A Study to Evaluate EDP-235 in Non-hospitalized Adults With COVID-19
- Registration Number
- NCT05616728
- Lead Sponsor
- Enanta Pharmaceuticals, Inc
- Brief Summary
Study of EDP-235 in Non-hospitalized Adults with Mild or Moderate COVID-19.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 231
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Once a day orally for 5 days EDP-235 200mg EDP-235 Once a day orally for 5 days EDP-235 400mg EDP-235 Once a day orally for 5 days
- Primary Outcome Measures
Name Time Method Number of Adverse Events as a Measure of Safety and Tolerability Day 1 through Day 33
- Secondary Outcome Measures
Name Time Method Change From Baseline in SARS-CoV-2 RNA Viral Load Day 3, Day 5, Day 9 and Day 14 Change From Baseline in Infectious SARS- CoV-2 Viral Load Day 3, Day 5, Day 9 and Day 14 Proportion of Participants With Medically Attended Visits for COVID-19 Day 1 through Day 33 Proportion of Participants With COVID-19 Signs/Symptom Improvement Day 1 through Day 33 Proportion of Participants Who Require Hospitalization and Mechanical Ventilation Day 1 through Day 33 Proportion of Participants All-cause Mortality Day 1 through Day 33 Change From Baseline in COVID-19 Signs/Symptom Day 1 through Day 33 The total score is computed as the sum across all 14 COVID-19 symptom severity scores for each visit. Total scores range from 0 to 42; higher scores indicate more severe symptoms. For symptom score, 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe for each symptom.
Proportion of Participants Requiring Hospitalization for COVID-19 Day 1 through Day 33 Mean Plasma PK Concentrations of EDP-235 Day 1 through Day 5
Trial Locations
- Locations (23)
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
Scroll for more (13 remaining)Torrance Clinical Research Institute🇺🇸Lomita, California, United States