Effects of EDP-938 in Hematopoietic Cell Transplant Recipients Infected With Respiratory Syncytial Virus of the Upper Respiratory Tract
- Conditions
- Respiratory Syncytial Virus Infections
- Interventions
- Drug: PlaceboDrug: EDP-938
- Registration Number
- NCT04633187
- Lead Sponsor
- Enanta Pharmaceuticals, Inc
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 9
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo - EDP-938 EDP-938 -
- Primary Outcome Measures
Name Time Method Percentage of Subjects Who Develop Lower Respiratory Tract (LRTC) Complication Day 1 through Day 28
- Secondary Outcome Measures
Name Time Method Change From Baseline in RSV RNA Viral Load Day 1 through Day 49 Plasma PK Concentrations of EDP-938 800mg Day 1 Predose and Postdose, Day 4 Predose, Day 7 Predose and Postdose, Day 11 Predose, Day 16 Predose, Day 21 Predose and Postdose Proportion of Subjects Progressing to Respiratory Failure (of Any Cause) Requiring Mechanical Ventilation (Invasive or Noninvasive) or All-cause Mortality Day 1 through Day 49 Safety as Measured the Number of Participants With at Least One Treatment-emergent Adverse Event Day 1 through Day 49
Trial Locations
- Locations (64)
Augusta University Medical Center
🇺🇸Augusta, Georgia, United States
Evangelismos General Hospital of Athens
🇬🇷Athens, Greece
Ege Universitesi Tip Fakultesi Hastanesi
🇹🇷Bornova, Izmir, Turkey
Chronos Pesquisa Clínica
🇧🇷Brasília, Distrito Federal, Brazil
Hospital de Clinicas de Porto Alegre (HCPA) - PPDS
🇧🇷Porto Alegre, Rio Grande Do Sul, Brazil
Hôtel Dieu -Angers
🇫🇷Angers, Maine-et-Loire, France
Hospital Universitário de Santa Maria
🇧🇷Santa Maria, Rio Grande Do Sul, Brazil
Fundação PIO XII
🇧🇷Barretos, Sao Paulo, Brazil
Fundación Favaloro
🇦🇷Buenos Aires, Ciudad Autónoma De BuenosAires, Argentina
Hôpital de Jolimont
🇧🇪La Louvière, Belgium
Hospital Alemão Oswaldo Cruz
🇧🇷São Paulo, Sao Paulo, Brazil
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
🇧🇷São Paulo, Sao Paulo, Brazil
Toronto General Hospital
🇨🇦Toronto, Ontario, Canada
Queen Mary Hospital
🇨🇳Hong Kong, Hong Kong, China
Hopital Cote de Nacre
🇫🇷Caen, France
Hôpital Saint Antoine
🇫🇷Paris, France
ASST degli Spedali Civili di Brescia - Spedali Civili di Brescia - INCIPIT - PIN
🇮🇹Brescia, Lombardia, Italy
Tel Aviv Sourasky Medical Center
🇮🇱Tel Aviv, Israel
A.O.U. Maggiore della Carità
🇮🇹Novara, Piemonte, Italy
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
Fondazione Policlinico Universitario A Gemelli
🇮🇹Roma, Italy
Azienda Ospedaliera Universitaria Careggi
🇮🇹Firenze, Italy
Chungnam National University Hospital
🇰🇷Daejeon, Korea, Republic of
The Catholic University of Korea, Seoul St. Mary's Hospital
🇰🇷Seoul, Korea, Republic of
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of
Gachon University Gil Medical Center
🇰🇷Ulsan, Korea, Republic of
Albert Alberts Stem Cell Transplant Centre
🇿🇦Pretoria, Gauteng, South Africa
Uniwersyteckie Centrum Kliniczne
🇵🇱Gdańsk, Poland
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy Oddzial w Gliwi
🇵🇱Gliwice, Slaskie, Poland
WITS Clinical Research Site
🇿🇦Johannesburg, South Africa
ICO l'Hospitalet - Hospital Duran i Reynals
🇪🇸L'Hospitalet De Llobregat, Barcelona, Spain
Hospital Universitario Son Espases
🇪🇸Palma De Mallorca, Baleares, Spain
Hospital de San Pedro de Alcantara
🇪🇸Cáceres, Caceres, Spain
FCRN Clinical Trial Centre (Pty) Ldt
🇿🇦Vereeniging, Gauteng, South Africa
Hospital Universitario Virgen de La Arrixaca
🇪🇸El Palmar, Murcia, Spain
Hospital Clinic de Barcelona
🇪🇸Barcelona, Spain
Hospital Universitario Virgen de Las Nieves
🇪🇸Granada, Spain
Hospital Universitario La Paz - PPDS
🇪🇸Madrid, Spain
Hospital Universitario Ramon y Cajal
🇪🇸Madrid, Spain
Hospital Universitario 12 de Octubre
🇪🇸Madrid, Spain
Hospital General Universitario Morales Meseguer
🇪🇸Murcia, Spain
Hospital Regional Universitario de Malaga - Hospital General
🇪🇸Málaga, Spain
Hospital Clinico Universitario de Valencia
🇪🇸Valencia, Spain
Hospital Universitario Virgen del Rocio - PPDS
🇪🇸Sevilla, Spain
Changhua Christian Medical Foundation Changhua Christian Hospital
🇨🇳Changhua, Taiwan
Taipei Veterans General Hospital
🇨🇳Taipei City, Taiwan
Namik Kemal University
🇹🇷Tekirdağ, Tekirdag, Turkey
Imperial College
🇬🇧London, United Kingdom
Ondokuz Mayis Universitesi Tip Fakultesi Hastanesi
🇹🇷Samsun, Turkey
Hospital Britanico de Buenos Aires
🇦🇷Buenos Aires, Argentina
Instituto Fides
🇦🇷La Plata, Ciudad Autónoma De BuenosAires, Argentina
Hôpital Claude Huriez
🇫🇷Lille, Nord, France
Sanatorio Allende S.A.
🇦🇷Córdoba, Cordoba, Argentina
Instituto Nacional de Cancerologia
🇲🇽Mexico City, Mexico
Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona-Umberto I G.M. Lancisi G. Salesi
🇮🇹Ancona, Marche, Italy
Azienda ULSS 8 "Berica" - Ospedale San Bortolo
🇮🇹Vicenza, Veneto, Italy
Institute Jules Bordet
🇧🇪Anderlecht, Brussels, Belgium
Hospital Pablo Tobón Uribe
🇨🇴Medellín, Colombia
UZ Antwerpen
🇧🇪Edegem, Antwerpen, Belgium
Attikon University General Hospital
🇬🇷Athens, Greece
Rambam Medical Center
🇮🇱Haifa, Israel
Hadassah Medical Center
🇮🇱Jerusalem, Israel
CHU de Nice
🇫🇷Nice, Alpes-Maritimes, France
Sheba Medical Center
🇮🇱Ramat Gan, Israel