Clinical trial NCT05568706: A Study of EDP-938 in Non-hospitalized Adults With RSV Who Are at High Risk for Complications.
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
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: RSV Infection
Keywords: High Risk, Respiratory Syncytial Virus
Lead sponsor: Enanta Pharmaceuticals, Inc
Sponsor class: INDUSTRY
First posted: 2022-10-06
Enrollment: 186
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Time to resolution of RSV Lower Respiratory Tract Disease (LRTD) symptoms
timeFrame: Day 1 through Day 33
Secondary outcomes:
measure: Time to resolution of LRTD symptoms and 2 systemic symptoms
timeFrame: Day 1 through Day 33
measure: Time to resolution of all RSV symptoms
timeFrame: Day 1 through Day 33
measure: Change from Baseline in severity of RSV LRTD symptoms
timeFrame: Day 1 through Day 33
measure: Change from Baseline for impact scale
timeFrame: Day 1 through Day 33
measure: Time to resolution of Upper Respiratory Tract Disease congestion), LRTD, and 2 systemic symptoms
timeFrame: Day 1 through Day 33
measure: Time to no or mild impact of RSV disease on daily activities, emotions, and social relationships
timeFrame: Day 1 through Day 33
measure: Percentage of participants with post-baseline RSV-related complications
timeFrame: Day 1 through Day 33
measure: Time to improvement in RSV disease
timeFrame: Day 1 through Day 33
measure: Change from Baseline for Health-Related Quality of Life
timeFrame: Day 1 through Day 33
measure: Time to return to usual health
timeFrame: Day 1 through Day 33
measure: Time to return to usual activities
timeFrame: Day 1 through Day 33
measure: Percentage of subjects requiring hospitalization for RSV or other causes;
timeFrame: Day 1 through Day 33
measure: Duration of hospitalization for RSV or other causes
timeFrame: Day 1 through Day 33
measure: All-cause mortality
timeFrame: Day 1 through Day 33
measure: RSV RNA viral load change from Baseline
timeFrame: Days 3, 5, 9, and 14
measure: Change in infectious RSV viral load over time
timeFrame: Up to Day 14
measure: Plasma PK Concentrations of EDP-938
timeFrame: Up to Day 5
measure: Safety as measured by frequency of adverse events (AEs)
timeFrame: Up to Day 33
Other outcomes:
Locations:
city: Tempe
country: United States
facility: Voyage Medical
state: Arizona
city: Fresno
country: United States
facility: UCSF Fresno
state: California
city: Lomita
country: United States
facility: Torrance Clinical Research Institute
state: California
city: Los Angeles
country: United States
facility: Downtown LA Research Center Inc - ClinEdge - PPDS
state: California
city: Westminster
country: United States
facility: Allianz Research Institute Inc
state: California
city: Aurora
country: United States
facility: Allianz Research Institute - Colorado
state: Colorado
city: Bay Pines
country: United States
facility: Bay Pines VA Healthcare System
state: Florida
city: Cape Coral
country: United States
facility: C&A Clinical Trials Corp
state: Florida
city: Cutler Bay
country: United States
facility: Beautiful Minds Clinical Research Center
state: Florida
city: Hialeah
country: United States
facility: Dinamo Research & Diagnostic center, LLC
state: Florida
city: Kissimmee
country: United States
facility: I.H.S Health LLC
state: Florida
city: Miami
country: United States
facility: Dynamic Medical Research, LLC
state: Florida
city: Miami
country: United States
facility: Floridian Research Institute
state: Florida
city: Orlando
country: United States
facility: Orlando VA Healthcare System
state: Florida
city: Ormond Beach
country: United States
facility: Ormond Beach Clinical Research
state: Florida
city: Port Saint Lucie
country: United States
facility: CDC Research Institute, LLC
state: Florida
city: Tampa
country: United States
facility: Research Bay, Inc.
state: Florida
city: Tampa
country: United States
facility: Santos Research Center
state: Florida
city: East Point
country: United States
facility: Covenant Pulmonary Criticial Care and Research Ins
state: Georgia
city: Idaho Falls
country: United States
facility: Snake River Research
state: Idaho
city: Louisville
country: United States
facility: University of Louisville
state: Kentucky
city: Butte
country: United States
facility: Mercury Street Medical
state: Montana
city: Syracuse
country: United States
facility: Global Health Institute
state: New York
city: Winston-Salem
country: United States
facility: Progressive Medicine of the Triad, LLC
state: North Carolina
city: Toledo
country: United States
facility: Toledo Institute of Clinical Research
state: Ohio
city: Austin
country: United States
facility: IMA Clinical Research - Austin - PPDS
state: Texas
city: Fort Worth
country: United States
facility: Valley Institute of Research
state: Texas
city: Houston
country: United States
facility: HDH Research, Inc.
state: Texas
city: McKinney
country: United States
facility: Metroplex Pulmonary and Sleep Medicine Center-4833 Medical Center Dr Unit 6B
state: Texas
city: Mesquite
country: United States
facility: SMS Clinical Research, LLC
state: Texas
city: Redmond
country: United States
facility: Eastside Research Associates
state: Washington
city: La Plata
country: Argentina
facility: Instituto Medico Platense
state: Buenos Aires
city: Mar Del Plata
country: Argentina
facility: Centro de Investigaciones Medica Mar del Plata
state: Buenos Aires
city: Munro
country: Argentina
facility: Clinica Privada Independencia
state: Buenos Aires
city: Ciudad Autónoma de Buenos Aires
country: Argentina
facility: Consultorios Médicos Dr. Doreski
state: Ciudad Autónoma de BuenosAires
city: Río Cuarto
country: Argentina
facility: Instituto Médico Río Cuarto
state: Cordoba
city: San Miguel De Tucumán
country: Argentina
facility: Clinica Mayo de U.M.C.B. S.R.L
state: Tucumán
city: Santa Fe
country: Argentina
facility: Instituto Del Buen Aire
city: Sevlievo
country: Bulgaria
facility: Diagnostic Consultative Center-1-Sevlievo EOOD
state: Gabrovo
city: Troyan
country: Bulgaria
facility: Specialized Hospital for Active Treatment of Pulmonary Diseases
state: Lovech
city: Lom
country: Bulgaria
facility: Diagnostic Consultative Center 1- Lom EOOD
state: Montana
city: Sofia
country: Bulgaria
facility: Medical Center Sanador M EOOD
state: Sofia Grad
city: Blagoevgrad
country: Bulgaria
facility: Multiprofile Hospital for Active Treatment Puls AD - PPDS
city: Burgas
country: Bulgaria
facility: Medical Center For Life EOOD
city: Haskovo
country: Bulgaria
facility: Specialized Hospital for Active Treatment of Pneumophthisiatric Diseases - Haskovo EOOD
city: Kozloduy
country: Bulgaria
facility: Medical Center Zdrave-1 OOD
city: Kyustendil
country: Bulgaria
facility: Medical Center Hera - Kyustendil EOOD
city: Montana
country: Bulgaria
facility: Medical Center Hera EOOD, Montana
city: Pernik
country: Bulgaria
facility: Specialized Hospital for Active Treatment of Pulmonary Diseases- Pernik EOOD
city: Ruse
country: Bulgaria
facility: Medical Center Prolet EOOD
city: Sevlievo
country: Bulgaria
facility: Medical Center Hipocrena
city: Sofia
country: Bulgaria
facility: Medical Center Hera EOOD
city: Sofia
country: Bulgaria
facility: University Multiprofile Hospital for Active Treatment Sofiamed OOD
city: Varna
country: Bulgaria
facility: Medical Centre Pratia Clinic EOOD Varna
city: Veliko Tarnovo
country: Bulgaria
facility: Medical Center Tara OOD
city: Veliko Tarnovo
country: Bulgaria
facility: Medical Center Neuromedix EOOD
city: Medellín
country: Colombia
facility: Servicios de Salud IPS Suramericana S.A.S. - IPS Sura Industriales Medellin
state: Antioquia
city: Barranquilla
country: Colombia
facility: Clinica de la Costa Ltda - PPDS
state: Atlántico
city: Chia
country: Colombia
facility: Clínica Universidad De la Sabana
state: Cundinamarca
city: Pereira
country: Colombia
facility: Fundacion Centro de Investigaciones Clinicas IPS Cardiomet Pereira
state: Risaralda
city: Barranquilla
country: Colombia
facility: Oinsamed S.A.S - Clinica Misericordia
city: Medellín
country: Colombia
facility: Fundacion Centro de Investigacion Clinica CIC
city: Liberec
country: Czechia
facility: MUDr. Jakub Strincl, s.r.o.
state: Liberecký kraj
city: Nový Knín
country: Czechia
facility: Res Medica s.r.o.
city: Miri
country: Malaysia
facility: Hospital Miri
state: Sarawak
city: Ciudad de México
country: Mexico
facility: Centro de Atención e Investigación Médica S.A. - México - CAIMED - PPDS
state: Distrito Federal
city: Guadalajara
country: Mexico
facility: Instituto Jalisciense de Investigacion Clinica SA de CV
state: Jalisco
city: Guadalajara
country: Mexico
facility: CICUM San Miguel
state: Jalisco
city: Guadalajara
country: Mexico
facility: Centro de Investigación Clinica Médica y Farmacoló
state: Jalisco
city: Guadalajara
country: Mexico
facility: Hospital Civil Fray Antonio Alcalde
state: Jalisco
city: Monterrey
country: Mexico
facility: Accelerium, S. de R.L. de C.V. - PPDS
state: Nuevo León
city: Monterrey
country: Mexico
facility: Camacho Ortiz, Adrian
state: Nuevo León
city: Oaxaca de Juarez
country: Mexico
facility: Oaxaca Site Management Organization - Clinic - OSMO - PPDS
city: Veracruz
country: Mexico
facility: Centro de Alta Especialidad Dr. Rafael Lucio
city: Veracruz
country: Mexico
facility: FAICIC
city: Łódź
country: Poland
facility: Centrum Medyczne PROFAMILIA
state: Lodzkie
city: Spišská Nová Ves
country: Slovakia
facility: Plucna ambulancia Hrebenar, s.r.o.
city: Johannesburg
country: South Africa
facility: Newtown Clinical Research Centre
city: Paarl
country: South Africa
facility: Be Part Yoluntu Centre
city: Cabra
country: Spain
facility: Centro de salud Cabra Matrona Antonia Mesa Fernández
state: Cordoba
city: Alicante
country: Spain
facility: Hospital General Universitario Dr. Balmis
city: Santiago De Compostela
country: Spain
facility: CHUS - H. Clinico U. de Santiago
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital
city: Taipei
country: Taiwan
facility: Tri-Service General Hospital
Study officials:
affiliation: Enanta Pharmaceuticals, Inc
name: Enanta Pharmaceuticals, Inc
role: STUDY_DIRECTOR
References: