A Study of EDP-938 in Non-hospitalized Adults With RSV Who Are at High Risk for Complications.
- Registration Number
- NCT05568706
- Lead Sponsor
- Enanta Pharmaceuticals, Inc
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 186
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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)
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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.
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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
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The subject has tested positive for RSV infection using a NAAT (polymerase chain reaction [PCR] or other) on a nasal/nasopharyngeal swab sample.
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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.
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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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Matching placebo, once daily EDP-938 EDP-938 EDP-938 800 mg, once daily
- Primary Outcome Measures
Name Time Method Time to resolution of RSV Lower Respiratory Tract Disease (LRTD) symptoms Day 1 through Day 33
- Secondary Outcome Measures
Name Time Method Time to resolution of Upper Respiratory Tract Disease congestion), LRTD, and 2 systemic symptoms Day 1 through Day 33 Change from Baseline in severity of RSV LRTD symptoms Day 1 through Day 33 Time to return to usual health Day 1 through Day 33 Time to resolution of all RSV symptoms Day 1 through Day 33 Change from Baseline for impact scale Day 1 through Day 33 Change from Baseline for Health-Related Quality of Life Day 1 through Day 33 Percentage of subjects requiring hospitalization for RSV or other causes; Day 1 through Day 33 All-cause mortality Day 1 through Day 33 Change in infectious RSV viral load over time Up to Day 14 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 Safety as measured by frequency of adverse events (AEs) Up to Day 33 Time to return to usual activities Day 1 through Day 33 Duration of hospitalization for RSV or other causes Day 1 through Day 33 RSV RNA viral load change from Baseline Days 3, 5, 9, and 14 Plasma PK Concentrations of EDP-938 Up to Day 5 Time to resolution of LRTD symptoms and 2 systemic symptoms Day 1 through Day 33
Trial Locations
- Locations (84)
Voyage Medical
🇺🇸Tempe, Arizona, United States
UCSF Fresno
🇺🇸Fresno, California, United States
Torrance Clinical Research Institute
🇺🇸Lomita, California, United States
Downtown LA Research Center Inc - ClinEdge - PPDS
🇺🇸Los Angeles, California, United States
Allianz Research Institute Inc
🇺🇸Westminster, California, United States
Allianz Research Institute - Colorado
🇺🇸Aurora, Colorado, United States
Bay Pines VA Healthcare System
🇺🇸Bay Pines, Florida, United States
C&A Clinical Trials Corp
🇺🇸Cape Coral, Florida, United States
Beautiful Minds Clinical Research Center
🇺🇸Cutler Bay, Florida, United States
Dinamo Research & Diagnostic center, LLC
🇺🇸Hialeah, Florida, United States
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