A Study of EDP-938 in Non-hospitalized Adults With RSV Who Are at High Risk for Complications.
- Registration Number
- NCT05568706
- Lead Sponsor
- Enanta Pharmaceuticals, Inc
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 180
-
At least one of the following conditions that predispose them to complications after RSV infection:
- Age ≥65 years
- Congestive heart failure (CHF)
- Asthma
- 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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Matching placebo, once daily EDP-938 EDP-938 EDP-938 800 mg, once daily
- Primary Outcome Measures
Name Time Method Time to resolution of RSV Lower Respiratory Tract Disease (LRTD) symptoms Day 1 through Day 33
- Secondary Outcome Measures
Name Time Method Time to resolution of LRTD symptoms and 2 systemic symptoms Day 1 through Day 33 Time to resolution of Upper Respiratory Tract Disease congestion), LRTD, and 2 systemic symptoms Day 1 through Day 33 Change from Baseline in severity of RSV LRTD symptoms Day 1 through Day 33 Time to return to usual health Day 1 through Day 33 Time to resolution of all RSV symptoms Day 1 through Day 33 Change from Baseline for impact scale Day 1 through Day 33 Change from Baseline for Health-Related Quality of Life Day 1 through Day 33 Percentage of subjects requiring hospitalization for RSV or other causes; Day 1 through Day 33 All-cause mortality Day 1 through Day 33 Change in infectious RSV viral load over time Up to Day 14 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 Safety as measured by frequency of adverse events (AEs) Up to Day 33 Time to return to usual activities Day 1 through Day 33 Duration of hospitalization for RSV or other causes Day 1 through Day 33 RSV RNA viral load change from Baseline Days 3, 5, 9, and 14 Plasma PK Concentrations of EDP-938 Up to Day 5
Trial Locations
- Locations (165)
Voyage Medical
🇺🇸Tempe, Arizona, United States
Instituto de Medicina Respiratoria, IMeR
🇦🇷Córdoba, Argentina
Instituto Del Buen Aire
🇦🇷Santa Fe, Argentina
L2 Ip - Instituto de Pesquisas Clinicas Ltda - ME
🇧🇷Brasília, Distrito Federal, Brazil
INSARES
🇦🇷Mendoza, Argentina
Medical Center Hera - Kyustendil EOOD
🇧🇬Kyustendil, Bulgaria
Medical Center Hera EOOD, Montana
🇧🇬Montana, Bulgaria
Specialized Hospital for Active Treatment of Pulmonary Diseases- Pernik EOOD
🇧🇬Pernik, Bulgaria
Medical Center Prolet EOOD
🇧🇬Ruse, Bulgaria
Medical Center Hipocrena
🇧🇬Sevlievo, Bulgaria
Medical Center Hera EOOD
🇧🇬Sofia, Bulgaria
Medical Center Neuromedix EOOD
🇧🇬Veliko Tarnovo, Bulgaria
Servicios de Salud IPS Suramericana S.A.S. - IPS Sura Industriales Medellin
🇨🇴Medellín, Antioquia, Colombia
Taipei Municipal Wanfang Hospital
🇨🇳Taipei, Taiwan
Longwood Research
🇺🇸Huntsville, Alabama, United States
UCSF Fresno
🇺🇸Fresno, California, United States
Ascada Research LLC
🇺🇸Fullerton, California, United States
Torrance Clinical Research Institute
🇺🇸Lomita, California, United States
Downtown LA Research Center Inc - ClinEdge - PPDS
🇺🇸Los Angeles, California, United States
Velocity Clinical Research
🇺🇸Los Angeles, California, United States
Capitis Medical And Aesthetics
🇺🇸Roseville, California, United States
CRMD Research LLC
🇺🇸San Bernardino, 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
Myrak Research Center Inc.
