Phase
Condition
Respiratory Syncytial Virus (Rsv) Infection
Respiratory Syncytial Virus (Rsv)
Treatment
Placebo
EDP-938
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- At least one of the following conditions that predispose them to complications afterRSV 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 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
Connect with a study center
Instituto De Enfermedades Respiratorias E Investigacion Medica
Florencio Varela, Buenos Aires 1888
ArgentinaSite Not Available
Instituto De Enfermedades Respiratorias E Investigacion Medica
Florencio Varela, Buenos Aires 1888
ArgentinaSite Not Available
Instituto Medico Platense
La Plata, Buenos Aires 1900
ArgentinaActive - Recruiting
Centro de Investigaciones Medica Mar del Plata
Mar Del Plata, Buenos Aires B7600FYK
ArgentinaActive - Recruiting
Clinica Privada Independencia
Munro, Buenos Aires B1605
ArgentinaActive - Recruiting
Consultorios Médicos Dr. Doreski
Ciudad Autónoma de Buenos Aires, Ciudad Autónoma de BuenosAires C1426ABP
ArgentinaActive - Recruiting
Instituto Médico Río Cuarto
Río Cuarto, Cordoba 5800
ArgentinaActive - Recruiting
Centro de Investigaciones Médicas Tucumán
San Miguel De Tucumán, San Miguel T4000AXL
ArgentinaSite Not Available
Instituto Médico de la Fundación Estudios Clínicos
Rosario, Santa Fe S2013DTC
ArgentinaSite Not Available
Clinica Mayo de U.M.C.B. S.R.L
San Miguel De Tucumán, Tucumán T4000NWB
ArgentinaActive - Recruiting
Instituto De Patologías Respiratorias
San Miguel de Tucumán, Tucumán 4000
ArgentinaSite Not Available
CINME S.A. - Centro de Investigaciones Metabólicas - Rx Trials LLC
Buenos Aires, C1221ABL
ArgentinaSite Not Available
Instituto de Medicina Respiratoria, IMeR
Córdoba, X5000DCE
ArgentinaSite Not Available
INSARES
Mendoza, M5500CCG
ArgentinaSite Not Available
Instituto Del Buen Aire
Santa Fe, 3000
ArgentinaActive - Recruiting
L2 Ip - Instituto de Pesquisas Clinicas Ltda - ME
Brasília, Distrito Federal 70200-715
BrazilSite Not Available
Hospital de Clinicas de Porto Alegre (HCPA) - PPDS
Porto Alegre, Rio Grande do Sul 90035-001
BrazilSite Not Available
DASA - Complexo Hospitalar de Niteroi - PPDS
Niteroi, Rio de Janeiro 24020-096
BrazilSite Not Available
IBPCLIN Instituto Brasil de Pesquisa Clínica
Rio De Janeiro, 22271-100
BrazilSite Not Available
Instituto D'Or Pesquisa e Ensino - Hospital Glória D´Or
Rio De Janeiro, 21040-360
BrazilSite Not Available
CPCLIN Centro de Pesquisas Clínicas Ltda
Sao Paulo,
BrazilSite Not Available
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
São Paulo, 05403-000
BrazilSite Not Available
Diagnostic Consultative Center-1-Sevlievo EOOD
Sevlievo, Gabrovo 5400
BulgariaActive - Recruiting
