A Study to Evaluate EDP-235 in Non-hospitalized Adults With COVID-19

Last updated: August 12, 2024
Sponsor: Enanta Pharmaceuticals, Inc
Overall Status: Completed

Phase

2

Condition

Covid-19

Treatment

Placebo

EDP-235

Clinical Study ID

NCT05616728
EDP 235-101
  • Ages 18-64
  • All Genders

Study Summary

Study of EDP-235 in Non-hospitalized Adults with Mild or Moderate COVID-19.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • SARS-CoV-2 infection confirmed by positive test ≤24 hours before randomization

  • COVID-19 symptom onset within 5 days prior to randomization and at least 2signs/symptoms attributable to COVID-19 present and one of at least moderateseverity at Screening

Exclusion

Exclusion Criteria:

  • Prior SARS-CoV-2 infection <90 days before enrollment and/or received any COVID-19vaccine dose <90 days before enrollment

  • Has one or more conditions associated with high risk for severe COVID-19

  • History of hospitalization for the medical treatment of COVID-19

  • Currently hospitalized or anticipated need for hospitalization in the clinicalopinion of the investigator

  • Known medical history of active liver disease

  • Receiving dialysis or have known moderate to severe renal impairment

  • Suspected or confirmed concurrent active systemic infection other than COVID-19 thatmay interfere with the evaluation of response to the study drug

  • Any comorbidity requiring hospitalization and/or surgery within 7 days before studyentry, or that is considered life threatening within 30 days before study entry

  • Known HIV infection with a HIV viral load greater than 400 copies/mL or medicationfor HIV treatment that is prohibited in this study based on medical history within 6months before the screening visit

  • History of hypersensitivity or other contraindication to any of the components ofthe study drug

  • Has received or is expected to receive pre-exposure prophylactic SARS-CoV-2 mAb

  • Has received or is expected to receive convalescent COVID-19 plasma

  • Oxygen saturation of ≤93% on room air obtained at rest within 24 hours beforerandomization

  • Participating in another interventional clinical study with an investigational agentor device, including those for COVID-19, within 30 days or five half-lives of theagent, whichever is longer, before signing the ICF

  • Females who are pregnant or breastfeeding

Study Design

Total Participants: 231
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 2
Study Start date:
November 10, 2022
Estimated Completion Date:
June 29, 2023

Connect with a study center

  • County Emergency Hospital

    Cluj-Napoca, Cluj 400347
    Romania

    Site Not Available

  • Cahaba Research Inc. - Birmingham

    Birmingham, Alabama 35242
    United States

    Site Not Available

  • Torrance Clinical Research Institute

    Lomita, California 90717
    United States

    Site Not Available

  • LA Universal Research Center, Inc.

    Los Angeles, California 90057
    United States

    Site Not Available

  • MedBio Trials - Miami

    Aventura, Florida 33180
    United States

    Site Not Available

  • Doral Medical Research

    Doral, Florida 33166
    United States

    Site Not Available

  • Encore Medical Research - Hollywood

    Hollywood, Florida 33021-6467
    United States

    Site Not Available

  • Universal Medical and Research Center, LLC

    Hollywood, Florida 33021
    United States

    Site Not Available

  • Advanced Research for Health Improvement, LLC

    Immokalee, Florida 34142
    United States

    Site Not Available

  • BioClinical Research Alliance

    Miami, Florida 33155-6542
    United States

    Site Not Available

  • C'A Medical Center Inc Research

    Miami, Florida 33174-2968
    United States

    Site Not Available

  • Continental Clinical Research, LLC

    Miami, Florida 33144
    United States

    Site Not Available

  • D&H National Research Centers

    Miami, Florida 33155
    United States

    Site Not Available

  • Dynamic Medical Research, LLC - Miami

    Miami, Florida 33144
    United States

    Site Not Available

  • Florida International Medical Research

    Miami, Florida 33155
    United States

    Site Not Available

  • LCC Medical Research - Miami - ClinEdge - PPDS

    Miami, Florida 33126-1921
    United States

    Site Not Available

  • Nuren Medical and Research Center

    Miami, Florida 33144
    United States

    Active - Recruiting

  • Reed Medical Research

    Miami, Florida 33176
    United States

    Site Not Available

  • US Associates in Research Inc

    Miami, Florida 33144
    United States

    Active - Recruiting

  • USPA Advance Concept Medical Research Group. LLC

    Miami, Florida 33143
    United States

    Site Not Available

  • IMIC Inc.

    Palmetto Bay, Florida 33157
    United States

    Site Not Available

  • CDC Research Institute, LLC

    Port Saint Lucie, Florida 34952-7536
    United States

    Site Not Available

  • Carolina Research Center

    Shelby, North Carolina 28150
    United States

    Site Not Available

  • Toledo Institute of Clinical Research

    Toledo, Ohio 43617
    United States

    Site Not Available

  • Frontier Clinical Research, LLC

    Smithfield, Pennsylvania 15478
    United States

    Site Not Available

  • Trio Clinical Trials LLC

    Houston, Texas 77008-1393
    United States

    Site Not Available

  • SMS Clinical Research, LLC

    Mesquite, Texas 75149
    United States

    Site Not Available

  • Epic Medical Research

    Red Oak, Texas 75154
    United States

    Site Not Available

  • Progressive Clinical Research LLC

    Bountiful, Utah 84010
    United States

    Site Not Available

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