🇺🇸Miami Lakes, Florida, United States
Palm Springs Community Health Center
🇺🇸Miami Lakes, Florida, United States
San Marcus Research Clinic Inc
🇺🇸Miami, Florida, United States
Optimus U Corp
🇺🇸Miami, Florida, United States
Dynamic Medical Research, LLC
🇺🇸Miami, Florida, United States
Floridian Research Institute
🇺🇸Miami, Florida, United States
Florida Institute For Clinical Research LLC
🇺🇸Orlando, 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
Columbus Regional Research Institute - Centricity - PPDS
🇺🇸Columbus, Georgia, United States
Covenant Pulmonary Criticial Care and Research Ins
🇺🇸East Point, Georgia, United States
Southeast Lung Associates Research
🇺🇸Rincon, Georgia, United States
Snake River Research
🇺🇸Idaho Falls, Idaho, United States
Medisphere Medical Research Center LLC
🇺🇸Evansville, Indiana, United States
Del Pilar Medical and Urgent Care
🇺🇸Mishawaka, Indiana, United States
University of Louisville
🇺🇸Louisville, Kentucky, United States
Velocity Clinical Research - Covington - PPDS
🇺🇸Lafayette, Louisiana, United States
Medical Arts Research Center
🇺🇸Madison Heights, Michigan, United States
Velocity Clinical Research - Gulfport - PPDS
🇺🇸Gulf Port, Mississippi, United States
Safe Haven Clinical Research
🇺🇸Vicksburg, Mississippi, United States
Mercury Street Medical
🇺🇸Butte, Montana, United States
Nebraska Medical Research Institute, Inc
🇺🇸Bellevue, Nebraska, United States
Clinical Research of South Nevada - Clinedge - PPDS
🇺🇸Las Vegas, Nevada, United States
Raritan Bay Primary Care & Cardiology Associates
🇺🇸Old Bridge, New Jersey, United States
Global Health Institute
🇺🇸Syracuse, New York, United States
Burke Primary Care
🇺🇸Morganton, North Carolina, United States
Progressive Medicine of the Triad, LLC
🇺🇸Winston-Salem, North Carolina, United States
Helios CR, Inc. - Cleveland - PPDS
🇺🇸Middleburg Heights, Ohio, United States
Toledo Institute of Clinical Research
🇺🇸Toledo, Ohio, United States
Main Street Physicians Care
🇺🇸Little River, South Carolina, United States
Spartanburg Medical Research
🇺🇸Spartanburg, South Carolina, United States
ClinSearch, LLC - M3 WR
🇺🇸Chattanooga, Tennessee, United States
Helios CR, Inc. - Stonecreek Circle - Jackson - PPDS
🇺🇸Jackson, Tennessee, United States
IMA Clinical Research - Austin - PPDS
🇺🇸Austin, Texas, United States
Inquest Clinical Research
🇺🇸Baytown, Texas, United States
Global Medical Research
🇺🇸Dallas, Texas, United States
GLRI El Paso Research
🇺🇸El Paso, Texas, United States
Valley Institute of Research
🇺🇸Fort Worth, Texas, United States
HDH Research, Inc.
