SPRINT: A Study to Evaluate EDP-235 in Non-hospitalized Adults With COVID-19
Study Details
Study Description
Brief Summary
Study of EDP-235 in Non-hospitalized Adults with Mild or Moderate COVID-19.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 2 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: EDP-235 200mg Once a day orally for 5 days |
Drug: EDP-235
capsule
|
Experimental: EDP-235 400mg Once a day orally for 5 days |
Drug: EDP-235
capsule
|
Placebo Comparator: Placebo Once a day orally for 5 days |
Drug: Placebo
capsule
|
Outcome Measures
Primary Outcome Measures
- Safety as measured by frequency of adverse events (AEs) [Day 1 through Day 33]
Secondary Outcome Measures
- Change from baseline in SARS-CoV-2 RNA viral load [Day 1 through Day 14]
- Change from baseline in infectious SARS- CoV-2 viral load [Day 1 through 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]
- Proportion of participants requiring hospitalization for COVID-19 [Day 1 through Day 33]
- Proportion of participants all-cause mortality [Day 1 through Day 33]
- Proportion of participants who require hospitalization and mechanical ventilation [Day 1 through Day 33]
- Plasma PK Concentrations of EDP-235 [Day 1 through Day 5]
Eligibility Criteria
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
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Cahaba Research Inc. - Birmingham | Birmingham | Alabama | United States | 35242 |
2 | Torrance Clinical Research Institute | Lomita | California | United States | 90717 |
3 | LA Universal Research Center, Inc. | Los Angeles | California | United States | 90057 |
4 | MedBio Trials - Miami | Aventura | Florida | United States | 33180 |
5 | Doral Medical Research | Doral | Florida | United States | 33166 |
6 | Universal Medical and Research Center, LLC | Hollywood | Florida | United States | 33021 |
7 | Advanced Research for Health Improvement, LLC | Immokalee | Florida | United States | 34142 |
8 | USPA Advance Concept Medical Research Group. LLC | Miami | Florida | United States | 33143 |
9 | Continental Clinical Research, LLC | Miami | Florida | United States | 33144 |
10 | Nuren Medical and Research Center | Miami | Florida | United States | 33144 |
11 | US Associates in Research Inc | Miami | Florida | United States | 33144 |
12 | D&H National Research Centers | Miami | Florida | United States | 33155 |
13 | Florida International Medical Research | Miami | Florida | United States | 33155 |
14 | Reed Medical Research | Miami | Florida | United States | 33176 |
15 | IMIC Inc. | Palmetto Bay | Florida | United States | 33157 |
16 | Carolina Research Center | Shelby | North Carolina | United States | 28150 |
17 | Toledo Institute of Clinical Research | Toledo | Ohio | United States | 43617 |
18 | Frontier Clinical Research, LLC | Smithfield | Pennsylvania | United States | 15478 |
19 | SMS Clinical Research, LLC | Mesquite | Texas | United States | 75149 |
20 | Epic Medical Research | Red Oak | Texas | United States | 75154 |
21 | Progressive Clinical Research LLC | Bountiful | Utah | United States | 84010 |
Sponsors and Collaborators
- Enanta Pharmaceuticals, Inc
Investigators
- Study Director: Enanta Pharmaceuticals, Inc, Enanta Pharmaceuticals, Inc
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- EDP 235-101