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

Primary Purpose

RSV Infection

Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
EDP-938
Placebo
Sponsored by
Enanta Pharmaceuticals, Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for RSV Infection focused on measuring High Risk, Respiratory Syncytial Virus

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Longwood ResearchRecruiting
  • Voyage MedicalRecruiting
  • Ascada Research LLCRecruiting
  • Torrance Clinical Research InstituteRecruiting
  • Downtown LA Research Center Inc - ClinEdge - PPDSRecruiting
  • Capitis Medical And AestheticsRecruiting
  • CRMD Research LLCRecruiting
  • Velocity Clinical ResearchRecruiting
  • Allianz Research Institute IncRecruiting
  • Allianz Research InstituteRecruiting
  • C&A Clinical Trials CorpRecruiting
  • Beautiful Minds Clinical Research CenterRecruiting
  • I.H.S Health LLCRecruiting
  • Myrak Research Center Inc.Recruiting
  • San Marcus Research Clinic IncRecruiting
  • Dynamic Medical Research, LLCRecruiting
  • Floridian Research InstituteRecruiting
  • Florida Institute For Clinical Research LLCRecruiting
  • Ormond Beach Clinical ResearchRecruiting
  • Santos Research CenterRecruiting
  • Acute Care EmergenceRecruiting
  • Covenant Pulmonary Criticial Care and Research InsRecruiting
  • Medisphere Medical Research Center LLCRecruiting
  • Del Pilar Medical and Urgent CareRecruiting
  • Velocity Clinical Research - Covington - PPDSRecruiting
  • Medical Arts Research CenterRecruiting
  • Velocity Clinical Research - Gulfport - PPDSRecruiting
  • Safe Haven Clinical ResearchRecruiting
  • Mercury Street MedicalRecruiting
  • Nebraska Medical Research Institute, IncRecruiting
  • Clinical Research of South Nevada - Clinedge - PPDSRecruiting
  • Raritan Bay Primary Care & Cardiology AssociatesRecruiting
  • Burke Primary CareRecruiting
  • Progressive Medicine of the Triad, LLCRecruiting
  • Toledo Institute of Clinical ResearchRecruiting
  • Main Street Physicians CareRecruiting
  • Spartanburg Medical ResearchRecruiting
  • ClinSearch, LLC - M3 WRRecruiting
  • Accelemed Research InstituteRecruiting
  • Inquest Clinical ResearchRecruiting
  • Valley Institute of ResearchRecruiting
  • HDH Research, Inc.Recruiting
  • Metroplex Pulmonary and Sleep Medicine Center-4833 Medical Center Dr Unit 6BRecruiting
  • SMS Clinical Research, LLCRecruiting
  • Instituto De Enfermedades Respiratorias E Investigacion MedicaRecruiting
  • Instituto Medico PlatenseRecruiting
  • Centro de Investigaciones Medica Mar del PlataRecruiting
  • Clinica Privada IndependenciaRecruiting
  • Consultorios Médicos Dr. DoreskiRecruiting
  • Instituto Médico Río CuartoRecruiting
  • Centro de Investigaciones Médicas TucumánRecruiting
  • Instituto Médico de la Fundación Estudios ClínicosRecruiting
  • Clinica Mayo de U.M.C.B. S.R.LRecruiting
  • CINME S.A. - Centro de Investigaciones Metabólicas - Rx Trials LLCRecruiting
  • Instituto de Medicina Respiratoria, IMeRRecruiting
