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

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

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.

Study Overview

• Status: Completed
• Conditions: RSV Infection
• Intervention / Treatment: Drug: EDP-938; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 186
• Phase: Phase 2

Contacts and Locations

Study Locations

• Argentina
  • Santa Fe, Argentina, 3000
    • Instituto Del Buen Aire
  • Buenos Aires
    • La Plata, Buenos Aires, Argentina, 1900
      • Instituto Medico Platense
    • Mar Del Plata, Buenos Aires, Argentina, B7600FYK
      • Centro de Investigaciones Medica Mar del Plata
    • Munro, Buenos Aires, Argentina, B1605
      • Clinica Privada Independencia
  • Ciudad Autónoma de BuenosAires
    • Ciudad Autónoma de Buenos Aires, Ciudad Autónoma de BuenosAires, Argentina, C1426ABP
      • Consultorios Médicos Dr. Doreski
  • Cordoba
    • Río Cuarto, Cordoba, Argentina, 5800
      • Instituto Medico Rio Cuarto
  • Tucumán
    • San Miguel De Tucumán, Tucumán, Argentina, T4000NWB
      • Clínica Mayo de U.M.C.B. S.R.L
• Bulgaria
  • Blagoevgrad, Bulgaria, 2700
    • Multiprofile Hospital for Active Treatment Puls AD - PPDS
  • Burgas, Bulgaria, 8000
    • Medical Center For Life EOOD
  • Haskovo, Bulgaria, 6305
    • Specialized Hospital for Active Treatment of Pneumophthisiatric Diseases - Haskovo EOOD
  • Kozloduy, Bulgaria, 3320
    • Medical Center Zdrave-1 OOD
  • Kyustendil, Bulgaria, 2500
    • Medical Center Hera - Kyustendil EOOD
  • Montana, Bulgaria, 3400
    • Medical Center Hera EOOD, Montana
  • Pernik, Bulgaria, 2300
    • Specialized Hospital for Active Treatment of Pulmonary Diseases- Pernik EOOD
  • Ruse, Bulgaria, 7002
    • Medical Center Prolet Eood
  • Sevlievo, Bulgaria, 5400
    • Medical Center Hipocrena
  • Sofia, Bulgaria, 1202
    • Medical Center Hera EOOD
  • Sofia, Bulgaria, 1750
    • University Multiprofile Hospital for Active Treatment Sofiamed OOD
  • Varna, Bulgaria
    • Medical Centre Pratia Clinic EOOD Varna
  • Veliko Tarnovo, Bulgaria, 5000
    • Medical Center Tara OOD
  • Veliko Tarnovo, Bulgaria, 5006
    • Medical Center Neuromedix EOOD
  • Gabrovo
    • Sevlievo, Gabrovo, Bulgaria, 5400
      • Diagnostic Consultative Center-1-Sevlievo EOOD
  • Lovech
    • Troyan, Lovech, Bulgaria, 5600
      • Specialized Hospital for Active Treatment of Pulmonary Diseases
  • Montana
    • Lom, Montana, Bulgaria, 3600
      • Diagnostic Consultative Center 1- Lom EOOD
  • Sofia Grad
    • Sofia, Sofia Grad, Bulgaria, 1431
      • Medical Center Sanador M EOOD
• Colombia
  • Barranquilla, Colombia, 080020
    • Oinsamed S.A.S - Clinica Misericordia
  • Medellín, Colombia, 050021
    • Fundacion Centro de Investigacion Clinica CIC
  • Antioquia
    • Medellín, Antioquia, Colombia, 50021
      • Servicios de Salud IPS Suramericana S.A.S. - IPS Sura Industriales Medellin
  • Atlántico
    • Barranquilla, Atlántico, Colombia, 080020
      • Clinica de la Costa Ltda - PPDS
  • Cundinamarca
    • Chia, Cundinamarca, Colombia, 250001
      • Clínica Universidad de La Sabana
  • Risaralda
    • Pereira, Risaralda, Colombia, 660003
      • Fundación Centro De Investigaciones Clinicas Ips Cardiomet Pereira
• Czechia
  • Nový Knín, Czechia, 262 03
    • Res Medica s.r.o.
  • Liberecký kraj
    • Liberec, Liberecký kraj, Czechia, 460 14
      • MUDr. Jakub Strincl, s.r.o.
• Malaysia
  • Sarawak
    • Miri, Sarawak, Malaysia, 98000
      • Hospital Miri
• Mexico
  • Oaxaca de Juarez, Mexico, 68000
    • Oaxaca Site Management Organization - Clinic - OSMO - PPDS
  • Veracruz, Mexico, 91020
    • Centro de Alta Especialidad Dr. Rafael Lucio
  • Veracruz, Mexico, 91700
    • FAICIC
  • Distrito Federal
    • Ciudad de México, Distrito Federal, Mexico, 06760
      • Centro de Atención e Investigación Médica S.A. - México - CAIMED - PPDS
  • Jalisco
    • Guadalajara, Jalisco, Mexico, 44160
      • CICUM San Miguel
    • Guadalajara, Jalisco, Mexico, 44100
