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NCT04196101 · ClinicalTrials.gov registry record · Phase 2
A Study to Assess EDP-938 for the Treatment of Acute Upper Respiratory Tract Infection With Respiratory Syncytial Virus in Adult Subjects
A Phase 2 study of Respiratory Syncytial Virus, sponsored by Enanta Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 82
- Enrollment target
- 20
- Study locations
NCT04196101: Completed Phase 2 study of Respiratory Syncytial Virus, sponsored by Enanta Pharmaceuticals.
NCT04196101 is a Phase 2 study of Respiratory Syncytial Virus that has completed, run by Enanta Pharmaceuticals. The registered enrollment target is 82 participants, below the 385-participant average among 7 other Respiratory Syncytial Virus trials with a reported enrollment target (79% lower). The trial reports 20 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04196101, a Phase 2 study of Respiratory Syncytial Virus, has completed, sponsored by Enanta Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 82 participants
- Enrollment target
- 20
- Study locations
Study Summary
This was a randomized, double-blind, placebo-controlled, multicentre, phase 2 study to evaluate the efficacy, safety and tolerability of orally administered EDP-938 in adults with RSV infection.
Primary Outcome
Assessed by the RSV Symptom Diary, including 13 items assessing the severity of RSV-related signs and symptoms. The diary uses a 4-point scale that consists of grading symptoms on a scale of 0 to 3 for each item, where Grade 0 is Absent, Grade 1 is Noticeable, Grade 2 is Bothersome but not preventing activity, and Grade 3 is Bothersome and interfering with activities. TSS is derived daily by summing of the 13 observed symptom grade values from Day 1 through Day 14 to generate the curve for analy
Conditions Studied
Interventions
- DRUG Placebo
- DRUG EDP-938
Study Locations (20)
Other
- Instituto Medico Platense - Buenos Aires
- Multiprofile Hospital for Active Treatment Puls - Blagoevgrad
- Specialized Hospital for Active Treatment of Pneumophthisiatric Diseases - Haskovo EOOD - Haskovo
- Medical Center Zdrave-1 OOD - Kozloduy
- Medical Center Tara OOD - Veliko Tarnovo
- Lakeland Clinical Trials - Waikato - Hamilton
North Carolina
- Carolina Research Center - Shelby
- PMG Research of Wilmington - Wilmington
- Progressive Medicine of the Triad, LLC - Winston-Salem
Alabama
- Central Alabama Research - Birmingham
- Cahaba Research Inc. - Birmingham - Pelham
California
- Saint Joseph's Clinical Research - Anaheim
- Torrance Clinical Research Institute - Lomita
Nebraska
- Pioneer Clinical Research LLC - Bellevue
- Meridian Clinical Research - Norfolk
Sofia-Grad
- Diagnostic and Consulting Center Aleksandrovska EOOD - Sofia
- Medical Center Hera - Sofia
Florida
- Miami Clinical Research - ClinEdge - PPDS - Miami
Nevada
- Clinical Research of South Nevada - Las Vegas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 82 participants |
| Start Date | 2020-01-22 |
| Est. Completion | 2022-01-04 |
| Phase | Phase 2 |
What the finished NCT04196101 record still lists
NCT04196101 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 82 participants, a relatively small participant target, below the 385-participant average among 7 other Respiratory Syncytial Virus trials with a reported enrollment target (79% lower).
The record links to 1 condition, with Respiratory Syncytial Virus appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT04196101 names 20 study sites across 9 states, led by Other, North Carolina, Alabama.
Frequently Asked Questions
What is clinical trial NCT04196101 about?
NCT04196101 is a clinical study titled "A Study to Assess EDP-938 for the Treatment of Acute Upper Respiratory Tract Infection With Respiratory Syncytial Virus in Adult Subjects". This was a randomized, double-blind, placebo-controlled, multicentre, phase 2 study to evaluate the efficacy, safety and tolerability of orally administered EDP-938 in adults with RSV infection.
What is the current status of trial NCT04196101?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 82 participants. The study started on 2020-01-22. Estimated completion is 2022-01-04.
What conditions does trial NCT04196101 study?
This clinical trial studies the following conditions: Respiratory Syncytial Virus.
What interventions are being tested in trial NCT04196101?
The interventions under investigation include: Placebo (DRUG), EDP-938 (DRUG).
Who is sponsoring clinical trial NCT04196101?
This trial is sponsored by Enanta Pharmaceuticals, which has 36 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04196101 being conducted?
This trial has 20 study locations across Alabama, California, Florida, Nebraska, Nevada. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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