  • Instituto Del Buen AireRecruiting
  • L2 Ip - Instituto de Pesquisas Clinicas Ltda - MERecruiting
  • CPCLIN Centro de Pesquisas Clínicas LtdaRecruiting
  • Diagnostic Consultative Center-1-Sevlievo EOODRecruiting
  • Specialized Hospital for Active Treatment of Pulmonary DiseasesRecruiting
  • Diagnostic Consultative Center 1- Lom EOODRecruiting
  • Medical Center Medconsult Pleven OODRecruiting
  • Medical Center Sanador M EOODRecruiting
  • Multiprofile Hospital for Active Treatment Puls AD - PPDSRecruiting
  • Medical Center For Life EOODRecruiting
  • Medical Center Zdrave-1 OODRecruiting
  • Medical Center Hera - Kyustendil EOODRecruiting
  • Medical Center Hera EOOD, MontanaRecruiting
  • Specialized Hospital for Active Treatment of Pulmonary Diseases- Pernik EOODRecruiting
  • Medical Center Prolet EOODRecruiting
  • Medical Center HipocrenaRecruiting
  • Medical Center Hera EOODRecruiting
  • University Multiprofile Hospital for Active Treatment Sofiamed OODRecruiting
  • Medical Center Leo Clinic EOOD, VarnaRecruiting
  • Medical Center Tara OODRecruiting
  • Medical Center Neuromedix EOODRecruiting
  • MediTrial s.r.o.Recruiting
  • Praktický lékar Všestary s.r.oRecruiting
  • MUDr. Jakub Strincl, s.r.o.Recruiting
  • Progerint s.r.o.Recruiting
  • Res Medica s.r.o.Recruiting
  • MEDISON, s.r.o.Recruiting
  • Ordinace Hradební s.r.o.Recruiting
  • Clalit HMO - AtlitRecruiting
  • Matan Clinic ClalitRecruiting
  • Sultan Ahmad Shah Medical Centre at IIUMRecruiting
  • Huisartsenpraktijk BroekmanRecruiting
  • Office of Dr MangalRecruiting
  • Office of Dr van SoerlandRecruiting
  • Office of Dr VerkleijRecruiting
  • Qclinical B.V.Recruiting
  • Office of Dr RambharoseRecruiting
  • Centrum Badan Klinicznych Piotr Napora Lekarze Spolka PartnerskaRecruiting
  • Centrum Medyczne PROFAMILIARecruiting
  • NZOZ IGNIS dr med. Alicja LobinskaRecruiting
  • Alergo-Med Specjalistyczna Przychodnia Lekarska Sp. z.o.oRecruiting
  • EMC Instytut Medyczny S.A.PL CERTUS Szpital i AmbulatoriumRecruiting
  • Specjalistyczny Osrodek Leczniczo-Badawczy Zbigniew ZegotaRecruiting
  • PULMAG Grzegorz Gasior Marzena Kociolek Spolka CywilnaRecruiting
  • Caribbean Medical Research CenterRecruiting
  • ALIAN, s.r.oRecruiting
  • Plucna ambulancia Hrebenar, s.r.o.Recruiting
  • Zinakekele Medical CentreRecruiting
  • Tiervlei Trial Centre-43 Old Oak RoadRecruiting
  • Newtown Clinical Research CentreRecruiting
  • Be Part Yoluntu CentreRecruiting
  • Clinical Trial SystemsRecruiting
  • Centro de salud Cabra Matrona Antonia Mesa FernándezRecruiting
  • Hospital Costa del SolRecruiting
  • Hospital General Universitario Dr. BalmisRecruiting
  • Hospital HM Nou DelfosRecruiting
  • CHUS - H. Clinico U. de SantiagoRecruiting
  • Kaohsiung Medical University - Chung-Ho Memorial HospitalRecruiting
  • Tri-Service General HospitalRecruiting
  • Taipei Municipal Wanfang HospitalRecruiting
  • National Taiwan University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

