Therapeutic: EDP-938, in clinical development as a potential treatment for RSV infection
Trial Status: Actively recruiting
Trial Information: The Phase 2b, randomized, double-blind, placebo-controlled, multi-center, global study is designed to evaluate the effect of EDP-938 compared with placebo on the progression of RSV infection by assessment of clinical symptoms. Approximately 180 patients will be treated with 800 mg of EDP-938 or placebo for five days and evaluated for 28 days thereafter.
The study will include non-hospitalized adults with up to 72 hours of respiratory tract infection symptoms who test positive for RSV and negative for influenza virus and SARS-CoV-2. To be included in the study, the patient must have at least one of the following conditions that predispose them to complications after RSV infection: age ≥65 years, congestive heart failure (CHF), asthma or chronic obstructive pulmonary disease (COPD). The patient must have a new onset of any of the following symptom(s) or worsening of preexisting symptom(s) consistent with a respiratory tract infection no more than 72 hours prior to the administration of the first dose of study drug: feeling feverish, headache, neck pain, fatigue, loss of appetite, interrupted sleep, body aches, sore throat, nasal congestion, cough, cough with phlegm, wheezing, or short of breath. The patient must have at least two of the following symptoms, one of which must be reported as at least ‘moderate’ severity: cough, cough with phlegm, wheezing, or short of breath.
The primary endpoint of the study is time to resolution of RSV lower respiratory tract disease symptoms as assessed by the Respiratory Infection Intensity and Impact Questionnaire (RiiQ™) symptom scale through Day 33. Additional secondary endpoints include additional clinical efficacy measures and antiviral activity compared to placebo, pharmacokinetics, and safety of EDP-938.
For more information, visit ClinicalTrials.gov Identifier: NCT05568706