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

• Study Type: Interventional
• Enrollment (Estimated): 180
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Enanta Pharmaceuticals, Inc; Phone Number: 617 607-0800; Email: charris@enanta.com

Study Locations

• Argentina
  • Buenos Aires, Argentina, C1221ABL
    • Recruiting
    • CINME S.A. - Centro de Investigaciones Metabólicas - Rx Trials LLC
  • Córdoba, Argentina, X5000DCE
    • Recruiting
    • Instituto de Medicina Respiratoria, IMeR
  • Santa Fe, Argentina, 3000
    • Recruiting
    • Instituto Del Buen Aire
  • Buenos Aires
    • Florencio Varela, Buenos Aires, Argentina, 1888
      • Recruiting
      • Instituto De Enfermedades Respiratorias E Investigacion Medica
    • La Plata, Buenos Aires, Argentina, 1900
      • Recruiting
      • Instituto Medico Platense
    • Mar Del Plata, Buenos Aires, Argentina, B7600FYK
      • Recruiting
      • Centro de Investigaciones Medica Mar del Plata
    • Munro, Buenos Aires, Argentina, B1605
      • Recruiting
      • Clínica Privada Independencia
  • Ciudad Autónoma De BuenosAires
    • Ciudad Autónoma de Buenos Aires, Ciudad Autónoma De BuenosAires, Argentina, C1426ABP
      • Recruiting
      • Consultorios Médicos Dr. Doreski
  • Cordoba
    • Río Cuarto, Cordoba, Argentina, 5800
      • Recruiting
      • Instituto Medico Rio Cuarto
  • San Miguel
    • San Miguel De Tucumán, San Miguel, Argentina, T4000AXL
      • Recruiting
      • Centro de Investigaciones Medicas Tucuman
  • Santa Fe
    • Rosario, Santa Fe, Argentina, S2013DTC
      • Recruiting
      • Instituto Médico de la Fundación Estudios Clinicos
  • Tucumán
    • San Miguel De Tucumán, Tucumán, Argentina, T4000NWB
      • Recruiting
      • Clinica Mayo de U.M.C.B. S.R.L
• Brazil
  • Sao Paulo, Brazil
    • Recruiting
    • CPCLIN Centro de Pesquisas Clínicas Ltda
  • Distrito Federal
    • Brasília, Distrito Federal, Brazil, 70200-715
      • Recruiting
      • L2 Ip - Instituto de Pesquisas Clinicas Ltda - ME
• Bulgaria
  • Blagoevgrad, Bulgaria, 2700
    • Recruiting
    • Multiprofile Hospital for Active Treatment Puls AD - PPDS
  • Burgas, Bulgaria, 8000
    • Recruiting
    • Medical Center For Life EOOD
  • Kozloduy, Bulgaria, 3320
    • Recruiting
    • Medical Center Zdrave-1 OOD
  • Kyustendil, Bulgaria, 2500
    • Recruiting
    • Medical Center Hera - Kyustendil EOOD
  • Montana, Bulgaria, 3400
    • Recruiting
    • Medical Center Hera EOOD, Montana
  • Pernik, Bulgaria, 2300
    • Recruiting
    • Specialized Hospital for Active Treatment of Pulmonary Diseases- Pernik EOOD
  • Ruse, Bulgaria, 7002
    • Recruiting
    • Medical Center Prolet EOOD
  • Sevlievo, Bulgaria, 5400
    • Recruiting
    • Medical Center Hipocrena
  • Sofia, Bulgaria, 1202
    • Recruiting
    • Medical Center Hera Eood
  • Sofia, Bulgaria, 1750
    • Recruiting
    • University Multiprofile Hospital for Active Treatment Sofiamed OOD
  • Varna, Bulgaria
    • Recruiting
    • Medical Center Leo Clinic EOOD, Varna
  • Veliko Tarnovo, Bulgaria, 5000
    • Recruiting
    • Medical Center Tara OOD
  • Veliko Tarnovo, Bulgaria, 5006
    • Recruiting
    • Medical Center Neuromedix EOOD
  • Gabrovo
    • Sevlievo, Gabrovo, Bulgaria, 5400
      • Recruiting
      • Diagnostic Consultative Center-1-Sevlievo EOOD
  • Lovech
    • Troyan, Lovech, Bulgaria, 5600
