Phase 2
Completed N=231
A Study to Evaluate EDP-235 in Non-hospitalized Adults With COVID-19
Source: ClinicalTrials.gov NCT05616728 ↗Enrolled (actual)
231
Serious AEs
0.0%
Results posted
Aug 2024
Primary outcomePrimary: Number of Adverse Events as a Measure of Safety and Tolerability — 1; 6; 3 Number of Adverse Events
Summary
Study of EDP-235 in Non-hospitalized Adults with Mild or Moderate COVID-19.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Adverse Events as a Measure of Safety and Tolerability |
1; 6; 3 | — |
| SECONDARY Change From Baseline in SARS-CoV-2 RNA Viral Load |
-1.664; -1.626; -1.500; -3.048; -3.465; -3.340 | — |
| SECONDARY Change From Baseline in Infectious SARS- CoV-2 Viral Load |
-0.743; -0.836; -0.705; -0.872; -1.065; -0.982 | — |
| SECONDARY Proportion of Participants With COVID-19 Signs/Symptom Improvement |
56; 61; 51 | — |
| SECONDARY Change From Baseline in COVID-19 Signs/Symptom |
-12.8; -14.0; -12.8 | — |
| SECONDARY Proportion of Participants With Medically Attended Visits for COVID-19 |
0; 0; 0 | — |
| SECONDARY Proportion of Participants Requiring Hospitalization for COVID-19 |
0; 0; 0 | — |
| SECONDARY Proportion of Participants All-cause Mortality |
0; 0; 0 | — |
| SECONDARY Proportion of Participants Who Require Hospitalization and Mechanical Ventilation |
0; 0; 0 | — |
| SECONDARY Mean Plasma PK Concentrations of EDP-235 |
571; 902; 1050; 2250; 1290; 2230 | — |
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
Data sourced from ClinicalTrials.gov (NCT05616728). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.