EDP-938

Placebo

Arm Description

EDP-938 800 mg, once daily

Matching placebo, once daily

Outcomes

Primary Outcome Measures

Time to resolution of RSV Lower Respiratory Tract Disease (LRTD) symptoms

Secondary Outcome Measures

Time to resolution of LRTD symptoms and 2 systemic symptoms
Time to resolution of all RSV symptoms
Change from Baseline in severity of RSV LRTD symptoms
Change from Baseline for impact scale
Time to resolution of Upper Respiratory Tract Disease congestion), LRTD, and 2 systemic symptoms
Time to no or mild impact of RSV disease on daily activities, emotions, and social relationships
Percentage of participants with post-baseline RSV-related complications
Time to improvement in RSV disease
Change from Baseline for Health-Related Quality of Life
Time to return to usual health
Time to return to usual activities
Percentage of subjects requiring hospitalization for RSV or other causes;
Duration of hospitalization for RSV or other causes
All-cause mortality
RSV RNA viral load change from Baseline
Change in infectious RSV viral load over time
Plasma PK Concentrations of EDP-938
Safety as measured by frequency of adverse events (AEs)

Full Information

First Posted
October 3, 2022
Last Updated
September 12, 2023
Sponsor
Enanta Pharmaceuticals, Inc
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1. Study Identification

Unique Protocol Identification Number
NCT05568706
Brief Title
A Study of EDP-938 in Non-hospitalized Adults With RSV Who Are at High Risk for Complications.
Acronym
RSVHR
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 29, 2022 (Actual)
Primary Completion Date
April 2024 (Anticipated)
Study Completion Date
April 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Enanta Pharmaceuticals, Inc

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
RSV Infection
Keywords
High Risk, Respiratory Syncytial Virus

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
180 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
EDP-938
Arm Type
Experimental
Arm Description
EDP-938 800 mg, once daily
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Matching placebo, once daily
Intervention Type
Drug
Intervention Name(s)
EDP-938
Intervention Description
Subjects will take EDP-938 once daily for 5 days
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Subjects will take matching placebo, once daily for 5 days
Primary Outcome Measure Information:
Title
Time to resolution of RSV Lower Respiratory Tract Disease (LRTD) symptoms
Time Frame
Day 1 through Day 33
Secondary Outcome Measure Information:
Title
Time to resolution of LRTD symptoms and 2 systemic symptoms
Time Frame
Day 1 through Day 33
Title
Time to resolution of all RSV symptoms
Time Frame
Day 1 through Day 33
Title
Change from Baseline in severity of RSV LRTD symptoms
Time Frame
Day 1 through Day 33
Title
Change from Baseline for impact scale
Time Frame
Day 1 through Day 33
Title
Time to resolution of Upper Respiratory Tract Disease congestion), LRTD, and 2 systemic symptoms
Time Frame
Day 1 through Day 33
Title
Time to no or mild impact of RSV disease on daily activities, emotions, and social relationships
Time Frame
Day 1 through Day 33
Title
Percentage of participants with post-baseline RSV-related complications
Time Frame
Day 1 through Day 33
Title
Time to improvement in RSV disease
Time Frame
Day 1 through Day 33
Title
Change from Baseline for Health-Related Quality of Life
Time Frame
Day 1 through Day 33
Title
Time to return to usual health
Time Frame
Day 1 through Day 33
Title
Time to return to usual activities
Time Frame
Day 1 through Day 33
Title
Percentage of subjects requiring hospitalization for RSV or other causes;
Time Frame
Day 1 through Day 33
Title
Duration of hospitalization for RSV or other causes
Time Frame
Day 1 through Day 33
Title
All-cause mortality
Time Frame
Day 1 through Day 33
Title
RSV RNA viral load change from Baseline
Time Frame
Days 3, 5, 9, and 14
Title
Change in infectious RSV viral load over time
Time Frame
Up to Day 14
Title
Plasma PK Concentrations of EDP-938
Time Frame
Up to Day 5
Title
Safety as measured by frequency of adverse events (AEs)
Time Frame
Up to Day 33

