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A Study of EDP-938 in Non-hospitalized Adults With RSV Who Are at High Risk for Complications.
A Study of EDP-938 in Non-hospitalized Adults With RSV Who Are at High Risk for Complications.

NCT05568706

CompletedPhase 2

Sponsor: Enanta Pharmaceuticals, Inc

Conditions: RSV Infection

Interventions: EDP-938, Placebo

Countries: United States, Argentina, Bulgaria, Colombia, Czechia, Malaysia, Mexico, Poland

This was 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 were at high risk for complications after RSV infection.

Eligibility overview

Sex: ALL

Age: 18 Years to

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
Inclusion Criteria:

* 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 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 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 (84)
  • Tempe, Arizona, United States
  • Fresno, California, United States
  • Lomita, California, United States
  • Los Angeles, California, United States
  • Westminster, California, United States
  • Aurora, Colorado, United States
  • Bay Pines, Florida, United States
  • Cape Coral, Florida, United States
  • Cutler Bay, Florida, United States
  • Hialeah, Florida, United States
  • Kissimmee, Florida, United States
  • Miami, Florida, United States
  • Miami, Florida, United States
  • Orlando, Florida, United States
  • Ormond Beach, Florida, United States
  • Port Saint Lucie, Florida, United States
  • Tampa, Florida, United States
  • Tampa, Florida, United States
  • East Point, Georgia, United States
  • Idaho Falls, Idaho, United States
  • Louisville, Kentucky, United States
  • Butte, Montana, United States
  • Syracuse, New York, United States
  • Winston-Salem, North Carolina, United States
  • Toledo, Ohio, United States
  • Austin, Texas, United States
  • Fort Worth, Texas, United States
  • Houston, Texas, United States
  • McKinney, Texas, United States
  • Mesquite, Texas, United States
  • + 54 more on CT.gov