A Study of EDP-938 in Non-hospitalized Adults With RSV Who Are at High Risk for Complications.
NCT ID: NCT05568706
Last Updated: 2025-07-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
186 participants
INTERVENTIONAL
2022-11-29
2025-06-23
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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EDP-938
EDP-938 800 mg, once daily
EDP-938
Subjects will take EDP-938 once daily for 5 days
Placebo
Matching placebo, once daily
Placebo
Subjects will take matching placebo, once daily for 5 days
Interventions
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EDP-938
Subjects will take EDP-938 once daily for 5 days
Placebo
Subjects will take matching placebo, once daily for 5 days
Eligibility Criteria
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Inclusion Criteria
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 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
18 Years
ALL
No
Sponsors
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Enanta Pharmaceuticals, Inc
INDUSTRY
Responsible Party
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Principal Investigators
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Enanta Pharmaceuticals, Inc
Role: STUDY_DIRECTOR
Enanta Pharmaceuticals, Inc
Locations
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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, Liberecký kraj, 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
Countries
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Other Identifiers
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EDP 938-104
Identifier Type: -
Identifier Source: org_study_id
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