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Spartanburg Medical Research | Spartanburg, SC

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

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Enanta Pharmaceuticals

Status and phase

Enrolling
Phase 2

Conditions

RSV Infection

Treatments

Drug: EDP-938
Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT05568706
EDP 938-104

Details and patient eligibility

About

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.

Enrollment

180 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

180 participants in 2 patient groups, including a placebo group

EDP-938
Experimental group
Description:
EDP-938 800 mg, once daily
Treatment:
Drug: EDP-938
Placebo
Placebo Comparator group
Description:
Matching placebo, once daily
Treatment:
Drug: Placebo

Trial contacts and locations

116

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Central trial contact

Enanta Pharmaceuticals, Inc

Data sourced from clinicaltrials.gov

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