Zelicapavir is a novel, orally administered, nonfusion replication inhibitor of RSV. It is being investigated in this Phase 2 study (EDP 938-203) as a potential treatment for RSV infection in both hospitalized and non-hospitalized children aged ≥28 days to ≤36 months who present with symptomatic RSV infection.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
150
Oral suspension
Placebo oral suspension to match zelicapavir
Center of Excellence for Pediatric Infectious Diseases and Vaccines Faculty of Medicine, Chulalongkorn University (CE-PID)
Bangkok, Thailand
RECRUITINGNakornping Hospital
Chiang Mai, Thailand
RECRUITINGMaharaj Nakorn Chiang Mai Hospital
Chiang Mai, Thailand
RECRUITINGChiangrai Prachanukroh Hospital
Chiang Rai, Thailand
RECRUITINGKhon Kaen Hospital
Khon Kaen, Thailand
RECRUITINGLampang Hospital
Lampang, Thailand
RECRUITINGLamphun Hospital
Lamphun, Thailand
RECRUITINGMaha Sarakham Hospital
Maha Sarakham, Thailand
RECRUITINGTime to complete resolution of clinical signs of RSV as measured by RESOLVE-P
Time frame: Day 1 through Day 14
Time to sustained resolution of clinical signs of RSV as measured by RESOLVE-P
Time frame: Day 1 through Day 14
Change in severity of clinical signs of RSV from Baseline to D7 as measured by RESOLVE-P
Time frame: Day 1 through Day 7
Proportion of participants with Lower Respiratory Tract Infection (LRTI)
Time frame: D1 through D14
Change in severity of RSV from Baseline to D7 and D14
Time frame: Baseline to D7 and D14
Proportion of outpatient participants who were hospitalized due to RSV or other causes during the study period
Time frame: Day 1 through Day 35
Change in RSV viral load as measured by RT-qPCR
Time frame: Baseline to D7
Proportion of participants with viral load Target Not Detected (TND)
Time frame: Day 4, Day 7 and Day 14
Time to viral load TND
Time frame: Day 1 through Day 14
Plasma PK Concentrations of zelicapavir
Time frame: Up to Day 7
Safety as measured by frequency of adverse events (AEs)
Time frame: Up to Day 35
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