Clinical trial NCT04633187: Effects of EDP-938 in Hematopoietic Cell Transplant Recipients Infected With Respiratory Syncytial Virus of the Upper Respiratory Tract
Official title: A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Effects of EDP-938 in Hematopoietic Cell Transplant Recipients With Acute Respiratory Syncytial Virus Infection of the Upper Respiratory Tract
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Respiratory Syncytial Virus Infections
Lead sponsor: Enanta Pharmaceuticals, Inc
Sponsor class: INDUSTRY
First posted: 2020-11-18
Enrollment: 9
Sex: ALL
Minimum age (years): 16
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This was a Phase 2b, randomized, double-blind, placebo-controlled, multicenter study evaluating the efficacy and safety of EDP-938 in HCT recipients with acute RSV infection and symptoms of URTI.


Eligibility criteria: Inclusion Criteria:

* Received an autologous HCT (within 6 months of signing ICF) or an allogeneic HCT (any time) using any conditioning regimen
* Absolute lymphocyte count (ALC) \<500 cells/ µL in allogeneic HCT recipients. Absolute lymphocyte count (ALC) \<300 cells/ µL in autologous HCT recipients.
* Laboratory confirmed RSV diagnosis from a respiratory sample obtained within 3 days before signing the ICF.
* New onset of at least one of the following respiratory symptoms within 3 days before signing the ICF: nasopharyngeal discharge, nasopharyngeal congestion, sneezing, sinus congestion, sore throat, hoarseness, earache, cough, shortness of breath, respiratory wheeze, or worsening of one of these symptoms if present chronically (associated with a previously existing diagnosis \[eg, chronic rhinorrhea, chronic lung disease\]) in the 3 days before signing the ICF or at Screening.
* No evidence of new abnormalities consistent with LRTI on a chest imaging (chest x-ray and/or computed tomography) performed in the 2 days before signing the ICF or at the Screening visit if there is no chest X-ray and/or computed tomography available in the 2 days before signing the ICF.
* Oxygen saturation \>95% on room air.
* 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:

* Admitted to the hospital primarily for a lower respiratory tract disease of any cause as determined by the Investigator.
* Known to be concurrently infected with other respiratory viruses (eg, severe acute respiratory syndrome coronavirus 2 \[SARS-CoV-2\] or other coronavirus, influenza, parainfluenza, human rhinovirus, adenovirus, human metapneumovirus) within 7 days before signing the ICF, as determined by local testing.
* Clinically significant viremia, bacteremia, or fungemia, or bacterial or fungal pneumonia within 2 weeks before signing the ICF that has not been adequately treated, as determined by the Investigator.
* Known positive human immunodeficiency virus (HIV).
* Any clinical manifestation resulting in QT prolongation.

