This is a Phase 2b, randomized, double-blind, placebo-controlled study of EDP-938 administered orally for the treatment of non-hospitalized adult subjects with confirmed RSV infection who are at high risk for complications after RSV infection.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
186
Time to resolution of RSV Lower Respiratory Tract Disease (LRTD) symptoms
Time frame: Day 1 through Day 33
Time to resolution of LRTD symptoms and 2 systemic symptoms
Time frame: Day 1 through Day 33
Time to resolution of all RSV symptoms
Time frame: Day 1 through Day 33
Change from Baseline in severity of RSV LRTD symptoms
Time frame: Day 1 through Day 33
Change from Baseline for impact scale
Time frame: Day 1 through Day 33
Time to resolution of Upper Respiratory Tract Disease congestion), LRTD, and 2 systemic symptoms
Time frame: Day 1 through Day 33
Time to no or mild impact of RSV disease on daily activities, emotions, and social relationships
Time frame: Day 1 through Day 33
Percentage of participants with post-baseline RSV-related complications
Time frame: Day 1 through Day 33
Time to improvement in RSV disease
Time frame: Day 1 through Day 33
Change from Baseline for Health-Related Quality of Life
Time frame: Day 1 through Day 33
Time to return to usual health
Time frame: Day 1 through Day 33
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Voyage Medical
Tempe, Arizona, United States
UCSF Fresno
Fresno, California, United States
Torrance Clinical Research Institute
Lomita, California, United States
Downtown LA Research Center Inc - ClinEdge - PPDS
Los Angeles, California, United States
Allianz Research Institute Inc
Westminster, California, United States
Allianz Research Institute - Colorado
Aurora, Colorado, United States
Bay Pines VA Healthcare System
Bay Pines, Florida, United States
C&A Clinical Trials Corp
Cape Coral, Florida, United States
Beautiful Minds Clinical Research Center
Cutler Bay, Florida, United States
Dinamo Research & Diagnostic center, LLC
Hialeah, Florida, United States
...and 74 more locations
Time to return to usual activities
Time frame: Day 1 through Day 33
Percentage of subjects requiring hospitalization for RSV or other causes;
Time frame: Day 1 through Day 33
Duration of hospitalization for RSV or other causes
Time frame: Day 1 through Day 33
All-cause mortality
Time frame: Day 1 through Day 33
RSV RNA viral load change from Baseline
Time frame: Days 3, 5, 9, and 14
Change in infectious RSV viral load over time
Time frame: Up to Day 14
Plasma PK Concentrations of EDP-938
Time frame: Up to Day 5
Safety as measured by frequency of adverse events (AEs)
Time frame: Up to Day 33