Last updated 25 days ago
A Study of EDP-938 in Non-hospitalized Adults with RSV Who Are At High Risk for Complications.
180 patients around the world
Available in Puerto Rico, Spain, United States, Argentina, Brazil
Enanta Pharmaceuticals, Inc
3Research sites
180Patients around the world
Requirements for the patient
From 18 Years
All Gender
Medical requirements
- At least one of the following conditions that predispose them to complications after RSV infection: 1. Age ≥65 years 2. Congestive heart failure (CHF) 3. Asthma 4. 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 breathThe 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.
- The subject has an anticipated need for hospitalization within 24 hours of signing the Study ICFThe subject receives systemic antiviral, antibacterial, antifungal, or antimycobacterial therapy within 7 days prior to signing the Study ICFThe 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 ICFThe subject has a SARS-CoV-2 test result that is positive within 28 days prior to signing the Study ICFThe 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 prolongationThe subject has immunocompromised statusThe 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
Sites
L2IP Instituto de Pesquisas Clínicas
Recruiting
CPClin – Centro de Pesquisas Clinicas LTDA
Recruiting
Caribbean Pulmonary Medical Society
Recruiting
StudyRSVHR
SponsorEnanta Pharmaceuticals, Inc
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT05568706