      • Instituto Jalisciense de Investigación Clínica Sa de Cv
    • Guadalajara, Jalisco, Mexico, 44690
      • Centro de Investigación Clinica Médica y Farmacoló
    • Guadalajara, Jalisco, Mexico, 45235
      • Hospital Civil Fray Antonio Alcalde
  • Nuevo León
    • Monterrey, Nuevo León, Mexico, 31000
      • Accelerium, S. de R.L. de C.V. - PPDS
    • Monterrey, Nuevo León, Mexico
      • Camacho Ortiz, Adrian
• Poland
  • Lodzkie
    • Łódź, Lodzkie, Poland, 91-463
      • Centrum Medyczne PROFAMILIA
• Slovakia
  • Spišská Nová Ves, Slovakia, 052 01
    • Plucna ambulancia Hrebenar, s.r.o.
• South Africa
  • Johannesburg, South Africa, 2001
    • Newtown Clinical Research Centre
  • Paarl, South Africa, 7646
    • Be Part Yoluntu Centre
• Spain
  • Alicante, Spain, 03010
    • Hospital General Universitario Dr. Balmis
  • Santiago De Compostela, Spain, 15706
    • CHUS - H. Clinico U. de Santiago
  • Cordoba
    • Cabra, Cordoba, Spain, 14940
      • Centro de salud Cabra Matrona Antonia Mesa Fernández
• Taiwan
  • Taichung, Taiwan, 40705
    • Taichung Veterans General Hospital
  • Taipei, Taiwan, 11490
    • Tri-Service General Hospital
• United States
  • Arizona
    • Tempe, Arizona, United States, 85282-2455
      • Voyage Medical
  • California
    • Fresno, California, United States, 93701
      • UCSF Fresno
    • Lomita, California, United States, 90717
      • Torrance Clinical Research Institute
    • Los Angeles, California, United States, 90017
      • Downtown LA Research Center Inc - ClinEdge - PPDS
    • Westminster, California, United States, 92683
      • Allianz Research Institute Inc
  • Colorado
    • Aurora, Colorado, United States, 80014
      • Allianz Research Institute - Colorado
  • Florida
    • Bay Pines, Florida, United States, 33744
      • Bay Pines VA Healthcare System
    • Cape Coral, Florida, United States, 33990
      • C&A Clinical Trials Corp
    • Cutler Bay, Florida, United States, 33157
      • Beautiful Minds Clinical Research Center
    • Hialeah, Florida, United States, 33015
      • Dinamo Research & Diagnostic Center, LLC
    • Kissimmee, Florida, United States, 34741
      • I.H.S Health LLC
    • Miami, Florida, United States, 33144
      • Dynamic Medical Research, LLC
    • Miami, Florida, United States, 33179-2537
      • Floridian Research Institute
    • Orlando, Florida, United States, 32827
      • Orlando VA Healthcare System
    • Ormond Beach, Florida, United States, 32174
      • Ormond Beach Clinical Research
    • Port Saint Lucie, Florida, United States, 34952
      • CDC Research Institute, LLC
    • Tampa, Florida, United States, 33615
      • Santos Research Center
    • Tampa, Florida, United States, 33607
      • Research Bay, Inc.
  • Georgia
    • East Point, Georgia, United States, 30344
      • Covenant Pulmonary Criticial Care and Research Ins
  • Idaho
    • Idaho Falls, Idaho, United States, 83404
      • Snake River Research
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • University of Louisville
  • Montana
    • Butte, Montana, United States, 59701
      • Mercury Street Medical
  • New York
    • Syracuse, New York, United States, 13210-1685
      • Global Health Institute
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27103
      • Progressive Medicine of the Triad, LLC
  • Ohio
    • Toledo, Ohio, United States, 43617
      • Toledo Institute of Clinical Research
  • Texas
    • Austin, Texas, United States, 78704-7507
      • IMA Clinical Research - Austin - PPDS
    • Fort Worth, Texas, United States, 76164-9041
      • Valley Institute of Research
    • Houston, Texas, United States, 77022
      • HDH Research, Inc.
    • McKinney, Texas, United States, 75069
      • Metroplex Pulmonary and Sleep Medicine Center-4833 Medical Center Dr Unit 6B
    • Mesquite, Texas, United States, 75149
      • SMS Clinical Research, LLC
  • Washington
    • Redmond, Washington, United States, 98052
      • Eastside Research Associates

