COMPLETED

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

Conditions

RSV Infection High Risk, Respiratory Syncytial Virus

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Quick Facts

Study Start:2022-11-29

Study Completion:2025-06-23

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT05568706

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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

Inclusion Criteria

Exclusion 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.

* 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

Contacts and Locations

Principal Investigator

Enanta Pharmaceuticals, Inc

STUDY_DIRECTOR

Enanta Pharmaceuticals, Inc

Study Locations (Sites)

Voyage Medical

Tempe, Arizona, 85282-2455

United States

UCSF Fresno

Fresno, California, 93701

United States

Torrance Clinical Research Institute

Lomita, California, 90717

United States

Downtown LA Research Center Inc - ClinEdge - PPDS

Los Angeles, California, 90017

United States

Allianz Research Institute Inc

Westminster, California, 92683

United States

Allianz Research Institute - Colorado

Aurora, Colorado, 80014

United States

Bay Pines VA Healthcare System

Bay Pines, Florida, 33744

United States

C&A Clinical Trials Corp

Cape Coral, Florida, 33990

United States

Beautiful Minds Clinical Research Center

Cutler Bay, Florida, 33157

United States

Dinamo Research & Diagnostic center, LLC

Hialeah, Florida, 33015

United States

I.H.S Health LLC

Kissimmee, Florida, 34741

United States

Dynamic Medical Research, LLC

Miami, Florida, 33144

United States

Floridian Research Institute

Miami, Florida, 33179-2537

United States

Orlando VA Healthcare System

Orlando, Florida, 32827

United States

Ormond Beach Clinical Research

Ormond Beach, Florida, 32174

United States

CDC Research Institute, LLC

Port Saint Lucie, Florida, 34952

United States

Research Bay, Inc.

Tampa, Florida, 33607

United States

Santos Research Center

Tampa, Florida, 33615

United States

Covenant Pulmonary Criticial Care and Research Ins

East Point, Georgia, 30344

United States

Snake River Research

Idaho Falls, Idaho, 83404

United States

University of Louisville

Louisville, Kentucky, 40202

United States

Mercury Street Medical

Butte, Montana, 59701

United States

Global Health Institute

Syracuse, New York, 13210-1685

United States

Progressive Medicine of the Triad, LLC

Winston-Salem, North Carolina, 27103

United States

Toledo Institute of Clinical Research

Toledo, Ohio, 43617

United States

IMA Clinical Research - Austin - PPDS

Austin, Texas, 78704-7507

United States

Valley Institute of Research

Fort Worth, Texas, 76164-9041

United States

HDH Research, Inc.

Houston, Texas, 77022

United States

Metroplex Pulmonary and Sleep Medicine Center-4833 Medical Center Dr Unit 6B

McKinney, Texas, 75069

United States

SMS Clinical Research, LLC

Mesquite, Texas, 75149

United States

Eastside Research Associates

Redmond, Washington, 98052

United States

Collaborators and Investigators

Sponsor: Enanta Pharmaceuticals, Inc

Enanta Pharmaceuticals, Inc, STUDY_DIRECTOR, Enanta Pharmaceuticals, Inc

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-11-29

Study Completion Date2025-06-23

Study Record Updates

Study Start Date2022-11-29

Study Completion Date2025-06-23

Terms related to this study

Keywords Provided by Researchers

High Risk, Respiratory Syncytial Virus

Additional Relevant MeSH Terms

RSV Infection