RSVHR: A Study of EDP-938 in Non-hospitalized Adults With RSV Who Are at High Risk for Complications.
Study Details
Study Description
Brief Summary
This is a Phase 2b, randomized, double-blind, placebo-controlled study of EDP-938 administered orally for the treatment of non-hospitalized adult subjects with confirmed RSV infection who are at high risk for complications after RSV infection.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: EDP-938 EDP-938 800 mg, once daily |
Drug: EDP-938
Subjects will take EDP-938 once daily for 5 days
|
| Placebo Comparator: Placebo Matching placebo, once daily |
Drug: Placebo
Subjects will take matching placebo, once daily for 5 days
|
Outcome Measures
Primary Outcome Measures
- Time to resolution of RSV Lower Respiratory Tract Disease (LRTD) symptoms [Day 1 through Day 33]
Secondary Outcome Measures
- Time to resolution of LRTD symptoms and 2 systemic symptoms [Day 1 through Day 33]
- Time to resolution of all RSV symptoms [Day 1 through Day 33]
- Change from Baseline in severity of RSV LRTD symptoms [Day 1 through Day 33]
- Change from Baseline for impact scale [Day 1 through Day 33]
- Time to resolution of Upper Respiratory Tract Disease congestion), LRTD, and 2 systemic symptoms [Day 1 through Day 33]
- Time to no or mild impact of RSV disease on daily activities, emotions, and social relationships [Day 1 through Day 33]
- Percentage of participants with post-baseline RSV-related complications [Day 1 through Day 33]
- Time to improvement in RSV disease [Day 1 through Day 33]
- Change from Baseline for Health-Related Quality of Life [Day 1 through Day 33]
- Time to return to usual health [Day 1 through Day 33]
- Time to return to usual activities [Day 1 through Day 33]
- Percentage of subjects requiring hospitalization for RSV or other causes; [Day 1 through Day 33]
- Duration of hospitalization for RSV or other causes [Day 1 through Day 33]
- All-cause mortality [Day 1 through Day 33]
- RSV RNA viral load change from Baseline [Days 3, 5, 9, and 14]
- Change in infectious RSV viral load over time [Up to Day 14]
- Plasma PK Concentrations of EDP-938 [Up to Day 5]
- Safety as measured by frequency of adverse events (AEs) [Up to Day 33]
Eligibility Criteria
Criteria
Inclusion Criteria:
- At least one of the following conditions that predispose them to complications after
RSV infection:
-
Age ≥65 years
-
Congestive heart failure (CHF)
-
Asthma
-
Chronic obstructive pulmonary disease (COPD)
-
The subject has a new onset of any of the following symptom(s) or worsening of pre-existing 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 subject reports at least 2 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 subject has tested positive for RSV infection using a NAAT (polymerase chain reaction [PCR] or other) on a nasal/nasopharyngeal swab sample.
-
A woman of childbearing potential who is sexually active with a male must agree to use two effective methods of contraception from the date of Screening until 30 days after her last dose of study drug.
-
A male subject who has not had a vasectomy and is sexually active with a woman of childbearing potential must agree to use effective contraception from the date of Screening to 90 days after his last dose of study drug.
Exclusion Criteria:
-
The subject has an anticipated need for hospitalization within 24 hours of signing the Study ICF
-
The subject receives systemic antiviral, antibacterial, antifungal, or antimycobacterial therapy within 7 days prior to signing the Study ICF
-
The subject has concomitant respiratory infections that are viral (other than RSV but including influenza), bacterial, or fungal, including systemic bacterial or fungal infections, within 7 days prior to signing the Study ICF
-
The subject has a SARS-CoV-2 test result that is positive within 28 days prior to signing the Study ICF
-
The subject has COPD with spirometry results (obtained within 1 year prior to signing the Study ICF) FEV1 ≤35%
-
The subject has a known positive human immunodeficiency virus infection, active hepatitis A virus infection, chronic hepatitis B virus infection, and/or current hepatitis C virus (HCV) infection; subjects with a history of HCV infection who have achieved a documented sustained virologic response 12 weeks after completion of HCV therapy may be enrolled.
-
The subject has any of the following cardiac conditions: any congenital heart disease, congenital long QT syndrome, or any clinical manifestation resulting in QT interval prolongation
-
The subject has immunocompromised status
-
The subject is living in institutional care or assisted living facility and is also receiving acute care management for any respiratory condition; Note: Independent living apartments are not considered institutional care or assisted living facility
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Velocity Clinical Research | Westlake | California | United States | 90057 |
| 2 | Allianz Research Institute | Denver | Colorado | United States | 80219 |
| 3 | San Marcus Research Clinic Inc | Miami | Florida | United States | 33014 |
| 4 | Dynamic Medical Research, LLC | Miami | Florida | United States | 33183 |
| 5 | Florida Institute For Clinical Research LLC | Orlando | Florida | United States | 32825 |
| 6 | Ormond Beach Clinical Research | Ormond Beach | Florida | United States | 32174 |
| 7 | Del Pilar Medical and Urgent Care | Mishawaka | Indiana | United States | 46545 |
| 8 | Medical Arts Research Center | Madison Heights | Michigan | United States | 48071 |
| 9 | Nebraska Medical Research Institute, Inc | Bellevue | Nebraska | United States | 68123 |
| 10 | Progressive Medicine of the Triad, LLC | Winston-Salem | North Carolina | United States | 27103 |
| 11 | Toledo Institute of Clinical Research | Toledo | Ohio | United States | 43617 |
| 12 | Main Street Physicians Care | Little River | South Carolina | United States | 29566 |
| 13 | Spartanburg Medical Research | Spartanburg | South Carolina | United States | 29303 |
| 14 | Inquest Clinical Research | Baytown | Texas | United States | 77521 |
Sponsors and Collaborators
- Enanta Pharmaceuticals, Inc
Investigators
- Study Director: Enanta Pharmaceuticals, Inc, Enanta Pharmaceuticals, Inc
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- EDP 938-104