Therapeutic: EDP-938, in clinical development as a potential treatment for RSV infection
Trial Status: Actively recruiting
Trial Information: RSVPEDs is a Phase 2, randomized double-blind, placebo-controlled, dose-ranging study to evaluate EDP-938 in hospitalized or non-hospitalized infants and children aged 28 days to 36 months who test positive for RSV.
Approximately 90 patients aged 28 days to 36 months who test positive for RSV will be enrolled. To be included in the study, patients must have one or more signs of an acute respiratory illness (e.g. fever or symptoms of fever, cough, nasal congestion, runny nose, rapid breathing, shortness of breath, or wheezing) with onset of 7 days or less (Part 1) or 5 days or less (Part 2) before the time of signing the informed consent form.
The study has two parts, with the primary objective of Part 1 being to evaluate safety and pharmacokinetics. The primary objective of Part 2 is to evaluate antiviral activity as measured by the change in RSV shedding in nasopharyngeal swab samples determined using quantitative RT-PCR.
To visit the clinical trial website for RSVPEDs, click here
For more information, visit ClinicalTrials.gov Identifier: NCT04816721