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Enanta Pharmaceuticals, Inc
Phone
617 607-0800
Email
charris@enanta.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Enanta Pharmaceuticals, Inc
Organizational Affiliation
Enanta Pharmaceuticals, Inc
Official's Role
Study Director
Facility Information:
Facility Name
Longwood Research
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
Individual Site Status
Recruiting
Facility Name
Voyage Medical
City
Tempe
State/Province
Arizona
ZIP/Postal Code
85282-2455
Country
United States
Individual Site Status
Recruiting
Facility Name
Ascada Research LLC
City
Fullerton
State/Province
California
ZIP/Postal Code
92835-3424
Country
United States
Individual Site Status
Recruiting
Facility Name
Torrance Clinical Research Institute
City
Lomita
State/Province
California
ZIP/Postal Code
90717
Country
United States
Individual Site Status
Recruiting
Facility Name
Downtown LA Research Center Inc - ClinEdge - PPDS
City
Los Angeles
State/Province
California
ZIP/Postal Code
90017
Country
United States
Individual Site Status
Recruiting
Facility Name
Capitis Medical And Aesthetics
City
Roseville
State/Province
California
ZIP/Postal Code
95678-2474
Country
United States
Individual Site Status
Recruiting
Facility Name
CRMD Research LLC
City
San Bernardino
State/Province
California
ZIP/Postal Code
92408-3406
Country
United States
Individual Site Status
Recruiting
Facility Name
Velocity Clinical Research
City
Westlake
State/Province
California
ZIP/Postal Code
90057
Country
United States
Individual Site Status
Recruiting
Facility Name
Allianz Research Institute Inc
City
Westminster
State/Province
California
ZIP/Postal Code
92683
Country
United States
Individual Site Status
Recruiting
Facility Name
Allianz Research Institute
City
Denver
State/Province
Colorado
ZIP/Postal Code
80219
Country
United States
Individual Site Status
Recruiting
Facility Name
C&A Clinical Trials Corp
City
Cape Coral
State/Province
Florida
ZIP/Postal Code
33990
Country
United States
Individual Site Status
Recruiting
Facility Name
Beautiful Minds Clinical Research Center
City
Cutler Bay
State/Province
Florida
ZIP/Postal Code
33157
Country
United States
Individual Site Status
Recruiting
Facility Name
I.H.S Health LLC
City
Kissimmee
State/Province
Florida
ZIP/Postal Code
34741
Country
United States
Individual Site Status
Recruiting
Facility Name
Myrak Research Center Inc.
City
Miami Lakes
State/Province
Florida
ZIP/Postal Code
33014-2406
Country
United States
Individual Site Status
Recruiting
Facility Name
San Marcus Research Clinic Inc
City
Miami
State/Province
Florida
ZIP/Postal Code
33014
Country
United States
Individual Site Status
Recruiting
Facility Name
Dynamic Medical Research, LLC
City
Miami
State/Province
Florida
ZIP/Postal Code
33144
Country
United States
Individual Site Status
Recruiting
Facility Name
Floridian Research Institute
City
Miami
State/Province
Florida
ZIP/Postal Code
33179-2537
Country
United States
Individual Site Status
Recruiting
Facility Name
Florida Institute For Clinical Research LLC
City
Orlando
State/Province
Florida
ZIP/Postal Code
32825
Country
United States
Individual Site Status
Recruiting
Facility Name
Ormond Beach Clinical Research
City
Ormond Beach
State/Province
Florida
ZIP/Postal Code
32174
Country
United States
Individual Site Status
Recruiting
Facility Name
Santos Research Center
City
Tampa
State/Province
Florida
ZIP/Postal Code
33615
Country
United States
Individual Site Status
Recruiting
Facility Name
Acute Care Emergence
City
Columbus
State/Province
Georgia
ZIP/Postal Code
31909-1723
Country
United States
Individual Site Status
Recruiting
Facility Name
Covenant Pulmonary Criticial Care and Research Ins
City
East Point
State/Province
Georgia
ZIP/Postal Code
30344
Country
United States
Individual Site Status
Recruiting
Facility Name
Medisphere Medical Research Center LLC
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47712
Country
United States
Individual Site Status
Recruiting
Facility Name
Del Pilar Medical and Urgent Care
City
Mishawaka
State/Province
Indiana
ZIP/Postal Code
46545
Country
United States
Individual Site Status
Recruiting
Facility Name
Velocity Clinical Research - Covington - PPDS
City
Lafayette
State/Province
Louisiana
ZIP/Postal Code
70508
Country
United States
Individual Site Status
Recruiting
Facility Name
Medical Arts Research Center
City
Madison Heights
State/Province
Michigan
ZIP/Postal Code
48071
Country
United States
Individual Site Status
Recruiting
Facility Name
Velocity Clinical Research - Gulfport - PPDS
City
Gulfport
State/Province
Mississippi
ZIP/Postal Code
39503
Country
United States
Individual Site Status
Recruiting
Facility Name
Safe Haven Clinical Research
City
Vicksburg
State/Province
Mississippi
ZIP/Postal Code
39183-4408
Country
United States
Individual Site Status
Recruiting
Facility Name
Mercury Street Medical
City
Butte
State/Province
Montana
ZIP/Postal Code
59701
Country
United States
Individual Site Status
Recruiting
Facility Name
Nebraska Medical Research Institute, Inc
City
Bellevue
State/Province
Nebraska
ZIP/Postal Code
68046
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research of South Nevada - Clinedge - PPDS
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89121
Country
United States
Individual Site Status
Recruiting
Facility Name
Raritan Bay Primary Care & Cardiology Associates
City
Old Bridge
State/Province
New Jersey
ZIP/Postal Code
08857
Country
United States
Individual Site Status
Recruiting
Facility Name
Burke Primary Care
City
Morganton
State/Province
North Carolina
ZIP/Postal Code
28655
Country
United States
Individual Site Status
Recruiting
Facility Name
Progressive Medicine of the Triad, LLC
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Individual Site Status
Recruiting
Facility Name
Toledo Institute of Clinical Research
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43617
Country
United States
Individual Site Status
Recruiting
Facility Name
Main Street Physicians Care
City
Little River
State/Province
South Carolina
ZIP/Postal Code
29566
Country
United States
Individual Site Status
Recruiting
Facility Name
Spartanburg Medical Research
City
Spartanburg
State/Province
South Carolina
ZIP/Postal Code
29303
Country
United States
Individual Site Status
Recruiting
Facility Name
ClinSearch, LLC - M3 WR
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37421-1651
Country
United States
Individual Site Status
Recruiting
Facility Name
Accelemed Research Institute
City
Austin
State/Province
Texas
ZIP/Postal Code
78704-7507
Country
United States
Individual Site Status
Recruiting
Facility Name
Inquest Clinical Research
City
Baytown
State/Province
Texas
ZIP/Postal Code
77521
Country
United States
Individual Site Status
Recruiting
Facility Name
Valley Institute of Research
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76164-9041
Country
United States
Individual Site Status
Recruiting
Facility Name
HDH Research, Inc.
City
Houston
State/Province
Texas
ZIP/Postal Code
77022
Country
United States
Individual Site Status
Recruiting
Facility Name
Metroplex Pulmonary and Sleep Medicine Center-4833 Medical Center Dr Unit 6B
City
McKinney
State/Province
Texas
ZIP/Postal Code
75069
Country
United States
Individual Site Status
Recruiting
Facility Name
SMS Clinical Research, LLC
City
Mesquite
State/Province
Texas
ZIP/Postal Code
75149
Country
United States
Individual Site Status
Recruiting
Facility Name
Instituto De Enfermedades Respiratorias E Investigacion Medica
City
Florencio Varela
State/Province
Buenos Aires
ZIP/Postal Code
1888
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Instituto Medico Platense
City
La Plata
State/Province
Buenos Aires
ZIP/Postal Code
1900
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Centro de Investigaciones Medica Mar del Plata
City
Mar Del Plata
State/Province
Buenos Aires
ZIP/Postal Code
B7600FYK
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Clinica Privada Independencia
City
Munro
State/Province
Buenos Aires
ZIP/Postal Code
B1605
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Consultorios Médicos Dr. Doreski
City
Ciudad Autónoma de Buenos Aires
State/Province
Ciudad Autónoma De BuenosAires
ZIP/Postal Code
C1426ABP
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Instituto Médico Río Cuarto
City
Río Cuarto
State/Province
Cordoba
ZIP/Postal Code
5800
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Centro de Investigaciones Médicas Tucumán
City
San Miguel De Tucumán
State/Province
San Miguel
ZIP/Postal Code
T4000AXL
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Instituto Médico de la Fundación Estudios Clínicos
City
Rosario
State/Province
Santa Fe
ZIP/Postal Code
S2013DTC
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Clinica Mayo de U.M.C.B. S.R.L
City
San Miguel De Tucumán
State/Province
Tucumán
ZIP/Postal Code
T4000NWB
Country
Argentina
Individual Site Status
Recruiting
Facility Name
CINME S.A. - Centro de Investigaciones Metabólicas - Rx Trials LLC
City
Buenos Aires
ZIP/Postal Code
C1221ABL
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Instituto de Medicina Respiratoria, IMeR
City
Córdoba
ZIP/Postal Code
X5000DCE
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Instituto Del Buen Aire
City
Santa Fe
ZIP/Postal Code
3000
Country
Argentina
Individual Site Status
Recruiting
Facility Name
L2 Ip - Instituto de Pesquisas Clinicas Ltda - ME
City
Brasília
State/Province
Distrito Federal
ZIP/Postal Code
70200-715
Country
Brazil
Individual Site Status
Recruiting
Facility Name
CPCLIN Centro de Pesquisas Clínicas Ltda
City
Sao Paulo
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Diagnostic Consultative Center-1-Sevlievo EOOD
City
Sevlievo
State/Province
Gabrovo
ZIP/Postal Code
5400
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Specialized Hospital for Active Treatment of Pulmonary Diseases
City
Troyan
State/Province
Lovech
ZIP/Postal Code
5600
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Diagnostic Consultative Center 1- Lom EOOD
City
Lom
State/Province
Montana
ZIP/Postal Code
3600
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Medical Center Medconsult Pleven OOD
City
Pleven
State/Province
Plevan
ZIP/Postal Code
5800
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Medical Center Sanador M EOOD
City
Sofia
State/Province
Sofia Grad
ZIP/Postal Code
1431
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Multiprofile Hospital for Active Treatment Puls AD - PPDS
City
Blagoevgrad
ZIP/Postal Code
2700
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Medical Center For Life EOOD
City
Burgas
ZIP/Postal Code
8000
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Medical Center Zdrave-1 OOD
City
Kozloduy
ZIP/Postal Code
3320
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Medical Center Hera - Kyustendil EOOD
City
Kyustendil
ZIP/Postal Code
2500
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Medical Center Hera EOOD, Montana
City
Montana
ZIP/Postal Code
3400
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Specialized Hospital for Active Treatment of Pulmonary Diseases- Pernik EOOD
City
Pernik
ZIP/Postal Code
2300
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Medical Center Prolet EOOD
City
Ruse
ZIP/Postal Code
7002
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Medical Center Hipocrena
City
Sevlievo
ZIP/Postal Code
5400
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Medical Center Hera EOOD
City
Sofia
ZIP/Postal Code
1202
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
University Multiprofile Hospital for Active Treatment Sofiamed OOD
City
Sofia
ZIP/Postal Code
1750
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Medical Center Leo Clinic EOOD, Varna
City
Varna
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Medical Center Tara OOD
City
Veliko Tarnovo
ZIP/Postal Code
5000
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Medical Center Neuromedix EOOD
City
Veliko Tarnovo
ZIP/Postal Code
5006
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
MediTrial s.r.o.
City
Jindřichův Hradec
State/Province
Jihoceský Kraj
ZIP/Postal Code
377 01
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Praktický lékar Všestary s.r.o
City
Všestary
State/Province
Královéhradecký Kraj
ZIP/Postal Code
503 12
Country
Czechia
Individual Site Status
Recruiting
Facility Name
MUDr. Jakub Strincl, s.r.o.
City
Liberec
State/Province
Liberecký Kraj
ZIP/Postal Code
460 14
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Progerint s.r.o.
City
Vysoké Mýto
State/Province
Pardubický Kraj
ZIP/Postal Code
566 01
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Res Medica s.r.o.
City
Nový Knín
ZIP/Postal Code
262 03
Country
Czechia
Individual Site Status
Recruiting
Facility Name
MEDISON, s.r.o.
City
Přeštice
ZIP/Postal Code
334 01
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Ordinace Hradební s.r.o.
City
České Budějovice
ZIP/Postal Code
370 01
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Clalit HMO - Atlit
City
Atlit
State/Province
Haifa
ZIP/Postal Code
30300
Country
Israel
Individual Site Status
Recruiting
Facility Name
Matan Clinic Clalit
City
Matan
State/Province
HaMerkaz
ZIP/Postal Code
45858
Country
Israel
Individual Site Status
Recruiting
Facility Name
Sultan Ahmad Shah Medical Centre at IIUM
City
Kuantan
State/Province
Pahang
ZIP/Postal Code
25200
Country
Malaysia
Individual Site Status
Recruiting
Facility Name
Huisartsenpraktijk Broekman
City
Rotterdam
State/Province
Zuid-Holland
ZIP/Postal Code
3051 GV
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Office of Dr Mangal
City
Rotterdam
State/Province
Zuid-Holland
ZIP/Postal Code
3051 GV
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Office of Dr van Soerland
City
Rotterdam
State/Province
Zuid-Holland
ZIP/Postal Code
3051 GV
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Office of Dr Verkleij
City
Rotterdam
State/Province
Zuid-Holland
ZIP/Postal Code
3051 GV
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Qclinical B.V.
City
Rotterdam
State/Province
Zuid-Holland
ZIP/Postal Code
3051 GV
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Office of Dr Rambharose
City
Rotterdam
State/Province
Zuid-Holland
ZIP/Postal Code
3051-GV
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Centrum Badan Klinicznych Piotr Napora Lekarze Spolka Partnerska
City
Wrocław
State/Province
Dolnoslaskie
ZIP/Postal Code
51-162
Country
Poland
Individual Site Status
Recruiting
Facility Name
Centrum Medyczne PROFAMILIA
City
Łódź
State/Province
Lodzkie
ZIP/Postal Code
91-463
Country
Poland
Individual Site Status
Recruiting
Facility Name
NZOZ IGNIS dr med. Alicja Lobinska
City
Świdnik
State/Province
Lubelskie
ZIP/Postal Code
21-040
Country
Poland
Individual Site Status
Recruiting
Facility Name
Alergo-Med Specjalistyczna Przychodnia Lekarska Sp. z.o.o
City
Tarnów
State/Province
Malopolskie
ZIP/Postal Code
33-100
Country
Poland
Individual Site Status
Recruiting
Facility Name
EMC Instytut Medyczny S.A.PL CERTUS Szpital i Ambulatorium
City
Poznań
State/Province
Wielkopolskie
ZIP/Postal Code
60-309
Country
Poland
Individual Site Status
Recruiting
Facility Name
Specjalistyczny Osrodek Leczniczo-Badawczy Zbigniew Zegota
City
Ostróda
ZIP/Postal Code
14-100
Country
Poland
Individual Site Status
Recruiting
Facility Name
PULMAG Grzegorz Gasior Marzena Kociolek Spolka Cywilna
City
Sosnowiec
ZIP/Postal Code
41-208
Country
Poland
Individual Site Status
Recruiting
Facility Name
Caribbean Medical Research Center
City
San Juan
ZIP/Postal Code
00918
Country
Puerto Rico
Individual Site Status
Recruiting
Facility Name
ALIAN, s.r.o
City
Bardejov
ZIP/Postal Code
085 01
Country
Slovakia
Individual Site Status
Recruiting
Facility Name
Plucna ambulancia Hrebenar, s.r.o.
City
Spišská Nová Ves
ZIP/Postal Code
052 01
Country
Slovakia
Individual Site Status
Recruiting
Facility Name
Zinakekele Medical Centre
City
Kwamhlanga
State/Province
Mpumalanga
ZIP/Postal Code
1022
Country
South Africa
Individual Site Status
Recruiting
Facility Name
Tiervlei Trial Centre-43 Old Oak Road
City
Cape Town
ZIP/Postal Code
7530
Country
South Africa
Individual Site Status
Recruiting
Facility Name
Newtown Clinical Research Centre
City
Johannesburg
ZIP/Postal Code
2001
Country
South Africa
Individual Site Status
Recruiting
Facility Name
Be Part Yoluntu Centre
City
Paarl
ZIP/Postal Code
7646
Country
South Africa
Individual Site Status
Recruiting
Facility Name
Clinical Trial Systems
City
Pretoria
Country
South Africa
Individual Site Status
Recruiting
Facility Name
Centro de salud Cabra Matrona Antonia Mesa Fernández
City
Cabra
State/Province
Cordoba
ZIP/Postal Code
14940
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Costa del Sol
City
Marbella
State/Province
Malaga
ZIP/Postal Code
29600
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital General Universitario Dr. Balmis
City
Alicante
ZIP/Postal Code
03010
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital HM Nou Delfos
City
Barcelona
ZIP/Postal Code
08023
Country
Spain
Individual Site Status
Recruiting
Facility Name
CHUS - H. Clinico U. de Santiago
City
Santiago De Compostela
ZIP/Postal Code
15706
Country
Spain
Individual Site Status
Recruiting
Facility Name
Kaohsiung Medical University - Chung-Ho Memorial Hospital
City
Kaohsiung City
ZIP/Postal Code
807
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Tri-Service General Hospital
City
Taipei
ZIP/Postal Code
11490
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Taipei Municipal Wanfang Hospital
City
Taipei
ZIP/Postal Code
116
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
National Taiwan University Hospital
City
Taipei
Country
Taiwan
Individual Site Status
Recruiting

12. IPD Sharing Statement

Learn more about this trial

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

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