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

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

Inclusion Criteria:SARS-CoV-2 infection confirmed by positive test ≤24 hours before randomizationCOVID-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 ScreeningExclusion Criteria:Prior SARS-CoV-2 infection <90 days before enrollment and/or received any COVID-19 vaccine dose <90 days before enrollmentHas one or more conditions associated with high risk for severe COVID-19History of hospitalization for the medical treatment of COVID-19Currently hospitalized or anticipated need for hospitalization in the clinical opinion of the investigatorKnown medical history of active liver diseaseReceiving dialysis or have known moderate to severe renal impairmentSuspected or confirmed concurrent active systemic infection other than COVID-19 that may interfere with the evaluation of response to the study drugAny comorbidity requiring hospitalization and/or surgery within 7 days before study entry, or that is considered life threatening within 30 days before study entryKnown 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 visitHistory of hypersensitivity or other contraindication to any of the components of the study drugHas received or is expected to receive pre-exposure prophylactic SARS-CoV-2 mAbHas received or is expected to receive convalescent COVID-19 plasmaOxygen saturation of ≤93% on room air obtained at rest within 24 hours before randomizationParticipating 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 ICFFemales who are pregnant or breastfeeding