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: EDP-938; EDP-938 800 mg, once daily	Drug: EDP-938; Subjects will take EDP-938 once daily for 5 days
Placebo Comparator: Placebo; Matching placebo, once daily	Drug: Placebo; Subjects will take matching placebo, once daily for 5 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Time to resolution of RSV Lower Respiratory Tract Disease (LRTD) symptoms	Day 1 through Day 33

Secondary Outcome Measures

Outcome Measure	Time Frame
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
Time to no or mild impact of RSV disease on daily activities, emotions, and social relationships	Day 1 through Day 33
Percentage of participants with post-baseline RSV-related complications	Day 1 through Day 33
Time to improvement in RSV disease	Day 1 through Day 33
Change from Baseline for Health-Related Quality of Life	Day 1 through Day 33
Time to return to usual health	Day 1 through Day 33
Time to return to usual activities	Day 1 through Day 33
Percentage of subjects requiring hospitalization for RSV or other causes;	Day 1 through Day 33
Duration of hospitalization for RSV or other causes	Day 1 through Day 33
All-cause mortality	Day 1 through Day 33
RSV RNA viral load change from Baseline	Days 3, 5, 9, and 14
Change in infectious RSV viral load over time	Up to Day 14
Plasma PK Concentrations of EDP-938	Up to Day 5
Safety as measured by frequency of adverse events (AEs)	Up to Day 33

Collaborators and Investigators

• Sponsor: Enanta Pharmaceuticals, Inc
• Investigators: Study Director: Enanta Pharmaceuticals, Inc, Enanta Pharmaceuticals, Inc

Study record dates

Study Major Dates

• Study Start (Actual): November 29, 2022
• Primary Completion (Actual): June 23, 2025
• Study Completion (Actual): June 23, 2025

Study Registration Dates

• First Submitted: October 3, 2022
• First Submitted That Met QC Criteria: October 3, 2022
• First Posted (Actual): October 6, 2022

Study Record Updates

• Last Update Posted (Estimated): July 1, 2025
• Last Update Submitted That Met QC Criteria: June 26, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: High Risk, Respiratory Syncytial Virus
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Pneumovirus Infections; Paramyxoviridae Infections; Mononegavirales Infections; Infections; Respiratory Syncytial Virus Infections
• Other Study ID Numbers: EDP 938-104

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No