A Study to Evaluate EDP-235 in Non-hospitalized Adults With COVID-19 (SPRINT)
COVID-19
About this trial
This is an interventional treatment trial for COVID-19 focused on measuring SARS-CoV-2, Standard Risk
Eligibility Criteria
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 2 signs/symptoms attributable to COVID-19 present and one of at least moderate severity at Screening Exclusion Criteria: Prior SARS-CoV-2 infection <90 days before enrollment and/or received any COVID-19 vaccine 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 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
Sites / Locations
- Cahaba Research Inc. - BirminghamRecruiting
- Torrance Clinical Research Institute
- LA Universal Research Center, Inc.Recruiting
- MedBio Trials - MiamiRecruiting
- Doral Medical ResearchRecruiting
- Universal Medical and Research Center, LLCRecruiting
- Advanced Research for Health Improvement, LLCRecruiting
- USPA Advance Concept Medical Research Group. LLCRecruiting
- Continental Clinical Research, LLCRecruiting
- Nuren Medical and Research CenterRecruiting
- US Associates in Research IncRecruiting
- D&H National Research CentersRecruiting
- Florida International Medical ResearchRecruiting
- Reed Medical ResearchRecruiting
- IMIC Inc.Recruiting
- Carolina Research CenterRecruiting
- Toledo Institute of Clinical ResearchRecruiting
- Frontier Clinical Research, LLC
- SMS Clinical Research, LLCRecruiting
- Epic Medical ResearchRecruiting
- Progressive Clinical Research LLCRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Placebo Comparator
EDP-235 200mg
EDP-235 400mg
Placebo
Once a day orally for 5 days
Once a day orally for 5 days
Once a day orally for 5 days