Therapeutic: EDP-938, in clinical development as a potential treatment for RSV infection
Trial Status: Actively Recruiting
Trial Information: RSVTx is a Phase 2b randomized, double-blind, placebo-controlled study evaluating the efficacy and safety of EDP-938 in adult hematopoietic cell transplant (HCT) recipients with acute RSV infection and symptoms of acute upper respiratory tract infection.
Approximately 200 adult subjects 18 Years to 75 years within 72 hours of symptom onset will be enrolled. Symptoms may include 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. To be included in the study, patients must have received an autologous or allogeneic HCT using any conditioning regimen and have an absolute lymphocyte count (ALC) less than 500 cells/ µL.
The primary objective of the study is theeffect of EDP-938 on development of lower respiratory tract complications in HCT subjects with acute RSV upper respiratory tract infection. The secondary objective of the study is to evaluate viral load and progression to respiratory failure, as well as pharmacokinetics and safety.
For more information, visit ClinicalTrials.gov Identifier: NCT04633187