Specialized Hospital for Active Treatment of Pulmonary Diseases
Troyan, Lovech 5600
BulgariaActive - Recruiting
Diagnostic Consultative Center 1- Lom EOOD
Lom, Montana 3600
BulgariaActive - Recruiting
Medical Center Medconsult Pleven OOD
Pleven, Plevan 5800
BulgariaSite Not Available
Medical Center Sanador M EOOD
Sofia, Sofia Grad 1431
BulgariaActive - Recruiting
Multiprofile Hospital for Active Treatment Puls AD - PPDS
Blagoevgrad, 2700
BulgariaActive - Recruiting
Medical Center For Life EOOD
Burgas, 8000
BulgariaActive - Recruiting
Specialized Hospital for Active Treatment of Pneumophthisiatric Diseases - Haskovo EOOD
Haskovo, 6305
BulgariaActive - Recruiting
Medical Center Zdrave-1 OOD
Kozloduy, 3320
BulgariaActive - Recruiting
Medical Center Hera - Kyustendil EOOD
Kyustendil, 2500
BulgariaActive - Recruiting
Medical Center Hera EOOD, Montana
Montana, 3400
BulgariaActive - Recruiting
Specialized Hospital for Active Treatment of Pulmonary Diseases- Pernik EOOD
Pernik, 2300
BulgariaActive - Recruiting
Medical Center Prolet EOOD
Ruse, 7002
BulgariaActive - Recruiting
Medical Center Hipocrena
Sevlievo, 5400
BulgariaActive - Recruiting
Medical Center Hera EOOD
Sofia, 1202
BulgariaActive - Recruiting
University Multiprofile Hospital for Active Treatment Sofiamed OOD
Sofia, 1750
BulgariaActive - Recruiting
Medical Center Leo Clinic EOOD, Varna
Varna,
BulgariaActive - Recruiting
Medical Centre Pratia Clinic EOOD Varna
Varna,
BulgariaActive - Recruiting
Medical Center Neuromedix EOOD
Veliko Tarnovo, 5006
BulgariaActive - Recruiting
Medical Center Tara OOD
Veliko Tarnovo, 5000
BulgariaActive - Recruiting
Servicios de Salud IPS Suramericana S.A.S. - IPS Sura Industriales Medellin
Medellín, Antioquia 50021
ColombiaActive - Recruiting
Clinica de la Costa Ltda - PPDS
Barranquilla, Atlántico 080020
ColombiaActive - Recruiting
Clínica Universidad De la Sabana
Chia, Cundinamarca 250001
ColombiaActive - Recruiting
Fundacion Centro de Investigaciones Clinicas IPS Cardiomet Pereira
Pereira, Risaralda 660003
ColombiaActive - Recruiting
Oinsamed S.A.S - Clinica Misericordia
Barranquilla, 080020
ColombiaActive - Recruiting
Fundacion Centro de Investigacion Clinica CIC
Medellín, 050021
ColombiaActive - Recruiting
MediTrial s.r.o.
Jindřichův Hradec, Jihoceský kraj 377 01
CzechiaSite Not Available
Praktický lékar Všestary s.r.o
Všestary, Královéhradecký kraj 503 12
CzechiaSite Not Available
MUDr. Jakub Strincl, s.r.o.
Liberec, Liberecký kraj 460 14
CzechiaActive - Recruiting
Progerint s.r.o.
Vysoké Mýto, Pardubický kraj 566 01
CzechiaSite Not Available
Res Medica s.r.o.
Nový Knín, 262 03
CzechiaActive - Recruiting
MEDISON, s.r.o.
Přeštice, 334 01
CzechiaSite Not Available
Ordinace Hradební s.r.o.
České Budějovice, 370 01
CzechiaSite Not Available
Matan Clinic Clalit
Matan, HaMerkaz 45858
IsraelSite Not Available
Clalit HMO - Atlit
Atlit, Haifa 30300
IsraelSite Not Available
Sultan Ahmad Shah Medical Centre at IIUM
Kuantan, Pahang 25200
MalaysiaSite Not Available
Hospital Miri
Miri, Sarawak 98000
MalaysiaActive - Recruiting
Centro de Atención e Investigación Médica S.A. - México - CAIMED - PPDS
Ciudad de México, Distrito Federal 06760
MexicoActive - Recruiting
CICUM San Miguel
Guadalajara, Jalisco 44160
MexicoActive - Recruiting
Centro de Investigación Clinica Médica y Farmacoló
Guadalajara, Jalisco 44690
MexicoActive - Recruiting
Hospital Civil Fray Antonio Alcalde
Guadalajara, Jalisco 45235
MexicoActive - Recruiting
Instituto Jalisciense de Investigacion Clinica SA de CV
Guadalajara, Jalisco 44100
MexicoActive - Recruiting
Accelerium, S. de R.L. de C.V. - PPDS
Monterrey, Nuevo León 31000
MexicoActive - Recruiting
Camacho Ortiz, Adrian
Monterrey, Nuevo León
MexicoActive - Recruiting
Oaxaca Site Management Organization - Clinic - OSMO - PPDS
Oaxaca de Juarez, 68000
MexicoActive - Recruiting
Centro de Alta Especialidad Dr. Rafael Lucio
Veracruz, 91020
MexicoActive - Recruiting
FAICIC
Veracruz, 91700
MexicoActive - Recruiting
Huisartsenpraktijk Broekman
Rotterdam, Zuid-Holland 3051 GV
NetherlandsSite Not Available
Office of Dr Mangal
Rotterdam, Zuid-Holland 3051 GV
NetherlandsSite Not Available
Office of Dr Rambharose
Rotterdam, Zuid-Holland 3051-GV
NetherlandsSite Not Available
Office of Dr Verkleij
Rotterdam, Zuid-Holland 3051 GV
NetherlandsSite Not Available
Office of Dr van Soerland
Rotterdam, Zuid-Holland 3051 GV
NetherlandsSite Not Available
Qclinical B.V.
Rotterdam, Zuid-Holland 3051 GV
NetherlandsSite Not Available
Healthlink Medicalsurgicaldental Clinic and Diagnostic Center
Iloilo City, Iloilo 5000
PhilippinesSite Not Available
Chinese Gen. Hospital and MC
Manila City, 1014
PhilippinesSite Not Available
Centrum Badan Klinicznych Piotr Napora Lekarze Spolka Partnerska
Wrocław, Dolnoslaskie 51-162
PolandSite Not Available
Centrum Medyczne PROFAMILIA
Łódź, Lodzkie 91-463
PolandCompleted
NZOZ IGNIS dr med. Alicja Lobinska
Świdnik, Lubelskie 21-040
PolandSite Not Available
Alergo-Med Specjalistyczna Przychodnia Lekarska Sp. z.o.o
Tarnów, Malopolskie 33-100
PolandSite Not Available
EMC Instytut Medyczny S.A.PL CERTUS Szpital i Ambulatorium
Poznań, Wielkopolskie 60-309
PolandSite Not Available
Specjalistyczny Osrodek Leczniczo-Badawczy Zbigniew Zegota
Ostróda, 14-100
PolandSite Not Available
PULMAG Grzegorz Gasior Marzena Kociolek Spolka Cywilna
Sosnowiec, 41-208
PolandSite Not Available
Caribbean Medical Research Center
San Juan, 00918
Puerto RicoSite Not Available
ALIAN, s.r.o
Bardejov, 085 01
SlovakiaSite Not Available
Plucna ambulancia Hrebenar, s.r.o.
