Clinical trial NCT05616728: A Study to Evaluate EDP-235 in Non-hospitalized Adults With COVID-19
Official title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Effects of EDP-235 in Non-hospitalized Adults With Mild or Moderate COVID-19
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: COVID-19
Keywords: SARS-CoV-2, Standard Risk
Lead sponsor: Enanta Pharmaceuticals, Inc
Sponsor class: INDUSTRY
First posted: 2022-11-15
Enrollment: 231
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: Number of Adverse Events as a Measure of Safety and Tolerability
timeFrame: Day 1 through Day 33
Secondary outcomes:
measure: Change From Baseline in SARS-CoV-2 RNA Viral Load
timeFrame: Day 3, Day 5, Day 9 and Day 14
measure: Change From Baseline in Infectious SARS- CoV-2 Viral Load
timeFrame: Day 3, Day 5, Day 9 and Day 14
measure: Proportion of Participants With COVID-19 Signs/Symptom Improvement
timeFrame: Day 1 through Day 33
measure: Change From Baseline in COVID-19 Signs/Symptom
timeFrame: Day 1 through Day 33
measure: Proportion of Participants With Medically Attended Visits for COVID-19
timeFrame: Day 1 through Day 33
measure: Proportion of Participants Requiring Hospitalization for COVID-19
timeFrame: Day 1 through Day 33
measure: Proportion of Participants All-cause Mortality
timeFrame: Day 1 through Day 33
measure: Proportion of Participants Who Require Hospitalization and Mechanical Ventilation
timeFrame: Day 1 through Day 33
measure: Mean Plasma PK Concentrations of EDP-235
timeFrame: Day 1 through Day 5
Other outcomes:
Locations:
city: Lomita
country: United States
facility: Torrance Clinical Research Institute
state: California
city: Los Angeles
country: United States
facility: LA Universal Research Center, Inc.
state: California
city: Aventura
country: United States
facility: MedBio Trials - Miami
state: Florida
city: Doral
country: United States
facility: Doral Medical Research
state: Florida
city: Hollywood
country: United States
facility: Encore Medical Research - Hollywood
state: Florida
city: Hollywood
country: United States
facility: Universal Medical and Research Center, LLC
state: Florida
city: Immokalee
country: United States
facility: Advanced Research for Health Improvement, LLC
state: Florida
city: Miami
country: United States
facility: LCC Medical Research - Miami - ClinEdge - PPDS
state: Florida
city: Miami
country: United States
facility: USPA Advance Concept Medical Research Group. LLC
state: Florida
city: Miami
country: United States
facility: Continental Clinical Research, LLC
state: Florida
city: Miami
country: United States
facility: Dynamic Medical Research, LLC - Miami
state: Florida
city: Miami
country: United States
facility: BioClinical Research Alliance
state: Florida
city: Miami
country: United States
facility: D&H National Research Centers
state: Florida
city: Miami
country: United States
facility: Florida International Medical Research
state: Florida
city: Miami
country: United States
facility: C'A Medical Center Inc Research
state: Florida
city: Miami
country: United States
facility: Reed Medical Research
state: Florida
city: Port Saint Lucie
country: United States
facility: CDC Research Institute, LLC
state: Florida
city: Shelby
country: United States
facility: Carolina Research Center
state: North Carolina
city: Toledo
country: United States
facility: Toledo Institute of Clinical Research
state: Ohio
city: Houston
country: United States
facility: Trio Clinical Trials LLC
state: Texas
city: Mesquite
country: United States
facility: SMS Clinical Research, LLC
state: Texas
city: Red Oak
country: United States
facility: Epic Medical Research
state: Texas
city: Cluj-Napoca
country: Romania
facility: County Emergency Hospital
state: Cluj
Study officials:
affiliation: Enanta Pharmaceuticals, Inc
name: Enanta Pharmaceuticals, Inc
role: STUDY_DIRECTOR
References: