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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
9
Percentage of Subjects Who Develop Lower Respiratory Tract (LRTC) Complication
Time frame: Day 1 through Day 28
Change From Baseline in RSV RNA Viral Load
Time frame: Day 1 through Day 49
Proportion of Subjects Progressing to Respiratory Failure (of Any Cause) Requiring Mechanical Ventilation (Invasive or Noninvasive) or All-cause Mortality
Time frame: Day 1 through Day 49
Safety as Measured the Number of Participants With at Least One Treatment-emergent Adverse Event
Time frame: Day 1 through Day 49
Plasma PK Concentrations of EDP-938 800mg
Time frame: Day 1 Predose and Postdose, Day 4 Predose, Day 7 Predose and Postdose, Day 11 Predose, Day 16 Predose, Day 21 Predose and Postdose
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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, 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
...and 54 more locations