🇺🇸Houston, Texas, United States
Aqua Research Institute, LLC
🇺🇸Houston, Texas, United States
Sacred Ground Research
🇺🇸Humble, 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
Olympus Clinical Research, LLC
🇺🇸Sugar Land, Texas, United States
Eastside Research Associates
🇺🇸Redmond, Washington, United States
Instituto De Enfermedades Respiratorias E Investigacion Medica
🇦🇷Florencio Varela, Buenos Aires, Argentina
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
🇦🇷Ciudad Autónoma de Buenos Aires, Ciudad Autónoma de BuenosAires, Argentina
Instituto Médico Río Cuarto
🇦🇷Río Cuarto, Cordoba, Argentina
Centro de Investigaciones Médicas Tucumán
🇦🇷San Miguel De Tucumán, San Miguel, Argentina
Instituto Médico de la Fundación Estudios Clínicos
🇦🇷Rosario, Santa Fe, Argentina
Instituto De Patologías Respiratorias
🇦🇷San Miguel de Tucumán, Tucumán, Argentina
Clinica Mayo de U.M.C.B. S.R.L
🇦🇷San Miguel De Tucumán, Tucumán, Argentina
CINME S.A. - Centro de Investigaciones Metabólicas - Rx Trials LLC
🇦🇷Buenos Aires, Argentina
DASA - Complexo Hospitalar de Niteroi - PPDS
🇧🇷Niteroi, Rio de Janeiro, Brazil
Hospital de Clinicas de Porto Alegre (HCPA) - PPDS
🇧🇷Porto Alegre, Rio Grande do Sul, Brazil
Instituto D'Or Pesquisa e Ensino - Hospital Glória D´Or
🇧🇷Rio De Janeiro, Brazil
IBPCLIN Instituto Brasil de Pesquisa Clínica
🇧🇷Rio De Janeiro, Brazil
CPCLIN Centro de Pesquisas Clínicas Ltda
🇧🇷Sao Paulo, Brazil
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
🇧🇷São Paulo, Brazil
Diagnostic Consultative Center-1-Sevlievo EOOD
🇧🇬Sevlievo, Gabrovo, Bulgaria
Specialized Hospital for Active Treatment of Pulmonary Diseases
🇧🇬Troyan, Lovech, Bulgaria
Diagnostic Consultative Center 1- Lom EOOD
🇧🇬Lom, Montana, Bulgaria
Medical Center Medconsult Pleven OOD
🇧🇬Pleven, Plevan, Bulgaria
Medical Center Sanador M EOOD
🇧🇬Sofia, Sofia Grad, Bulgaria
Multiprofile Hospital for Active Treatment Puls AD - PPDS
🇧🇬Blagoevgrad, Bulgaria
Medical Center For Life EOOD
🇧🇬Burgas, Bulgaria
Specialized Hospital for Active Treatment of Pneumophthisiatric Diseases - Haskovo EOOD
🇧🇬Haskovo, Bulgaria
Medical Center Zdrave-1 OOD
🇧🇬Kozloduy, Bulgaria
University Multiprofile Hospital for Active Treatment Sofiamed OOD
🇧🇬Sofia, Bulgaria
Medical Centre Pratia Clinic EOOD Varna
🇧🇬Varna, Bulgaria
Medical Center Tara OOD
🇧🇬Veliko Tarnovo, Bulgaria
Clinica de la Costa Ltda - PPDS
🇨🇴Barranquilla, Atlántico, Colombia
Clínica Universidad De la Sabana
🇨🇴Chia, Cundinamarca, Colombia
Fundacion Centro de Investigaciones Clinicas IPS Cardiomet Pereira
🇨🇴Pereira, Risaralda, Colombia
Oinsamed S.A.S - Clinica Misericordia
🇨🇴Barranquilla, Colombia
Fundacion Centro de Investigacion Clinica CIC
🇨🇴Medellín, Colombia
MediTrial s.r.o.
🇨🇿Jindřichův Hradec, Jihoceský kraj, Czechia
Praktický lékar Všestary s.r.o
🇨🇿Všestary, Královéhradecký kraj, Czechia
MUDr. Jakub Strincl, s.r.o.
🇨🇿Liberec, Liberecký kraj, Czechia
Progerint s.r.o.
🇨🇿Vysoké Mýto, Pardubický kraj, Czechia
Res Medica s.r.o.
🇨🇿Nový Knín, Czechia
MEDISON, s.r.o.
🇨🇿Přeštice, Czechia
Ordinace Hradební s.r.o.
