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Virus Therapy
A Study to Assess EDP-938 for the Treatment of Acute Upper Respiratory Tract Infection With Respiratory Syncytial Virus in Adult Subjects (RSVP Trial)
Phase 2
Waitlist Available
Research Sponsored by Enanta Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up days 3, 5, 9 and 14
Summary
This trial tested an oral medicine called EDP-938 in adults with RSV-related upper respiratory infections. The goal was to see if it could reduce the severity and duration of the infection. The study included people with stable asthma or COPD.
Eligible Conditions
- Respiratory Syncytial Virus
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ days 3, 5, 9 and 14
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~days 3, 5, 9 and 14
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Total Symptom Score (TSS) Area Under the Curve (AUC)
Secondary study objectives
Number of Subjects With RSV RNA Viral Load Below Limit of Detection (LOD)
RSV RNA Viral Load Area Under the Curve (AUC)
Side effects data
From 2022 Phase 2 trial • 82 Patients • NCT041961015%
Urinary tract infection
5%
Diarrhoea
3%
Dyspepsia
3%
Blood creatine phosphokinase increased
3%
Alanine aminotransferase increased
3%
Anaemia
3%
Hepatic function abnormal
3%
Blood chloride decreased
3%
Blood cholesterol increased
3%
Urine ketone body present
3%
Headache
3%
Blood sodium decreased
3%
Protein total decreased
3%
Haemoptysis
3%
Leukocytosis
100%
80%
60%
40%
20%
0%
Study treatment Arm
EDP-938
Placebo
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: EDP-938Experimental Treatment1 Intervention
Subjects will take EDP-938 tablets (800 mg) once a day orally for 5 days
Group II: PlaceboPlacebo Group1 Intervention
Subjects will take EDP-938 matching placebo tablets once a day orally for 5 days
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
EDP-938
2021
Completed Phase 2
~510
Find a Location
Who is running the clinical trial?
PPD DEVELOPMENT, LPIndustry Sponsor
163 Previous Clinical Trials
37,233 Total Patients Enrolled
Enanta PharmaceuticalsLead Sponsor
33 Previous Clinical Trials
2,272 Total Patients Enrolled
PPDIndustry Sponsor
161 Previous Clinical Trials
36,309 Total Patients Enrolled
Enanta Pharmaceuticals, IncLead Sponsor
40 Previous Clinical Trials
3,039 Total Patients Enrolled
Nathalie Adda, MDStudy DirectorEnanta Pharmaceuticals, Inc
2 Previous Clinical Trials
251 Total Patients Enrolled
Scott Rottinghaus, MDStudy DirectorEnanta Pharmaceuticals, Inc