Effects of EDP-938 in Hematopoietic Cell Transplant Recipients Infected With Respiratory Syncytia… (NCT04633187) | Clinical Trial Compass
TerminatedPhase 2
Effects of EDP-938 in Hematopoietic Cell Transplant Recipients Infected With Respiratory Syncytial Virus of the Upper Respiratory Tract
Stopped: Study was terminated due to a strategic business decision and not due to safety concerns.
United States, Argentina9 participantsStarted 2021-07-07
Plain-language 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.
Who can participate
Age range16 Years – 75 Years
SexALL
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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 wit…
What they're measuring
1
Percentage of Subjects Who Develop Lower Respiratory Tract (LRTC) Complication