Phase
Condition
Covid-19
Treatment
Placebo
EDP-235
Clinical Study ID
Ages 18-64 All Genders
Study Summary
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
Connect with a study center
County Emergency Hospital
Cluj-Napoca, Cluj 400347
RomaniaSite Not Available
Cahaba Research Inc. - Birmingham
Birmingham, Alabama 35242
United StatesSite Not Available
Torrance Clinical Research Institute
Lomita, California 90717
United StatesSite Not Available
LA Universal Research Center, Inc.
Los Angeles, California 90057
United StatesSite Not Available
MedBio Trials - Miami
Aventura, Florida 33180
United StatesSite Not Available
Doral Medical Research
Doral, Florida 33166
United StatesSite Not Available
Encore Medical Research - Hollywood
Hollywood, Florida 33021-6467
United StatesSite Not Available
Universal Medical and Research Center, LLC
Hollywood, Florida 33021
United StatesSite Not Available
Advanced Research for Health Improvement, LLC
Immokalee, Florida 34142
United StatesSite Not Available
BioClinical Research Alliance
Miami, Florida 33155-6542
United StatesSite Not Available
C'A Medical Center Inc Research
Miami, Florida 33174-2968
United StatesSite Not Available
Continental Clinical Research, LLC
Miami, Florida 33144
United StatesSite Not Available
D&H National Research Centers
Miami, Florida 33155
United StatesSite Not Available
Dynamic Medical Research, LLC - Miami
Miami, Florida 33144
United StatesSite Not Available
Florida International Medical Research
Miami, Florida 33155
United StatesSite Not Available
LCC Medical Research - Miami - ClinEdge - PPDS
Miami, Florida 33126-1921
United StatesSite Not Available
Nuren Medical and Research Center
Miami, Florida 33144
United StatesActive - Recruiting
Reed Medical Research
Miami, Florida 33176
United StatesSite Not Available
US Associates in Research Inc
Miami, Florida 33144
United StatesActive - Recruiting
USPA Advance Concept Medical Research Group. LLC
Miami, Florida 33143
United StatesSite Not Available
IMIC Inc.
Palmetto Bay, Florida 33157
United StatesSite Not Available
CDC Research Institute, LLC
Port Saint Lucie, Florida 34952-7536
United StatesSite Not Available
Carolina Research Center
Shelby, North Carolina 28150
United StatesSite Not Available
Toledo Institute of Clinical Research
Toledo, Ohio 43617
United StatesSite Not Available
Frontier Clinical Research, LLC
Smithfield, Pennsylvania 15478
United StatesSite Not Available
Trio Clinical Trials LLC
Houston, Texas 77008-1393
United StatesSite Not Available
SMS Clinical Research, LLC
Mesquite, Texas 75149
United StatesSite Not Available
Epic Medical Research
Red Oak, Texas 75154
United StatesSite Not Available
Progressive Clinical Research LLC
Bountiful, Utah 84010
United StatesSite Not Available
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