A Study to Assess EDP-938 for the Treatment of Acute Upper Respiratory Tract Infection With Respiratory Syncytial Virus in Adult Subjects (RSVP)
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|ClinicalTrials.gov Identifier: NCT04196101|
Recruitment Status : Recruiting
First Posted : December 12, 2019
Last Update Posted : October 5, 2021
|Condition or disease||Intervention/treatment||Phase|
|Respiratory Syncytial Virus||Drug: EDP-938 Drug: Placebo||Phase 2|
Subjects (aged 18 to 75 years, inclusive) with up to 48 hours of upper respiratory tract infection (URTI) symptoms who test positive for respiratory syncytial virus (RSV) and negative for influenza virus by rapid testing (ie, Rapid Viral Screen). Subjects with stable asthma or chronic obstructive pulmonary disease (COPD) will be allowed in the study.
Approximately 70 subjects will be enrolled in this Phase 2b, randomized, double-blind, placebo-controlled, multicentre study of EDP-938 administered orally for the treatment of acute URTI with confirmed RSV infection in ambulatory adult subjects.
For each subject, the duration of study participation will be approximately 2 weeks and will consist of 3 periods: Screening (occurs on Day1), Treatment (5 days), and Follow-up (9 days after last dose).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||70 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Study of EDP-938 Administered Orally for the Treatment of Acute Upper Respiratory Tract Infection With Respiratory Syncytial Virus in Ambulatory Adult Subjects (RSVP)|
|Actual Study Start Date :||January 22, 2020|
|Estimated Primary Completion Date :||April 2022|
|Estimated Study Completion Date :||April 2022|
Subjects will take EDP-938 tablets (800 mg) once a day orally for 5 days
Four tablets daily for 5 days
Placebo Comparator: Placebo
Subjects will take EDP-938 matching placebo tablets once a day orally for 5 days
Four tablets daily for 5 days
- Total Symptom Score of clinical symptoms [ Time Frame: Day 1 through Day 14 ]
- RSV RNA Viral Load [ Time Frame: Day 1 through Day 14 ]
- Safety as measured by frequency of adverse events (AEs) [ Time Frame: Day 1 through Day 14 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04196101
|Contact: Guy De La Rosa, MDfirstname.lastname@example.org|
|Study Director:||Nathalie Adda, MD||Enanta Pharmaceuticals Inc.|