Clinical trial NCT04816721: A Study to Evaluate EDP 938 Regimens in Children With RSV
Official title: A PHASE 2, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, 2-PART STUDY TO EVALUATE EDP-938 REGIMENS IN SUBJECTS AGED 28 DAYS TO 36 MONTHS INFECTED WITH RESPIRATORY SYNCYTIAL VIRUS (RSV)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Respiratory Syncytial Virus (RSV)
Keywords: Respiratory Syncytial Virus, RSV, Pediatric study
Lead sponsor: Enanta Pharmaceuticals, Inc
Sponsor class: INDUSTRY
First posted: 2021-03-25
Enrollment: 96
Sex: ALL
Minimum age (years): 28
Maximum age (years): 36
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A 2-part study to evaluate the safety, pharmacokinetics and efficacy of EDP-938 in children with RSV infection.

Detailed description: This is a randomized, double-blind, dose ranging, placebo-controlled study in respiratory syncytial virus (RSV) among hospitalized and non-hospitalized children aged from 28 days to 36 months, assessing the safety, tolerability, pharmacokinetics, clinical outcome and antiviral activity of a 5 day treatment with EDP-938.

Eligibility criteria: Inclusion Criteria:

* Male or female who is either ≥6 months to ≤36 months (for Age Group 1) or ≥28 days to \<6 months (for Age Group 2), defined at the time of randomization. Subjects in Age 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 1 and ≤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 to comply with protocol requirements, instructions, and protocol-stated restrictions, and the subject is likely to complete the study as planned

Exclusion Criteria:

* Use of or anticipated need for invasive mechanical ventilation, cardiopulmonary bypass, hemodialysis, or extracorporeal membrane oxygenation; or subjects who are not expected to survive the current illness
* Underlying immune deficiency, (e.g., from confirmed human immunodeficiency virus infection or use of an immunosuppressive medication except immunoglobulin A deficiency)
* Receipt of (within 12 months before Screening) or on a waiting list for a bone marrow, stem cell, or solid organ transplant, or who received radiation or chemotherapy (within 12 months before screening)
* Receiving chronic oxygen therapy at home before admission
* Subjects whose mother received an investigational RSV vaccination while pregnant with the subject if they were born at term (≥37 weeks of gestation) and are less than 12 months of age
* In Part 2, subjects dosed with an investigational or approved medication that is intended to prevent or treat RSV infection within the following times before the first dose of study drug: ribavirin 35 days; palivizumab 100 days; nirsevimab 350 days; other RSV-specific monoclonal antibody 5 half-lives of the specific antibody; RSV vaccines 12 months.