      • Recruiting
      • Specialized Hospital for Active Treatment of Pulmonary Diseases
  • Montana
    • Lom, Montana, Bulgaria, 3600
      • Recruiting
      • Diagnostic Consultative Center 1- Lom EOOD
  • Plevan
    • Pleven, Plevan, Bulgaria, 5800
      • Recruiting
      • Medical Center Medconsult Pleven Ood
  • Sofia Grad
    • Sofia, Sofia Grad, Bulgaria, 1431
      • Recruiting
      • Medical Center Sanador M EOOD
• Czechia
  • Nový Knín, Czechia, 262 03
    • Recruiting
    • Res Medica s.r.o.
  • Přeštice, Czechia, 334 01
    • Recruiting
    • MEDISON, s.r.o.
  • České Budějovice, Czechia, 370 01
    • Recruiting
    • Ordinace Hradebni s.r.o.
  • Jihoceský Kraj
    • Jindřichův Hradec, Jihoceský Kraj, Czechia, 377 01
      • Recruiting
      • MediTrial s.r.o.
  • Královéhradecký Kraj
    • Všestary, Královéhradecký Kraj, Czechia, 503 12
      • Recruiting
      • Praktický lékar Všestary s.r.o
  • Liberecký Kraj
    • Liberec, Liberecký Kraj, Czechia, 460 14
      • Recruiting
      • MUDr. Jakub Strincl, s.r.o.
  • Pardubický Kraj
    • Vysoké Mýto, Pardubický Kraj, Czechia, 566 01
      • Recruiting
      • Progerint s.r.o.
• Israel
  • HaMerkaz
    • Matan, HaMerkaz, Israel, 45858
      • Recruiting
      • Matan Clinic Clalit
  • Haifa
    • Atlit, Haifa, Israel, 30300
      • Recruiting
      • Clalit HMO - Atlit
• Malaysia
  • Pahang
    • Kuantan, Pahang, Malaysia, 25200
      • Recruiting
      • Sultan Ahmad Shah Medical Centre at IIUM
• Netherlands
  • Zuid-Holland
    • Rotterdam, Zuid-Holland, Netherlands, 3051 GV
      • Recruiting
      • Huisartsenpraktijk Broekman
    • Rotterdam, Zuid-Holland, Netherlands, 3051 GV
      • Recruiting
      • Office of Dr Mangal
    • Rotterdam, Zuid-Holland, Netherlands, 3051 GV
      • Recruiting
      • Office of Dr van Soerland
    • Rotterdam, Zuid-Holland, Netherlands, 3051 GV
      • Recruiting
      • Office of Dr Verkleij
    • Rotterdam, Zuid-Holland, Netherlands, 3051 GV
      • Recruiting
      • Qclinical B.V.
    • Rotterdam, Zuid-Holland, Netherlands, 3051-GV
      • Recruiting
      • Office of Dr Rambharose
• Poland
  • Ostróda, Poland, 14-100
    • Recruiting
    • Specjalistyczny Osrodek Leczniczo-Badawczy Zbigniew Zegota
  • Sosnowiec, Poland, 41-208
    • Recruiting
    • PULMAG Grzegorz Gasior Marzena Kociolek Spolka Cywilna
  • Dolnoslaskie
    • Wrocław, Dolnoslaskie, Poland, 51-162
      • Recruiting
      • Centrum Badan Klinicznych Piotr Napora Lekarze Spolka Partnerska
  • Lodzkie
    • Łódź, Lodzkie, Poland, 91-463
      • Recruiting
      • Centrum Medyczne PROFAMILIA
  • Lubelskie
    • Świdnik, Lubelskie, Poland, 21-040
      • Recruiting
      • NZOZ IGNIS dr med. Alicja Lobinska
  • Malopolskie
    • Tarnów, Malopolskie, Poland, 33-100
      • Recruiting
      • ALERGO-MED Specjalistyczna Przychodnia Lekarska Sp. z.o.o
  • Wielkopolskie
    • Poznań, Wielkopolskie, Poland, 60-309
      • Recruiting
      • EMC Instytut Medyczny S.A.PL CERTUS Szpital i Ambulatorium
• Puerto Rico
  • San Juan, Puerto Rico, 00918
    • Recruiting
    • Caribbean Medical Research Center
• Slovakia
  • Bardejov, Slovakia, 085 01
    • Recruiting
    • ALIAN, s.r.o
  • Spišská Nová Ves, Slovakia, 052 01
    • Recruiting
    • Plucna ambulancia Hrebenar, s.r.o.
• South Africa
  • Cape Town, South Africa, 7530
    • Recruiting
    • Tiervlei Trial Centre-43 Old Oak Road
  • Johannesburg, South Africa, 2001
    • Recruiting
    • Newtown Clinical Research Centre
  • Paarl, South Africa, 7646
    • Recruiting
    • Be Part Yoluntu Centre
  • Pretoria, South Africa
    • Recruiting
    • Clinical Trial Systems
  • Mpumalanga
    • Kwamhlanga, Mpumalanga, South Africa, 1022
      • Recruiting
      • Zinakekele Medical Centre
• Spain
  • Alicante, Spain, 03010
    • Recruiting
    • Hospital General Universitario Dr. Balmis
  • Barcelona, Spain, 08023
    • Recruiting
    • Hospital Hm Nou Delfos
  • Santiago De Compostela, Spain, 15706
    • Recruiting
    • CHUS - H. Clinico U. de Santiago
  • Cordoba
    • Cabra, Cordoba, Spain, 14940
      • Recruiting
      • Centro de salud Cabra Matrona Antonia Mesa Fernández
  • Malaga
    • Marbella, Malaga, Spain, 29600
      • Recruiting
      • Hospital Costa del Sol
• Taiwan
  • Kaohsiung City, Taiwan, 807
    • Recruiting
    • Kaohsiung Medical University - Chung-Ho Memorial Hospital
  • Taipei, Taiwan
    • Recruiting
    • National Taiwan University Hospital
  • Taipei, Taiwan, 11490
    • Recruiting
    • Tri-Service General Hospital
  • Taipei, Taiwan, 116
    • Recruiting
    • Taipei Municipal Wanfang Hospital
• United States
  • Alabama
    • Huntsville, Alabama, United States, 35801
      • Recruiting
      • Longwood Research
  • Arizona
    • Tempe, Arizona, United States, 85282-2455
      • Recruiting
      • Voyage Medical
  • California
    • Fullerton, California, United States, 92835-3424
      • Recruiting
      • Ascada Research LLC
    • Lomita, California, United States, 90717
      • Recruiting
      • Torrance Clinical Research Institute
    • Los Angeles, California, United States, 90017
      • Recruiting
      • Downtown LA Research Center Inc - ClinEdge - PPDS
    • Roseville, California, United States, 95678-2474
      • Recruiting
      • Capitis Medical And Aesthetics
    • San Bernardino, California, United States, 92408-3406
      • Recruiting
      • CRMD Research LLC
    • Westlake, California, United States, 90057
      • Recruiting
      • Velocity Clinical Research
    • Westminster, California, United States, 92683
      • Recruiting
      • Allianz Research Institute Inc
  • Colorado
    • Denver, Colorado, United States, 80219
      • Recruiting
      • Allianz Research Institute
  • Florida
    • Cape Coral, Florida, United States, 33990
      • Recruiting
      • C&A Clinical Trials Corp
    • Cutler Bay, Florida, United States, 33157
      • Recruiting
      • Beautiful Minds Clinical Research Center
    • Kissimmee, Florida, United States, 34741
      • Recruiting
      • I.H.S Health LLC
    • Miami, Florida, United States, 33014
      • Recruiting
      • San Marcus Research Clinic Inc
    • Miami, Florida, United States, 33144
      • Recruiting
      • Dynamic Medical Research, LLC
    • Miami, Florida, United States, 33179-2537
      • Recruiting
      • Floridian Research Institute
    • Miami Lakes, Florida, United States, 33014-2406
      • Recruiting
      • Myrak Research Center Inc.
    • Orlando, Florida, United States, 32825
      • Recruiting
      • Florida Institute For Clinical Research LLC
    • Ormond Beach, Florida, United States, 32174
      • Recruiting
      • Ormond Beach Clinical Research
    • Tampa, Florida, United States, 33615
      • Recruiting
      • Santos Research Center
  • Georgia
    • Columbus, Georgia, United States, 31909-1723
      • Recruiting
      • Acute Care Emergence
    • East Point, Georgia, United States, 30344
      • Recruiting
      • Covenant Pulmonary Criticial Care and Research Ins
  • Indiana
    • Evansville, Indiana, United States, 47712
      • Recruiting
      • Medisphere Medical Research Center LLC
    • Mishawaka, Indiana, United States, 46545
      • Recruiting
      • Del Pilar Medical and Urgent Care
  • Louisiana
    • Lafayette, Louisiana, United States, 70508
      • Recruiting
      • Velocity Clinical Research - Covington - PPDS
  • Michigan
    • Madison Heights, Michigan, United States, 48071
      • Recruiting
      • Medical Arts Research Center
  • Mississippi
    • Gulfport, Mississippi, United States, 39503
      • Recruiting
      • Velocity Clinical Research - Gulfport - PPDS
    • Vicksburg, Mississippi, United States, 39183-4408
      • Recruiting
      • Safe Haven Clinical Research
  • Montana
    • Butte, Montana, United States, 59701
      • Recruiting
      • Mercury Street Medical
  • Nebraska
    • Bellevue, Nebraska, United States, 68046
      • Recruiting
      • Nebraska Medical Research Institute, Inc
  • Nevada
    • Las Vegas, Nevada, United States, 89121
      • Recruiting
      • Clinical Research of South Nevada - Clinedge - PPDS
  • New Jersey
    • Old Bridge, New Jersey, United States, 08857
      • Recruiting
      • Raritan Bay Primary Care & Cardiology Associates
  • North Carolina
    • Morganton, North Carolina, United States, 28655
      • Recruiting
      • Burke Primary Care
    • Winston-Salem, North Carolina, United States, 27103
      • Recruiting
      • Progressive Medicine of the Triad, LLC
  • Ohio
    • Toledo, Ohio, United States, 43617
      • Recruiting
      • Toledo Institute of Clinical Research
  • South Carolina
    • Little River, South Carolina, United States, 29566
      • Recruiting
      • Main Street Physicians Care
    • Spartanburg, South Carolina, United States, 29303
      • Recruiting
      • Spartanburg Medical Research
  • Tennessee
    • Chattanooga, Tennessee, United States, 37421-1651
      • Recruiting
      • ClinSearch, LLC - M3 WR
  • Texas
    • Austin, Texas, United States, 78704-7507
      • Recruiting
      • Accelemed Research Institute
    • Baytown, Texas, United States, 77521
      • Recruiting
      • Inquest Clinical Research
    • Fort Worth, Texas, United States, 76164-9041
      • Recruiting
      • Valley Institute of Research
    • Houston, Texas, United States, 77022
      • Recruiting
      • HDH Research, Inc.
    • McKinney, Texas, United States, 75069
      • Recruiting
      • Metroplex Pulmonary and Sleep Medicine Center-4833 Medical Center Dr Unit 6B
    • Mesquite, Texas, United States, 75149
      • Recruiting
      • SMS Clinical Research, LLC

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 (Estimated): April 1, 2024
• Study Completion (Estimated): April 1, 2024

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 (Actual): September 13, 2023
• Last Update Submitted That Met QC Criteria: September 12, 2023
• Last Verified: October 1, 2022

More Information

Terms related to this study

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

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