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

RSV Infection Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05568706
• Other study ID #: EDP 938-104
• Status: Recruiting
• Phase: Phase 2
• 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
• 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

Related Conditions & MeSH terms

• Infections
• Respiratory Syncytial Virus Infections
• RSV Infection

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