A Study to Evaluate EDP-235 in Non-hospitalized Adults With COVID-19
NCT ID: NCT05616728
Last Updated: 2024-08-19
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
231 participants
INTERVENTIONAL
2022-11-10
2023-06-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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EDP-235 200mg
Once a day orally for 5 days
EDP-235
capsule
EDP-235 400mg
Once a day orally for 5 days
EDP-235
capsule
Placebo
Once a day orally for 5 days
Placebo
capsule
Interventions
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EDP-235
capsule
Placebo
capsule
Eligibility Criteria
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Inclusion Criteria
* COVID-19 symptom onset within 5 days prior to randomization and at least 2 signs/symptoms attributable to COVID-19 present and one of at least moderate severity at Screening
Exclusion Criteria
* 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 clinical opinion 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 that may interfere with the evaluation of response to the study drug
* Any comorbidity requiring hospitalization and/or surgery within 7 days before study entry, 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 medication for HIV treatment that is prohibited in this study based on medical history within 6 months before the screening visit
* History of hypersensitivity or other contraindication to any of the components of the 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 before randomization
* Participating in another interventional clinical study with an investigational agent or device, including those for COVID-19, within 30 days or five half-lives of the agent, whichever is longer, before signing the ICF
* Females who are pregnant or breastfeeding
18 Years
64 Years
ALL
No
Sponsors
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Enanta Pharmaceuticals, Inc
INDUSTRY
Responsible Party
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Principal Investigators
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Enanta Pharmaceuticals, Inc
Role: STUDY_DIRECTOR
Enanta Pharmaceuticals, Inc
Locations
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Torrance Clinical Research Institute
Lomita, California, United States
LA Universal Research Center, Inc.
Los Angeles, California, United States
MedBio Trials - Miami
Aventura, Florida, United States
Doral Medical Research
Doral, Florida, United States
Encore Medical Research - Hollywood
Hollywood, Florida, United States
Universal Medical and Research Center, LLC
Hollywood, Florida, United States
Advanced Research for Health Improvement, LLC
Immokalee, Florida, United States
LCC Medical Research - Miami - ClinEdge - PPDS
Miami, Florida, United States
USPA Advance Concept Medical Research Group. LLC
Miami, Florida, United States
Continental Clinical Research, LLC
Miami, Florida, United States
Dynamic Medical Research, LLC - Miami
Miami, Florida, United States
BioClinical Research Alliance
Miami, Florida, United States
D&H National Research Centers
Miami, Florida, United States
Florida International Medical Research
Miami, Florida, United States
C'A Medical Center Inc Research
Miami, Florida, United States
Reed Medical Research
Miami, Florida, United States
CDC Research Institute, LLC
Port Saint Lucie, Florida, United States
Carolina Research Center
Shelby, North Carolina, United States
Toledo Institute of Clinical Research
Toledo, Ohio, United States
Trio Clinical Trials LLC
Houston, Texas, United States
SMS Clinical Research, LLC
Mesquite, Texas, United States
Epic Medical Research
Red Oak, Texas, United States
County Emergency Hospital
Cluj-Napoca, Cluj, Romania
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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EDP 235-101
Identifier Type: -
Identifier Source: org_study_id
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