A Study of EDP-938 in Non-hospitalized Adults with RSV Who Are At High Risk for Complications.
a study on RSV
Summary
- Eligibility
- for people ages 18 years and up (full criteria)
- Location
- at UCSF
- Dates
- study startedcompletion around
Description
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.
Official Title
A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of EDP-938 in Non-hospitalized Adults with Acute Respiratory Syncytial Virus Infection Who Are At High Risk for Complications
Keywords
RSV Infection, High Risk, Respiratory Syncytial Virus, Infections, Respiratory Syncytial Virus Infections, EDP-938
Eligibility
You can join if…
Open to people ages 18 years and up
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.
You CAN'T join if...
- 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
Locations
- UCSF Fresno
accepting new patients
Fresno California 93701 United States - Velocity Clinical Research
withdrawn
Los Angeles California 90057 United States - Downtown LA Research Center Inc - ClinEdge - PPDS
accepting new patients
Los Angeles California 90017 United States - Allianz Research Institute Inc
accepting new patients
Westminster California 92683 United States - Ascada Research LLC
accepting new patients
Fullerton California 92835-3424 United States - Torrance Clinical Research Institute
completed
Lomita California 90717 United States - Capitis Medical And Aesthetics
withdrawn
Roseville California 95678-2474 United States
Details
- Status
- accepting new patients
- Start Date
- Completion Date
- (estimated)
- Sponsor
- Enanta Pharmaceuticals, Inc
- ID
- NCT05568706
- Phase
- Phase 2 RSV Research Study
- Study Type
- Interventional
- Participants
- Expecting 180 study participants
- Last Updated