
    United States

    Site Not Available

  • Orlando VA Healthcare System

    Orlando, Florida 32827
    United States

    Active - Recruiting

  • Ormond Beach Clinical Research

    Ormond Beach, Florida 32174
    United States

    Completed

  • CDC Research Institute, LLC

    Port Saint Lucie, Florida 34952
    United States

    Active - Recruiting

  • Research Bay, Inc.

    Tampa, Florida 33607
    United States

    Active - Recruiting

  • Santos Research Center

    Tampa, Florida 33615
    United States

    Active - Recruiting

  • Acute Care Emergence

    Columbus, Georgia 31909-1723
    United States

    Active - Recruiting

  • Columbus Regional Research Institute - Centricity - PPDS

    Columbus, Georgia 31909-1723
    United States

    Site Not Available

  • Covenant Pulmonary Criticial Care and Research Ins

    East Point, Georgia 30344
    United States

    Active - Recruiting

  • Southeast Lung Associates Research

    Rincon, Georgia 31326
    United States

    Site Not Available

  • Snake River Research

    Idaho Falls, Idaho 83404
    United States

    Active - Recruiting

  • Medisphere Medical Research Center LLC

    Evansville, Indiana 47712
    United States

    Site Not Available

  • Del Pilar Medical and Urgent Care

    Mishawaka, Indiana 46545
    United States

    Site Not Available

  • University of Louisville

    Louisville, Kentucky 40202
    United States

    Active - Recruiting

  • Velocity Clinical Research - Covington - PPDS

    Lafayette, Louisiana 70508
    United States

    Site Not Available

  • Medical Arts Research Center

    Madison Heights, Michigan 48071
    United States

    Site Not Available

  • Velocity Clinical Research - Gulfport - PPDS

    Gulf Port, Mississippi 39503
    United States

    Site Not Available

  • Velocity Clinical Research - Gulfport - PPDS

    Gulfport, Mississippi 39503
    United States

    Site Not Available

  • Safe Haven Clinical Research

    Vicksburg, Mississippi 39183-4408
    United States

    Site Not Available

  • Mercury Street Medical

    Butte, Montana 59701
    United States

    Completed

  • Nebraska Medical Research Institute, Inc

    Bellevue, Nebraska 68046
    United States

    Site Not Available

  • Clinical Research of South Nevada - Clinedge - PPDS

    Las Vegas, Nevada 89121
    United States

    Site Not Available

  • Raritan Bay Primary Care & Cardiology Associates

    Old Bridge, New Jersey 08857
    United States

    Site Not Available

  • Global Health Institute

    Syracuse, New York 13210-1685
    United States

    Active - Recruiting

  • Burke Primary Care

    Morganton, North Carolina 28655
    United States

    Site Not Available

  • Progressive Medicine of the Triad, LLC

    Winston-Salem, North Carolina 27103
    United States

    Completed

  • Helios CR, Inc. - Cleveland - PPDS

    Middleburg Heights, Ohio 44130
    United States

    Site Not Available

  • Toledo Institute of Clinical Research

    Toledo, Ohio 43617
    United States

    Active - Recruiting

  • Main Street Physicians Care

    Little River, South Carolina 29566
    United States

    Site Not Available

  • Spartanburg Medical Research

    Spartanburg, South Carolina 29303
    United States

    Site Not Available

  • ClinSearch, LLC - M3 WR

    Chattanooga, Tennessee 37421-1651
    United States

    Site Not Available

  • Helios CR, Inc. - Stonecreek Circle - Jackson - PPDS

    Jackson, Tennessee 38305
    United States

    Site Not Available

  • Accelemed Research Institute

    Austin, Texas 78704-7507
    United States

    Active - Recruiting

  • IMA Clinical Research - Austin - PPDS

    Austin, Texas 78704-7507
    United States

    Active - Recruiting

  • Inquest Clinical Research

    Baytown, Texas 77521
    United States

    Site Not Available

  • Global Medical Research

    Dallas, Texas 75039
    United States

    Site Not Available

  • GLRI El Paso Research

    El Paso, Texas 79936
    United States

    Site Not Available

  • Valley Institute of Research

    Fort Worth, Texas 76164-9041
    United States

    Active - Recruiting

  • Aqua Research Institute, LLC

    Houston, Texas 77058
    United States

    Site Not Available

  • HDH Research, Inc.

    Houston, Texas 77022
    United States

    Active - Recruiting

  • Sacred Ground Research

    Humble, Texas 77338
    United States

    Site Not Available

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

    McKinney, Texas 75069
    United States

    Active - Recruiting

  • SMS Clinical Research, LLC

    Mesquite, Texas 75149
    United States

    Active - Recruiting

  • Olympus Clinical Research, LLC

    Sugar Land, Texas 77479
    United States

    Site Not Available

  • Eastside Research Associates

    Redmond, Washington 98052
    United States

    Active - Recruiting

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