Primary outcomes:
measure: Daily change from baseline in RSV shedding
timeFrame: Up to 14 Days
measure: AUC of EDP-938 (Part 1)
timeFrame: Up to 5 days
measure: Predose concentration of EDP-938 (Part 1)
timeFrame: Up to 5 days
measure: Safety and tolerability of EDP-938 compared to placebo measured by adverse events (Part 1)
timeFrame: Up to 29 Days
Secondary outcomes:
measure: AUC for RSV RNA viral load (Part 1 and Part 2)
timeFrame: Up to 14 Days
measure: Daily change in RSV shedding (Part 1)
timeFrame: Up to 14 Days
measure: Proportion of subjects with undetectable level of RSV RNA viral load (Part 1 and Part 2)
timeFrame: Up to 14 Days
measure: Time to RSV RNA viral load being undetectable (Part 1 and Part 2)
timeFrame: Up to 14 Days
measure: AUC of EDP-938 (Part 2)
timeFrame: Up to 5 Days
measure: Predose concentration of EDP-938 (Part 2)
timeFrame: Up to 5 Days
measure: Safety and tolerability of EDP-938 compared to placebo measured by adverse events (Part 2)
timeFrame: Up to 29 Days
measure: Time to discharge for hospitalized subjects (Part 2)
timeFrame: Up to 29 Days
measure: Time to use of oxygen for hospitalized subjects who are not receiving oxygen at the time they receive the first dose of study drug (Part 2)
timeFrame: Up to 29 Days
measure: Proportion of hospitalized subjects requiring oxygen supplementation or have an increased oxygen requirement
timeFrame: Up to 29 Days
Other outcomes:
Locations:
city: Long Beach
country: United States
facility: Memorial Care Miller Children's and Women's Hospital
state: California
city: Los Angeles
country: United States
facility: University of California Los Angeles (UCLA)
state: California
city: Sacramento
country: United States
facility: UC Davis
state: California
city: Orlando
country: United States
facility: Nemours Children's Hospital
state: Florida
city: Tampa
country: United States
facility: South Tampa Center for Advanced Healthcare
state: Florida
city: Rexburg
country: United States
facility: Rexburg Pediatrics
state: Idaho
city: Chicago
country: United States
facility: Ann & Robert H. Lurie Children's Hospital of Chicago
state: Illinois
city: Louisville
country: United States
facility: Norton Children's Research Institute
state: Kentucky
city: Lafayette
country: United States
facility: MedPharmics - Lafayette
state: Louisiana
city: Shreveport
country: United States
facility: LSU Health
state: Louisiana
city: Shreveport
country: United States
facility: Willis-Knighton Health System
state: Louisiana
city: Boston
country: United States
facility: Boston Children's Hospital - Division of Adolescent/Youth Adult Medicine
state: Massachusetts
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Memphis
country: United States
facility: Le Bonheur Children's Hospital
state: Tennessee
city: Corpus Christi
country: United States
facility: Driscoll Children's Hospital
state: Texas
city: Dallas
country: United States
facility: Children's Health Specialty Center Dallas Campus
state: Texas
city: Mar Del Plata
country: Argentina
facility: Clinica del Niño y la Familia
state: Buenos Aires
city: Bahía Blanca
country: Argentina
facility: Hospital Interzonal Dr Jose Penna
city: Buenos Aires
country: Argentina
facility: Clínica Privada del Sol
city: Río Cuarto
country: Argentina
facility: Instituto Medico Rio Cuarto
city: Villa Regina
country: Argentina
facility: Clinica Central S.A
city: Randwick
country: Australia
facility: Sydney Children's Hospital - Randwick
state: New South Wales
city: Westmead
country: Australia
facility: The Children's Hospital at Westmead
state: New South Wales
city: Southport
country: Australia
facility: Gold Coast University Hospital
city: Passo Fundo
country: Brazil
facility: Instituto Méderi de Pesquisa e Saúde
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: Hospital de Clínicas de Porto Alegre
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: Irmandade da Santa Casa de Misericórdia Hospital - Porto Alegre
state: Rio Grande Do Sul
city: Curitiba
country: Brazil
facility: Universidade Federal do Paraná - Hospital de Clínicas
city: Ribeirão Preto
country: Brazil
facility: Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto
city: Marburg
country: Germany
facility: Universitätsklinikum Gießen und Marburg - Gießen
state: Bundesland
city: Erlangen
country: Germany
facility: Universitätsklinikum Erlangen
city: Sankt Augustin
country: Germany
facility: Asklepios Klinik Sankt Augustin
city: Be'er Sheva
country: Israel
facility: Soroka University Medical Center
city: Haifa
country: Israel
facility: Rambam Health Care
city: Haifa
country: Israel
facility: Carmel Medical Center
city: Jerusalem
country: Israel
facility: Hadassah University Hospital Mount Scopu
city: Petach Tikva
country: Israel
facility: Schneider Children's Medical Center Of Israel
city: Seoul
country: Korea, Republic of
facility: Nowon Eulji Medical Center, Eulji University
city: Seoul
country: Korea, Republic of
facility: Kyung Hee University Hospital
city: Seoul
country: Korea, Republic of
facility: Inje University Sanggye Paik Hospital
city: Guadalajara
country: Mexico
facility: Panamerican Clinical Research Mexico - Guadalajara
state: Prados
city: Mexico City
country: Mexico
facility: Instituto Nacional de Pediatría
city: Mexico City
country: Mexico
facility: Hospital Infantil De Mexico Federico Gomez
city: Mexico City
country: Mexico
facility: Karla Adriana Espinosa Bautista
city: Monterrey
country: Mexico
facility: IESCI Clinical Research
city: Querétaro
country: Mexico
facility: PanAmerican Clinical Research
city: Querétaro
country: Mexico
facility: SMIQ S de R.L de C.V
city: Newtown
country: New Zealand
facility: Wellington Regional Hospital
state: Wellington
city: Bydgoszcz
country: Poland
facility: IN-VIVO Bydgoszcz
city: Łódź
country: Poland
facility: Wojewódzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Łodzi
city: Braşov
country: Romania
facility: Spital Clinic de Urgenta Pentru Copii Brasov
state: Brașov
city: Târgu-Mureş
country: Romania
facility: Spitalul Clinic Judetean De Urgenta Târgu Mureș
state: Târgu Mureș
city: Bucharest
country: Romania
facility: Institutul National pentru Sanatatea Mamei si Copilului "Alessandrescu-Rusescu"
city: Westville
country: South Africa
facility: Life Westville Hospital
state: Durban
city: Johannesburg
country: South Africa
facility: Rahima Moosa Mother and Child Hospital
city: Soweto
country: South Africa
facility: Wits Clinical Research
city: Barcelona
country: Spain
facility: Hospital Germans Trias i Pujol
city: Lleida
country: Spain
facility: Hospital Universitario Arnau de Vilanova
city: Madrid
country: Spain
facility: Hospital Clínico San Carlos
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Madrid
country: Spain
facility: Hospital Universitario Fundación Jiménez Díaz
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Madrid
country: Spain
facility: Hospital Universitario Puerta de Hierro - Majadahonda
city: Madrid
country: Spain
facility: Hospital Universitario Quirónsalud Madrid
city: Madrid
country: Spain
facility: Hospital Universitario Severo Ochoa
city: Madrid
country: Spain
facility: Unidad de Ensayos Clínicos Pediátricos
city: Málaga
country: Spain
facility: Hospital Regional Universitario de Málaga
city: Santiago De Compostela
country: Spain
facility: Hospital Clínico Universitario de Santiago
city: Tarragona
country: Spain
facility: Hospital Universitario Joan XXIII de Tarragona
city: Taipei city
country: Taiwan
facility: National Taiwan University Hospital
state: Taipei
city: Taoyuan City
country: Taiwan
facility: Linkou Chang Gung Memorial Hospital, Chang Gung Medical Foundation
state: Taoyuan
city: Hsinchu
country: Taiwan
facility: Hsinchu Mackay Memorial Hospital
city: Kaohsiung
country: Taiwan
facility: Chang Gung Memorial Hospital - Kaohsiung Branch
city: Taichung
country: Taiwan
facility: Chung Shan Medical University Hospital
city: Taipei
country: Taiwan
facility: Taipei Mackay Memorial Hospital
city: Nottingham
country: United Kingdom
facility: Nottingham University Hospitals NHS Trust
state: Nottinghamshire
city: London
country: United Kingdom
facility: St. George's University Hospitals NHS Foundation Trust
city: Sheffield
country: United Kingdom
facility: Sheffield Children's NHS Foundation Trust
Study officials:
affiliation: Enanta Pharmaceuticals, Inc
name: Enanta Pharmaceuticals, Inc
role: STUDY_DIRECTOR
References: