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 Fresno, California and other locations
- 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 - Capitis Medical And Aesthetics
withdrawn
Roseville California 95678-2474 United States - Downtown LA Research Center Inc - ClinEdge - PPDS
accepting new patients
Los Angeles California 90017 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
Frequently Asked Questions
Please contact me about this study
We will not share your information with anyone other than the team in charge of this study, which might include an external sponsor. Submitting your contact information does not obligate you to participate in research.
Thank you!
The study team should get back to you in a few business days.
You will also receive an email with next steps. Check your junk/spam folder if needed.
If you do not hear from the study team, please call 888-689-8273 and tell them you’re interested in study number NCT05568706.