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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05568706
Other study ID # EDP 938-104
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date November 29, 2022
Est. completion date April 2024

Study information

Verified date October 2022
Source Enanta Pharmaceuticals, Inc
Contact Enanta Pharmaceuticals, Inc
Phone 617 607-0800
Email charris@enanta.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 180
Est. completion date April 2024
Est. primary completion date April 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Drug:
EDP-938
Subjects will take EDP-938 once daily for 5 days
Placebo
Subjects will take matching placebo, once daily for 5 days

Locations

Country Name City State
Argentina CINME S.A. - Centro de Investigaciones Metabólicas - Rx Trials LLC Buenos Aires
Argentina Consultorios Médicos Dr. Doreski Ciudad Autónoma de Buenos Aires Ciudad Autónoma De BuenosAires
Argentina Instituto de Medicina Respiratoria, IMeR Córdoba
Argentina 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 Instituto Médico Río Cuarto Río Cuarto Cordoba
Argentina Instituto Médico de la Fundación Estudios Clínicos Rosario Santa Fe
Argentina Centro de Investigaciones Médicas Tucumán San Miguel De Tucumán San Miguel
Argentina Clinica Mayo de U.M.C.B. S.R.L San Miguel De Tucumán Tucumán
Argentina Instituto Del Buen Aire Santa Fe
Brazil L2 Ip - Instituto de Pesquisas Clinicas Ltda - ME Brasília Distrito Federal
Brazil CPCLIN Centro de Pesquisas Clínicas Ltda Sao Paulo
Bulgaria Multiprofile Hospital for Active Treatment Puls AD - PPDS Blagoevgrad
Bulgaria Medical Center For Life EOOD Burgas
Bulgaria Medical Center Zdrave-1 OOD Kozloduy
Bulgaria Medical Center Hera - Kyustendil EOOD Kyustendil
Bulgaria Diagnostic Consultative Center 1- Lom EOOD Lom Montana
Bulgaria Medical Center Hera EOOD, Montana Montana
Bulgaria Specialized Hospital for Active Treatment of Pulmonary Diseases- Pernik EOOD Pernik
Bulgaria Medical Center Medconsult Pleven OOD Pleven Plevan
Bulgaria Medical Center Prolet EOOD Ruse
Bulgaria Diagnostic Consultative Center-1-Sevlievo EOOD Sevlievo Gabrovo
Bulgaria Medical Center Hipocrena Sevlievo
Bulgaria Medical Center Hera EOOD Sofia
Bulgaria Medical Center Sanador M EOOD Sofia Sofia Grad
Bulgaria University Multiprofile Hospital for Active Treatment Sofiamed OOD Sofia
Bulgaria Specialized Hospital for Active Treatment of Pulmonary Diseases Troyan Lovech
Bulgaria Medical Center Leo Clinic EOOD, Varna Varna
Bulgaria Medical Center Neuromedix EOOD Veliko Tarnovo
Bulgaria Medical Center Tara OOD Veliko Tarnovo
Czechia Ordinace Hradební s.r.o. Ceské Budejovice
Czechia MediTrial s.r.o. Jindrichuv Hradec Jihoceský Kraj
Czechia MUDr. Jakub Strincl, s.r.o. Liberec Liberecký Kraj
Czechia Res Medica s.r.o. Nový Knín
Czechia MEDISON, s.r.o. Preštice
Czechia Praktický lékar Všestary s.r.o Všestary Královéhradecký Kraj
Czechia Progerint s.r.o. Vysoké Mýto Pardubický Kraj
Israel Clalit HMO - Atlit Atlit Haifa
Israel Matan Clinic Clalit Matan HaMerkaz
Malaysia Sultan Ahmad Shah Medical Centre at IIUM Kuantan Pahang
Netherlands Huisartsenpraktijk Broekman Rotterdam Zuid-Holland
Netherlands Office of Dr Mangal Rotterdam Zuid-Holland
Netherlands Office of Dr Rambharose 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
Poland Centrum Medyczne PROFAMILIA Lódz Lodzkie
Poland Specjalistyczny Osrodek Leczniczo-Badawczy Zbigniew Zegota Ostróda
Poland EMC Instytut Medyczny S.A.PL CERTUS Szpital i Ambulatorium Poznan Wielkopolskie
Poland PULMAG Grzegorz Gasior Marzena Kociolek Spolka Cywilna Sosnowiec
Poland NZOZ IGNIS dr med. Alicja Lobinska Swidnik Lubelskie
Poland Alergo-Med Specjalistyczna Przychodnia Lekarska Sp. z.o.o Tarnów Malopolskie
Poland Centrum Badan Klinicznych Piotr Napora Lekarze Spolka Partnerska Wroclaw Dolnoslaskie
Puerto Rico Caribbean Medical Research Center San Juan
Slovakia ALIAN, s.r.o Bardejov
Slovakia Plucna ambulancia Hrebenar, s.r.o. Spišská Nová Ves
South Africa Tiervlei Trial Centre-43 Old Oak Road Cape Town
South Africa Newtown Clinical Research Centre Johannesburg
South Africa Zinakekele Medical Centre Kwamhlanga Mpumalanga
South Africa Be Part Yoluntu Centre Paarl
South Africa Clinical Trial Systems Pretoria
Spain Hospital General Universitario Dr. Balmis Alicante
Spain Hospital HM Nou Delfos Barcelona
Spain Centro de salud Cabra Matrona Antonia Mesa Fernández Cabra Cordoba
Spain Hospital Costa del Sol Marbella Malaga
Spain CHUS - H. Clinico U. de Santiago Santiago De Compostela
Taiwan Kaohsiung Medical University - Chung-Ho Memorial Hospital Kaohsiung City
Taiwan National Taiwan University Hospital Taipei
Taiwan Taipei Municipal Wanfang Hospital Taipei
Taiwan Tri-Service General Hospital Taipei
United States Accelemed Research Institute Austin Texas
United States Inquest Clinical Research Baytown Texas
United States Nebraska Medical Research Institute, Inc Bellevue Nebraska
United States Mercury Street Medical Butte Montana
United States C&A Clinical Trials Corp Cape Coral Florida
United States ClinSearch, LLC - M3 WR Chattanooga Tennessee
United States Acute Care Emergence Columbus Georgia
United States Beautiful Minds Clinical Research Center Cutler Bay Florida
United States Allianz Research Institute Denver Colorado
United States Covenant Pulmonary Criticial Care and Research Ins East Point Georgia
United States Medisphere Medical Research Center LLC Evansville Indiana
United States Valley Institute of Research Fort Worth Texas
United States Ascada Research LLC Fullerton California
United States Velocity Clinical Research - Gulfport - PPDS Gulfport Mississippi
United States HDH Research, Inc. Houston Texas
United States Longwood Research Huntsville Alabama
United States I.H.S Health LLC Kissimmee Florida
United States Velocity Clinical Research - Covington - PPDS Lafayette Louisiana
United States Clinical Research of South Nevada - Clinedge - PPDS Las Vegas Nevada
United States Main Street Physicians Care Little River South Carolina
United States Torrance Clinical Research Institute Lomita California
United States Downtown LA Research Center Inc - ClinEdge - PPDS Los Angeles California
United States Medical Arts Research Center Madison Heights Michigan
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 Dynamic Medical Research, LLC Miami Florida
United States Floridian Research Institute Miami Florida
United States San Marcus Research Clinic Inc Miami Florida
United States Myrak Research Center Inc. Miami Lakes Florida
United States Del Pilar Medical and Urgent Care Mishawaka Indiana
United States Burke Primary Care Morganton North Carolina
United States Raritan Bay Primary Care & Cardiology Associates Old Bridge New Jersey
United States Florida Institute For Clinical Research LLC Orlando Florida
United States Ormond Beach Clinical Research Ormond Beach Florida
United States Capitis Medical And Aesthetics Roseville California
United States CRMD Research LLC San Bernardino California
United States Spartanburg Medical Research Spartanburg South Carolina
United States Santos Research Center Tampa Florida
United States Voyage Medical Tempe Arizona
United States Toledo Institute of Clinical Research Toledo Ohio
United States Safe Haven Clinical Research Vicksburg Mississippi
United States Velocity Clinical Research Westlake California
United States Allianz Research Institute Inc Westminster California
United States Progressive Medicine of the Triad, LLC Winston-Salem North Carolina

