A Study to Evaluate EDP-235 in Non-hospitalized Adults With COVID-19
Completed · Phase 2 · Has a placebo group
Conditions studied: COVID-19
In brief
Study of EDP-235 in Non-hospitalized Adults with Mild or Moderate COVID-19.
Key facts
- Study ID
- NCT05616728
- Run by
- Enanta Pharmaceuticals, Inc
- People needed
- 231
- Starts
- 2022-11-10
- Expected to finish
- 2023-06-29
- Last updated by the study team
- 2024-08-19
Who can join
Age: 18 and older, up to 64. Sex: any. Healthy volunteers: not accepted.
You may qualify 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 qualify 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
Where it is running
- 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
- Dynamic Medical Research, LLC - Miami — Miami, Florida, United States
- BioClinical Research Alliance — Miami, Florida, United States
- D&H National Research Centers — Miami, Florida, United States
- Florida International Medical Research — Miami, Florida, United States
- C'A Medical Center Inc Research — Miami, Florida, United States
- Reed Medical Research — Miami, Florida, United States
- CDC Research Institute, LLC — Port Saint Lucie, Florida, United States
- Carolina Research Center — Shelby, North Carolina, United States
- Toledo Institute of Clinical Research — Toledo, Ohio, United States
- Trio Clinical Trials LLC — Houston, Texas, United States
- SMS Clinical Research, LLC — Mesquite, Texas, United States
- Epic Medical Research — Red Oak, Texas, United States
- County Emergency Hospital — Cluj-Napoca, Cluj, Romania
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.