🇨🇿České Budějovice, Czechia
Clalit HMO - Atlit
🇮🇱Atlit, Haifa, Israel
Matan Clinic Clalit
🇮🇱Matan, HaMerkaz, Israel
Sultan Ahmad Shah Medical Centre at IIUM
🇲🇾Kuantan, Pahang, Malaysia
Hospital Miri
🇲🇾Miri, Sarawak, Malaysia
Centro de Atención e Investigación Médica S.A. - México - CAIMED - PPDS
🇲🇽Ciudad de México, Distrito Federal, Mexico
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
Accelerium, S. de R.L. de C.V. - PPDS
🇲🇽Monterrey, Nuevo León, Mexico
Camacho Ortiz, Adrian
🇲🇽Monterrey, Nuevo León, Mexico
Oaxaca Site Management Organization - Clinic - OSMO - PPDS
🇲🇽Oaxaca de Juarez, Mexico
Centro de Alta Especialidad Dr. Rafael Lucio
🇲🇽Veracruz, Mexico
FAICIC
🇲🇽Veracruz, Mexico
Huisartsenpraktijk Broekman
🇳🇱Rotterdam, Zuid-Holland, Netherlands
Office of Dr Mangal
🇳🇱Rotterdam, Zuid-Holland, Netherlands
Office of Dr van Soerland
🇳🇱Rotterdam, Zuid-Holland, Netherlands
Office of Dr Verkleij
🇳🇱Rotterdam, Zuid-Holland, Netherlands
Qclinical B.V.
🇳🇱Rotterdam, Zuid-Holland, Netherlands
Office of Dr Rambharose
🇳🇱Rotterdam, Zuid-Holland, Netherlands
Healthlink Medicalsurgicaldental Clinic and Diagnostic Center
🇵🇭Iloilo City, Iloilo, Philippines
Chinese Gen. Hospital and MC
🇵🇭Manila City, Philippines
Centrum Badan Klinicznych Piotr Napora Lekarze Spolka Partnerska
🇵🇱Wrocław, Dolnoslaskie, Poland
Centrum Medyczne PROFAMILIA
🇵🇱Łódź, Lodzkie, Poland
NZOZ IGNIS dr med. Alicja Lobinska
🇵🇱Świdnik, Lubelskie, Poland
Alergo-Med Specjalistyczna Przychodnia Lekarska Sp. z.o.o
🇵🇱Tarnów, Malopolskie, Poland
EMC Instytut Medyczny S.A.PL CERTUS Szpital i Ambulatorium
🇵🇱Poznań, Wielkopolskie, Poland
Specjalistyczny Osrodek Leczniczo-Badawczy Zbigniew Zegota
🇵🇱Ostróda, Poland
PULMAG Grzegorz Gasior Marzena Kociolek Spolka Cywilna
🇵🇱Sosnowiec, Poland
Caribbean Medical Research Center
🇵🇷San Juan, Puerto Rico
ALIAN, s.r.o
🇸🇰Bardejov, Slovakia
Plucna ambulancia Hrebenar, s.r.o.
🇸🇰Spišská Nová Ves, Slovakia
Enhancing Care Foundation
🇿🇦Durban, Kwazulu-Natal, South Africa
Zinakekele Medical Centre
🇿🇦Kwamhlanga, Mpumalanga, South Africa
Tiervlei Trial Centre-43 Old Oak Road
🇿🇦Cape Town, South Africa
Newtown Clinical Research Centre
🇿🇦Johannesburg, South Africa
Be Part Yoluntu Centre
🇿🇦Paarl, South Africa
Clinical Trial Systems
🇿🇦Pretoria, South Africa
Centro de salud Cabra Matrona Antonia Mesa Fernández
🇪🇸Cabra, Cordoba, Spain
Hospital Costa del Sol
🇪🇸Marbella, Malaga, Spain
Hospital General Universitario Dr. Balmis
🇪🇸Alicante, Spain
Hospital HM Nou Delfos
🇪🇸Barcelona, Spain
CHUS - H. Clinico U. de Santiago
🇪🇸Santiago De Compostela, Spain
Kaohsiung Medical University - Chung-Ho Memorial Hospital
🇨🇳Kaohsiung City, Taiwan
Taichung Veterans General Hospital
🇨🇳Taichung, Taiwan
Tri-Service General Hospital
🇨🇳Taipei, Taiwan
National Taiwan University Hospital
🇨🇳Taipei, Taiwan