Sponsors (1)

Lead Sponsor Collaborator
Enanta Pharmaceuticals, Inc

Countries where clinical trial is conducted

United States,  Argentina,  Brazil,  Bulgaria,  Czechia,  Israel,  Malaysia,  Netherlands,  Poland,  Puerto Rico,  Slovakia,  South Africa,  Spain,  Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Time to resolution of RSV Lower Respiratory Tract Disease (LRTD) symptoms Day 1 through Day 33
Secondary Time to resolution of LRTD symptoms and 2 systemic symptoms Day 1 through Day 33
Secondary Time to resolution of all RSV symptoms Day 1 through Day 33
Secondary Change from Baseline in severity of RSV LRTD symptoms Day 1 through Day 33
Secondary Change from Baseline for impact scale Day 1 through Day 33
Secondary Time to resolution of Upper Respiratory Tract Disease congestion), LRTD, and 2 systemic symptoms Day 1 through Day 33
Secondary Time to no or mild impact of RSV disease on daily activities, emotions, and social relationships Day 1 through Day 33
Secondary Percentage of participants with post-baseline RSV-related complications Day 1 through Day 33
Secondary Time to improvement in RSV disease Day 1 through Day 33
Secondary Change from Baseline for Health-Related Quality of Life Day 1 through Day 33
Secondary Time to return to usual health Day 1 through Day 33
Secondary Time to return to usual activities Day 1 through Day 33
Secondary Percentage of subjects requiring hospitalization for RSV or other causes; Day 1 through Day 33
Secondary Duration of hospitalization for RSV or other causes Day 1 through Day 33
Secondary All-cause mortality Day 1 through Day 33
Secondary RSV RNA viral load change from Baseline Days 3, 5, 9, and 14
Secondary Change in infectious RSV viral load over time Up to Day 14
Secondary Plasma PK Concentrations of EDP-938 Up to Day 5
Secondary Safety as measured by frequency of adverse events (AEs) Up to Day 33
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