Effects of EDP-938 in Hematopoietic Cell Transplant Recipients Infected With Respiratory Syncytial Virus of the Upper Respiratory Tract

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Respiratory Syncytial Virus Infections

In brief

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.

Key facts

Study ID

NCT04633187

Run by

Enanta Pharmaceuticals, Inc

People needed

9

Starts

2021-07-07

Expected to finish

2023-05-31

Last updated by the study team

2024-08-22

Who can join

Age: 16 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Fundación Favaloro — Buenos Aires, Ciudad Autónoma de BuenosAires, Argentina
• Instituto Fides — La Plata, Ciudad Autónoma de BuenosAires, Argentina
• Sanatorio Allende S.A. — Córdoba, Córdoba Province, Argentina
• Hospital Britanico de Buenos Aires — Buenos Aires, Argentina
• UZ Antwerpen — Edegem, Antwerpen, Belgium
• Institute Jules Bordet — Anderlecht, Brussels Capital, Belgium
• Hôpital de Jolimont — La Louvière, Belgium
• Chronos Pesquisa Clínica — Brasília, Federal District, Brazil
• Hospital de Clinicas de Porto Alegre (HCPA) - PPDS — Porto Alegre, Rio Grande do Sul, Brazil
• Hospital Universitário de Santa Maria — Santa Maria, Rio Grande do Sul, Brazil
• Fundação PIO XII — Barretos, São Paulo, Brazil
• Hospital Alemão Oswaldo Cruz — São Paulo, São Paulo, Brazil
• Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo — São Paulo, São Paulo, Brazil
• Toronto General Hospital — Toronto, Ontario, Canada
• Queen Mary Hospital — Hong Kong, Hong Kong, China
• Hospital Pablo Tobón Uribe — Medellín, Colombia
• CHU de Nice — Nice, Alpes-Maritimes, France
• Hôtel Dieu -Angers — Angers, Maine-et-Loire, France
• Hôpital Claude Huriez — Lille, Nord, France
• Hopital Cote de Nacre — Caen, France
• Hôpital Saint Antoine — Paris, France
• Attikon University General Hospital — Athens, Greece
• Evangelismos General Hospital of Athens — Athens, Greece
• Rambam Medical Center — Haifa, Israel
• Augusta University Medical Center — Augusta, Georgia, United States

Full record on ClinicalTrials.gov

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