Primary outcomes:
measure: Percentage of Subjects Who Develop Lower Respiratory Tract (LRTC) Complication
timeFrame: Day 1 through Day 28
Secondary outcomes:
measure: Change From Baseline in RSV RNA Viral Load
timeFrame: Day 1 through Day 49
measure: Proportion of Subjects Progressing to Respiratory Failure (of Any Cause) Requiring Mechanical Ventilation (Invasive or Noninvasive) or All-cause Mortality
timeFrame: Day 1 through Day 49
measure: Safety as Measured the Number of Participants With at Least One Treatment-emergent Adverse Event
timeFrame: Day 1 through Day 49
measure: Plasma PK Concentrations of EDP-938 800mg
timeFrame: Day 1 Predose and Postdose, Day 4 Predose, Day 7 Predose and Postdose, Day 11 Predose, Day 16 Predose, Day 21 Predose and Postdose
Other outcomes:
Locations:
city: Augusta
country: United States
facility: Augusta University Medical Center
state: Georgia
city: Buenos Aires
country: Argentina
facility: Fundación Favaloro
state: Ciudad Autónoma De BuenosAires
city: La Plata
country: Argentina
facility: Instituto Fides
state: Ciudad Autónoma De BuenosAires
city: Córdoba
country: Argentina
facility: Sanatorio Allende S.A.
state: Cordoba
city: Buenos Aires
country: Argentina
facility: Hospital Britanico de Buenos Aires
city: Edegem
country: Belgium
facility: UZ Antwerpen
state: Antwerpen
city: Anderlecht
country: Belgium
facility: Institute Jules Bordet
state: Brussels
city: La Louvière
country: Belgium
facility: Hôpital de Jolimont
city: Brasília
country: Brazil
facility: Chronos Pesquisa Clínica
state: Distrito Federal
city: Porto Alegre
country: Brazil
facility: Hospital de Clinicas de Porto Alegre (HCPA) - PPDS
state: Rio Grande Do Sul
city: Santa Maria
country: Brazil
facility: Hospital Universitário de Santa Maria
state: Rio Grande Do Sul
city: Barretos
country: Brazil
facility: Fundação PIO XII
state: Sao Paulo
city: São Paulo
country: Brazil
facility: Hospital Alemão Oswaldo Cruz
state: Sao Paulo
city: São Paulo
country: Brazil
facility: Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
state: Sao Paulo
city: Toronto
country: Canada
facility: Toronto General Hospital
state: Ontario
city: Hong Kong
country: China
facility: Queen Mary Hospital
state: Hong Kong
city: Medellín
country: Colombia
facility: Hospital Pablo Tobón Uribe
city: Nice
country: France
facility: CHU de Nice
state: Alpes-Maritimes
city: Angers
country: France
facility: Hôtel Dieu -Angers
state: Maine-et-Loire
city: Lille
country: France
facility: Hôpital Claude Huriez
state: Nord
city: Caen
country: France
facility: Hopital Cote de Nacre
city: Paris
country: France
facility: Hôpital Saint Antoine
city: Athens
country: Greece
facility: Attikon University General Hospital
city: Athens
country: Greece
facility: Evangelismos General Hospital of Athens
city: Haifa
country: Israel
facility: Rambam Medical Center
city: Jerusalem
country: Israel
facility: Hadassah Medical Center
city: Ramat Gan
country: Israel
facility: Sheba Medical Center
city: Tel Aviv
country: Israel
facility: Tel Aviv Sourasky Medical Center
city: Brescia
country: Italy
facility: ASST degli Spedali Civili di Brescia - Spedali Civili di Brescia - INCIPIT - PIN
state: Lombardia
city: Ancona
country: Italy
facility: Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona-Umberto I G.M. Lancisi G. Salesi
state: Marche
city: Novara
country: Italy
facility: A.O.U. Maggiore della Carità
state: Piemonte
city: Vicenza
country: Italy
facility: Azienda ULSS 8 "Berica" - Ospedale San Bortolo
state: Veneto
city: Firenze
country: Italy
facility: Azienda Ospedaliera Universitaria Careggi
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario A Gemelli
city: Daejeon
country: Korea, Republic of
facility: Chungnam National University Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea, Seoul St. Mary's Hospital
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Ulsan
country: Korea, Republic of
facility: Gachon University Gil Medical Center
city: Mexico City
country: Mexico
facility: Instituto Nacional de Cancerologia
city: Gliwice
country: Poland
facility: Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy Oddzial w Gliwi
state: Slaskie
city: Gdańsk
country: Poland
facility: Uniwersyteckie Centrum Kliniczne
city: Pretoria
country: South Africa
facility: Albert Alberts Stem Cell Transplant Centre
state: Gauteng
city: Vereeniging
country: South Africa
facility: FCRN Clinical Trial Centre (Pty) Ldt
state: Gauteng
city: Johannesburg
country: South Africa
facility: WITS Clinical Research Site
city: Palma De Mallorca
country: Spain
facility: Hospital Universitario Son Espases
state: Baleares
city: L'Hospitalet De Llobregat
country: Spain
facility: ICO l'Hospitalet - Hospital Duran i Reynals
state: Barcelona
city: Cáceres
country: Spain
facility: Hospital de San Pedro de Alcantara
state: Caceres
city: El Palmar
country: Spain
facility: Hospital Universitario Virgen de La Arrixaca
state: Murcia
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona
city: Granada
country: Spain
facility: Hospital Universitario Virgen de Las Nieves
city: Madrid
country: Spain
facility: Hospital Universitario Ramon y Cajal
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Madrid
country: Spain
facility: Hospital Universitario La Paz - PPDS
city: Murcia
country: Spain
facility: Hospital General Universitario Morales Meseguer
city: Málaga
country: Spain
facility: Hospital Regional Universitario de Malaga - Hospital General
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocio - PPDS
city: Valencia
country: Spain
facility: Hospital Clinico Universitario de Valencia
city: Changhua
country: Taiwan
facility: Changhua Christian Medical Foundation Changhua Christian Hospital
city: Taipei City
country: Taiwan
facility: Taipei Veterans General Hospital
city: Bornova
country: Turkey
facility: Ege Universitesi Tip Fakultesi Hastanesi
state: Izmir
city: Tekirdağ
country: Turkey
facility: Namik Kemal University
state: Tekirdag
city: Samsun
country: Turkey
facility: Ondokuz Mayis Universitesi Tip Fakultesi Hastanesi
city: London
country: United Kingdom
facility: Imperial College
Study officials:
affiliation: Enanta Pharmaceuticals, Inc
name: Enanta Pharmaceuticals, Inc
role: STUDY_DIRECTOR
References: