A Study to Evaluate EDP-235 in Non-hospitalized Adults With COVID-19
SPRINT
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
1 other identifier
interventional
231
2 countries
23
Brief Summary
Study of EDP-235 in Non-hospitalized Adults with Mild or Moderate COVID-19.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 covid19
Started Nov 2022
23 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 9, 2022
CompletedStudy Start
First participant enrolled
November 10, 2022
CompletedFirst Posted
Study publicly available on registry
November 15, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 8, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
June 29, 2023
CompletedResults Posted
Study results publicly available
August 19, 2024
CompletedAugust 19, 2024
May 1, 2024
3 months
November 9, 2022
May 24, 2024
August 12, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Adverse Events as a Measure of Safety and Tolerability
Day 1 through Day 33
Secondary Outcomes (9)
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 COVID-19 Signs/Symptom Improvement
Day 1 through Day 33
Change From Baseline in COVID-19 Signs/Symptom
Day 1 through Day 33
Proportion of Participants With Medically Attended Visits for COVID-19
Day 1 through Day 33
- +4 more secondary outcomes
Study Arms (3)
EDP-235 200mg
EXPERIMENTALOnce a day orally for 5 days
EDP-235 400mg
EXPERIMENTALOnce a day orally for 5 days
Placebo
PLACEBO COMPARATOROnce a day orally for 5 days
Interventions
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (23)
Torrance Clinical Research Institute
Lomita, California, 90717, United States
LA Universal Research Center, Inc.
Los Angeles, California, 90057, United States
MedBio Trials - Miami
Aventura, Florida, 33180, United States
Doral Medical Research
Doral, Florida, 33166, United States
Encore Medical Research - Hollywood
Hollywood, Florida, 33021-6467, United States
Universal Medical and Research Center, LLC
Hollywood, Florida, 33021, United States
Advanced Research for Health Improvement, LLC
Immokalee, Florida, 34142, United States
LCC Medical Research - Miami - ClinEdge - PPDS
Miami, Florida, 33126-1921, United States
USPA Advance Concept Medical Research Group. LLC
Miami, Florida, 33143, United States
Continental Clinical Research, LLC
Miami, Florida, 33144, United States
Dynamic Medical Research, LLC - Miami
Miami, Florida, 33144, United States
BioClinical Research Alliance
Miami, Florida, 33155-6542, United States
D&H National Research Centers
Miami, Florida, 33155, United States
Florida International Medical Research
Miami, Florida, 33155, United States
C'A Medical Center Inc Research
Miami, Florida, 33174-2968, United States
Reed Medical Research
Miami, Florida, 33176, United States
CDC Research Institute, LLC
Port Saint Lucie, Florida, 34952-7536, United States
Carolina Research Center
Shelby, North Carolina, 28150, United States
Toledo Institute of Clinical Research
Toledo, Ohio, 43617, United States
Trio Clinical Trials LLC
Houston, Texas, 77008-1393, United States
SMS Clinical Research, LLC
Mesquite, Texas, 75149, United States
Epic Medical Research
Red Oak, Texas, 75154, United States
County Emergency Hospital
Cluj-Napoca, Cluj, 400347, Romania
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Justin Aubin
- Organization
- Enanta Pharmaceuticals, Inc.
Study Officials
- STUDY DIRECTOR
Enanta Pharmaceuticals, Inc
Enanta Pharmaceuticals, Inc
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 9, 2022
First Posted
November 15, 2022
Study Start
November 10, 2022
Primary Completion
February 8, 2023
Study Completion
June 29, 2023
Last Updated
August 19, 2024
Results First Posted
August 19, 2024
Record last verified: 2024-05