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

Phase 2

Terminated

• Conditions: Respiratory Syncytial Virus Infections
• Interventions: Drug: Placebo; Drug: 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

Study Timeline

• Study First Submitted: 2020-11-11
• Study First Submitted QC: 2020-11-11
• Study First Posted: 2020-11-18
• Study Start: 2021-07-07
• Primary Completion: 2023-05-31
• Study Completion: 2023-05-31
• Status Verified: 2024-07
• Results First Submitted: 2024-07-15
• Results First Submitted QC: 2024-08-20
• Last Update Submitted: 2024-08-20
• Results First Posted: 2024-08-22
• Last Update Posted: 2024-08-22

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 9

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.

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

Fundación Favaloro; 🇦🇷 Buenos Aires, Ciudad Autónoma De BuenosAires, Argentina

Instituto Fides; 🇦🇷 La Plata, Ciudad Autónoma De BuenosAires, Argentina

Sanatorio Allende S.A.; 🇦🇷 Córdoba, Cordoba, Argentina

Hospital Britanico de Buenos Aires; 🇦🇷 Buenos Aires, Argentina

UZ Antwerpen; 🇧🇪 Edegem, Antwerpen, Belgium

Institute Jules Bordet; 🇧🇪 Anderlecht, Brussels, Belgium

Hôpital de Jolimont; 🇧🇪 La Louvière, Belgium

Chronos Pesquisa Clínica; 🇧🇷 Brasília, Distrito Federal, Brazil

Hospital de Clinicas de Porto Alegre (HCPA) - PPDS; 🇧🇷 Porto Alegre, Rio Grande Do Sul, Brazil

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