Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Enanta Pharmaceuticals, Inc
Age
18–64
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
Clareo Health | A Study to Evaluate EDP-235 in Non-hospitalized Adults With COVID-19
