Phase
Condition
Respiratory Syncytial Virus (Rsv)
Treatment
Placebo
EDP-938
Clinical Study ID
Ages 28-36 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Male or female who is either ≥6 months to ≤36 months (for Age Group 1) or ≥28 daysto <6 months (for Age Group 2), defined at the time of randomization. Subjects inAge Group 2 must have been born ≥29 weeks of gestation to be eligible.
Subjects diagnosed with RSV infection
Subjects with signs of an acute respiratory illness with onset ≤7 days for Part 1and ≤5 days for Part 2 before the time of signing the ICF
In the Investigator's opinion, the subject's caregiver understands and is able tocomply with protocol requirements, instructions, and protocol-stated restrictions,and the subject is likely to complete the study as planned
Exclusion
Exclusion Criteria:
Use of or anticipated need for invasive mechanical ventilation, cardiopulmonarybypass, hemodialysis, or extracorporeal membrane oxygenation; or subjects who arenot expected to survive the current illness
Underlying immune deficiency, (e.g., from confirmed human immunodeficiency virusinfection or use of an immunosuppressive medication except immunoglobulin Adeficiency)
Receipt of (within 12 months before Screening) or on a waiting list for a bonemarrow, stem cell, or solid organ transplant, or who received radiation orchemotherapy (within 12 months before screening)
Receiving chronic oxygen therapy at home before admission
Subjects whose mother received an investigational RSV vaccination while pregnantwith the subject if they were born at term (≥37 weeks of gestation) and are lessthan 12 months of age
In Part 2, subjects dosed with an investigational or approved medication that isintended to prevent or treat RSV infection within the following times before thefirst dose of study drug: ribavirin 35 days; palivizumab 100 days; nirsevimab 350days; other RSV-specific monoclonal antibody 5 half-lives of the specific antibody;RSV vaccines 12 months.
Study Design
Study Description
Connect with a study center
Clinica del Niño y la Familia
Mar Del Plata, Buenos Aires
ArgentinaSite Not Available
Hospital Interzonal Dr Jose Penna
Bahía Blanca,
ArgentinaSite Not Available
Clínica Privada del Sol
Buenos Aires, C1425
ArgentinaSite Not Available
Instituto Medico Rio Cuarto
Río Cuarto,
ArgentinaSite Not Available
Clinica Central S.A
Villa Regina,
ArgentinaSite Not Available
Sydney Children's Hospital - Randwick
Randwick, New South Wales 2031
AustraliaSite Not Available
The Children's Hospital at Westmead
Westmead, New South Wales 2145
AustraliaSite Not Available
Gold Coast University Hospital
Southport,
AustraliaSite Not Available
Instituto Méderi de Pesquisa e Saúde
Passo Fundo, Rio Grande Do Sul 99010
BrazilSite Not Available
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande Do Sul 90035
BrazilSite Not Available
Irmandade da Santa Casa de Misericórdia Hospital - Porto Alegre
Porto Alegre, Rio Grande Do Sul 90035
BrazilSite Not Available
Universidade Federal do Paraná - Hospital de Clínicas
Curitiba, 80060-900
BrazilSite Not Available
Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto
Ribeirão Preto, 14015-010
BrazilSite Not Available
Universitätsklinikum Gießen und Marburg - Gießen
Marburg, Bundesland 35043
GermanySite Not Available
Universitätsklinikum Erlangen
Erlangen,
GermanySite Not Available
University Hospital Mainz
Mainz,
GermanySite Not Available
Asklepios Klinik Sankt Augustin
Sankt Augustin,
GermanySite Not Available
Soroka University Medical Center
Be'er Sheva,
IsraelSite Not Available
Carmel Medical Center
Haifa,
IsraelSite Not Available
Rambam Health Care
Haifa, 3109601
IsraelSite Not Available
Hadassah University Hospital Mount Scopu
Jerusalem,
IsraelSite Not Available
Schneider Children's Medical Center Of Israel
Petach Tikva, 4920235
IsraelSite Not Available
Inje University Sanggye Paik Hospital
Seoul,
Korea, Republic ofSite Not Available
Kyung Hee University Hospital
Seoul, 2447
Korea, Republic ofSite Not Available
Nowon Eulji Medical Center, Eulji University
Seoul, 1830
Korea, Republic ofSite Not Available
Panamerican Clinical Research Mexico - Guadalajara
Guadalajara, Prados 44670
MexicoSite Not Available
El Cielo Medical Center RSB, S.C.