Spišská Nová Ves, 052 01
SlovakiaActive - Recruiting
Enhancing Care Foundation
Durban, Kwazulu-Natal 4319
South AfricaSite Not Available
Zinakekele Medical Centre
Kwamhlanga, Mpumalanga 1022
South AfricaSite Not Available
Tiervlei Trial Centre-43 Old Oak Road
Cape Town, 7530
South AfricaSite Not Available
Newtown Clinical Research Centre
Johannesburg, 2001
South AfricaCompleted
Be Part Yoluntu Centre
Paarl, 7646
South AfricaCompleted
Clinical Trial Systems
Pretoria,
South AfricaSite Not Available
Centro de salud Cabra Matrona Antonia Mesa Fernández
Cabra, Cordoba 14940
SpainActive - Recruiting
Hospital Costa del Sol
Marbella, Malaga 29600
SpainSite Not Available
Hospital General Universitario Dr. Balmis
Alicante, 03010
SpainActive - Recruiting
Hospital HM Nou Delfos
Barcelona, 08023
SpainSite Not Available
CHUS - H. Clinico U. de Santiago
Santiago De Compostela, 15706
SpainActive - Recruiting
Kaohsiung Medical University - Chung-Ho Memorial Hospital
Kaohsiung City, 807
TaiwanSite Not Available
Taichung Veterans General Hospital
Taichung, 40705
TaiwanCompleted
National Taiwan University Hospital
Taipei,
TaiwanSite Not Available
Taipei Municipal Wanfang Hospital
Taipei, 116
TaiwanSite Not Available
Tri-Service General Hospital
Taipei, 11490
TaiwanCompleted
Longwood Research
Huntsville, Alabama 35801
United StatesSite Not Available
Voyage Medical
Tempe, Arizona 85282-2455
United StatesCompleted
UCSF Fresno
Fresno, California 93701
United StatesCompleted
Ascada Research LLC
Fullerton, California 92835-3424
United StatesSite Not Available
Torrance Clinical Research Institute
Lomita, California 90717
United StatesCompleted
Downtown LA Research Center Inc - ClinEdge - PPDS
Los Angeles, California 90017
United StatesActive - Recruiting
Velocity Clinical Research
Los Angeles, California 90057
United StatesSite Not Available
Capitis Medical And Aesthetics
Roseville, California 95678-2474
United StatesSite Not Available
CRMD Research LLC
San Bernardino, California 92408-3406
United StatesSite Not Available
Velocity Clinical Research
Westlake, California 90057
United StatesSite Not Available
Allianz Research Institute Inc
Westminster, California 92683
United StatesCompleted
Allianz Research Institute - Colorado
Aurora, Colorado 80014
United StatesCompleted
Allianz Research Institute
Denver, Colorado 80219
United StatesSite Not Available
Bay Pines VA Healthcare System
Bay Pines, Florida 33744
United StatesActive - Recruiting
C&A Clinical Trials Corp
Cape Coral, Florida 33990
United StatesActive - Recruiting
Beautiful Minds Clinical Research Center
Cutler Bay, Florida 33157
United StatesActive - Recruiting
Dinamo Research & Diagnostic center, LLC
Hialeah, Florida 33015
United StatesActive - Recruiting
I.H.S Health LLC
Kissimmee, Florida 34741
United StatesTerminated
Dynamic Medical Research, LLC
Miami, Florida 33144
United StatesActive - Recruiting
Floridian Research Institute
Miami, Florida 33179-2537
United StatesActive - Recruiting
Optimus U Corp
Miami, Florida 33135
United StatesSite Not Available
San Marcus Research Clinic Inc
Miami, Florida 33014
United StatesSite Not Available
Myrak Research Center Inc.
Miami Lakes, Florida 33014-2406
United StatesSite Not Available
Palm Springs Community Health Center
Miami Lakes, Florida 33014
United StatesSite Not Available
Florida Institute For Clinical Research LLC
Orlando, Florida 32825
United StatesSite Not Available
Orlando VA Healthcare System
Orlando, Florida 32827
United StatesActive - Recruiting
Ormond Beach Clinical Research
Ormond Beach, Florida 32174
United StatesCompleted
CDC Research Institute, LLC
Port Saint Lucie, Florida 34952
United StatesActive - Recruiting
Research Bay, Inc.