La Paz, Puebla
MexicoSite Not Available
Hospital Infantil De Mexico Federico Gomez
Mexico City,
MexicoSite Not Available
Instituto Nacional de Pediatría
Mexico City, 04530
MexicoSite Not Available
Karla Adriana Espinosa Bautista
Mexico City,
MexicoSite Not Available
IESCI Clinical Research
Monterrey,
MexicoSite Not Available
PanAmerican Clinical Research
Querétaro,
MexicoSite Not Available
SMIQ S de R.L de C.V
Querétaro,
MexicoSite Not Available
Wellington Regional Hospital
Newtown, Wellington
New ZealandSite Not Available
IN-VIVO Bydgoszcz
Bydgoszcz,
PolandSite Not Available
Wojewódzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Łodzi
Łódź,
PolandSite Not Available
Spital Clinic de Urgenta Pentru Copii Brasov
Braşov, Brașov
RomaniaSite Not Available
Spitalul Clinic Judetean De Urgenta Târgu Mureș
Târgu-Mureş, Târgu Mureș
RomaniaSite Not Available
Institutul National pentru Sanatatea Mamei si Copilului "Alessandrescu-Rusescu"
Bucharest,
RomaniaSite Not Available
Life Westville Hospital
Westville, Durban
South AfricaSite Not Available
Rahima Moosa Mother and Child Hospital
Johannesburg,
South AfricaSite Not Available
Wits Clinical Research
Soweto, 2013
South AfricaSite Not Available
Hospital Germans Trias i Pujol
Barcelona,
SpainSite Not Available
Hospital Universitario Arnau de Vilanova
Lleida,
SpainSite Not Available
Hospital Clínico San Carlos
Madrid,
SpainSite Not Available
Hospital Universitario 12 de Octubre
Madrid,
SpainSite Not Available
Hospital Universitario Fundación Jiménez Díaz
Madrid,
SpainSite Not Available
Hospital Universitario La Paz
Madrid,
SpainSite Not Available
Hospital Universitario Puerta de Hierro - Majadahonda
Madrid,
SpainSite Not Available
Hospital Universitario Quirónsalud Madrid
Madrid,
SpainSite Not Available
Hospital Universitario Severo Ochoa
Madrid,
SpainSite Not Available
Unidad de Ensayos Clínicos Pediátricos
Madrid,
SpainSite Not Available
Hospital Regional Universitario de Málaga
Málaga,
SpainSite Not Available
Hospital Clínico Universitario de Santiago
Santiago De Compostela,
SpainSite Not Available
Hospital Universitario Joan XXIII de Tarragona
Tarragona,
SpainSite Not Available
National Taiwan University Hospital
Taipei city, Taipei 100229
TaiwanSite Not Available
Linkou Chang Gung Memorial Hospital, Chang Gung Medical Foundation
Taoyuan City, Taoyuan 333
TaiwanSite Not Available
Hsinchu Mackay Memorial Hospital
Hsinchu,
TaiwanSite Not Available
Chang Gung Memorial Hospital - Kaohsiung Branch
Kaohsiung,
TaiwanSite Not Available
Chung Shan Medical University Hospital
Taichung,
TaiwanSite Not Available
Taipei Mackay Memorial Hospital
Taipei,
TaiwanSite Not Available
Nottingham University Hospitals NHS Trust
Nottingham, Nottinghamshire NG5 1PB
United KingdomSite Not Available
Alder Hey Children's NHS Foundation Trust
Liverpool,
United KingdomSite Not Available
St. George's University Hospitals NHS Foundation Trust
London, SW17 0QT
United KingdomSite Not Available
Sheffield Children's NHS Foundation Trust
Sheffield,
United KingdomSite Not Available
Memorial Care Miller Children's and Women's Hospital
Long Beach, California 90806
United StatesSite Not Available
University of California Los Angeles (UCLA)
Los Angeles, California 90095
United StatesSite Not Available
UC Davis
Sacramento, California 95817
United StatesSite Not Available
Joe DiMaggio Children's Hospital
Hollywood, Florida 33021
United StatesSite Not Available
University of Florida Health
Jacksonville, Florida 32209
United StatesSite Not Available
Nemours Children's Hospital
Orlando, Florida 32827
United StatesSite Not Available
South Tampa Center for Advanced Healthcare
Tampa, Florida 33606
United StatesSite Not Available
Rexburg Pediatrics
Rexburg, Idaho 83440
United StatesSite Not Available
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois 60611
United StatesSite Not Available
Norton Children's Research Institute
Louisville, Kentucky 40202
United StatesSite Not Available
MedPharmics - Lafayette
Lafayette, Louisiana 70508
United StatesSite Not Available
LSU Health
Shreveport, Louisiana 71101
United StatesSite Not Available
Willis-Knighton Health System
Shreveport, Louisiana 71103
United StatesSite Not Available
Boston Children's Hospital - Division of Adolescent/Youth Adult Medicine
Boston, Massachusetts 02115
United StatesSite Not Available
Office of Craig A. Spiegel, MD
Bridgeton, Missouri 63044
United StatesSite Not Available
Toledo Hospital
Toledo, Ohio 43606
United StatesSite Not Available
Medical University of South Carolina
Charleston, South Carolina 29425
United StatesSite Not Available
Coastal Pediatric Associates - Mount Pleasant
Summerville, South Carolina 29486
United StatesSite Not Available
Holston Medical Group
Kingsport, Tennessee 37660
United StatesSite Not Available
Le Bonheur Children's Hospital
Memphis, Tennessee 38103
United StatesSite Not Available
Driscoll Children's Hospital
Corpus Christi, Texas 78411
United StatesSite Not Available
Children's Health Specialty Center Dallas Campus
Dallas, Texas 75207
United StatesSite Not Available
Pediatric Research of Charlottesville
Charlottesville, Virginia 22902
United StatesSite Not Available
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