Tampa, Florida 33607
United StatesActive - Recruiting
Santos Research Center
Tampa, Florida 33615
United StatesActive - Recruiting
Acute Care Emergence
Columbus, Georgia 31909-1723
United StatesActive - Recruiting
Columbus Regional Research Institute - Centricity - PPDS
Columbus, Georgia 31909-1723
United StatesSite Not Available
Covenant Pulmonary Criticial Care and Research Ins
East Point, Georgia 30344
United StatesActive - Recruiting
Southeast Lung Associates Research
Rincon, Georgia 31326
United StatesSite Not Available
Snake River Research
Idaho Falls, Idaho 83404
United StatesActive - Recruiting
Medisphere Medical Research Center LLC
Evansville, Indiana 47712
United StatesSite Not Available
Del Pilar Medical and Urgent Care
Mishawaka, Indiana 46545
United StatesSite Not Available
University of Louisville
Louisville, Kentucky 40202
United StatesActive - Recruiting
Velocity Clinical Research - Covington - PPDS
Lafayette, Louisiana 70508
United StatesSite Not Available
Medical Arts Research Center
Madison Heights, Michigan 48071
United StatesSite Not Available
Velocity Clinical Research - Gulfport - PPDS
Gulf Port, Mississippi 39503
United StatesSite Not Available
Velocity Clinical Research - Gulfport - PPDS
Gulfport, Mississippi 39503
United StatesSite Not Available
Safe Haven Clinical Research
Vicksburg, Mississippi 39183-4408
United StatesSite Not Available
Mercury Street Medical
Butte, Montana 59701
United StatesCompleted
Nebraska Medical Research Institute, Inc
Bellevue, Nebraska 68046
United StatesSite Not Available
Clinical Research of South Nevada - Clinedge - PPDS
Las Vegas, Nevada 89121
United StatesSite Not Available
Raritan Bay Primary Care & Cardiology Associates
Old Bridge, New Jersey 08857
United StatesSite Not Available
Global Health Institute
Syracuse, New York 13210-1685
United StatesActive - Recruiting
Burke Primary Care
Morganton, North Carolina 28655
United StatesSite Not Available
Progressive Medicine of the Triad, LLC
Winston-Salem, North Carolina 27103
United StatesCompleted
Helios CR, Inc. - Cleveland - PPDS
Middleburg Heights, Ohio 44130
United StatesSite Not Available
Toledo Institute of Clinical Research
Toledo, Ohio 43617
United StatesActive - Recruiting
Main Street Physicians Care
Little River, South Carolina 29566
United StatesSite Not Available
Spartanburg Medical Research
Spartanburg, South Carolina 29303
United StatesSite Not Available
ClinSearch, LLC - M3 WR
Chattanooga, Tennessee 37421-1651
United StatesSite Not Available
Helios CR, Inc. - Stonecreek Circle - Jackson - PPDS
Jackson, Tennessee 38305
United StatesSite Not Available
Accelemed Research Institute
Austin, Texas 78704-7507
United StatesActive - Recruiting
IMA Clinical Research - Austin - PPDS
Austin, Texas 78704-7507
United StatesActive - Recruiting
Inquest Clinical Research
Baytown, Texas 77521
United StatesSite Not Available
Global Medical Research
Dallas, Texas 75039
United StatesSite Not Available
GLRI El Paso Research
El Paso, Texas 79936
United StatesSite Not Available
Valley Institute of Research
Fort Worth, Texas 76164-9041
United StatesActive - Recruiting
Aqua Research Institute, LLC
Houston, Texas 77058
United StatesSite Not Available
HDH Research, Inc.
Houston, Texas 77022
United StatesActive - Recruiting
Sacred Ground Research
Humble, Texas 77338
United StatesSite Not Available
Metroplex Pulmonary and Sleep Medicine Center-4833 Medical Center Dr Unit 6B
McKinney, Texas 75069
United StatesActive - Recruiting
SMS Clinical Research, LLC
Mesquite, Texas 75149
United StatesActive - Recruiting
Olympus Clinical Research, LLC
Sugar Land, Texas 77479
United StatesSite Not Available
Eastside Research Associates
Redmond, Washington 98052
United StatesActive - Recruiting
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