COVID-19Phase 2SPRINTNCT05616728
A Study to Evaluate EDP-235 in Non-hospitalized Adults With COVID-19
A Phase 2 study testing EDP-235 in people with COVID-19, run by Enanta Pharmaceuticals, Inc at 23 sites in 2 countries.
Trial summary
Study of EDP-235 in Non-hospitalized Adults with Mild or Moderate COVID-19. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- COVID-19
- What is being tested?
- EDP-235
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 231 participants
- Where
- 23 sitesin 2 countries
- Study dates
- 10 Nov 2022to 29 Jun 2023
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
23 sites in 2 countries.
23 sites in 2 countries
United States22 sites
MedBio Trials - Miami
Aventura, Florida, 33180
Doral Medical Research
Doral, Florida, 33166
Encore Medical Research - Hollywood
Hollywood, Florida, 33021-6467
Universal Medical and Research Center, LLC
Hollywood, Florida, 33021
Trio Clinical Trials LLC
Houston, Texas, 77008-1393
Advanced Research for Health Improvement, LLC
Immokalee, Florida, 34142
Torrance Clinical Research Institute
Lomita, California, 90717
LA Universal Research Center, Inc.
Los Angeles, California, 90057
SMS Clinical Research, LLC
Mesquite, Texas, 75149
LCC Medical Research - Miami - ClinEdge - PPDS
Miami, Florida, 33126-1921
USPA Advance Concept Medical Research Group. LLC
Miami, Florida, 33143
Continental Clinical Research, LLC
Miami, Florida, 33144
Dynamic Medical Research, LLC - Miami
Miami, Florida, 33144
BioClinical Research Alliance
Miami, Florida, 33155-6542
D&H National Research Centers
Miami, Florida, 33155
Florida International Medical Research
Miami, Florida, 33155
C'A Medical Center Inc Research
Miami, Florida, 33174-2968
Reed Medical Research
Miami, Florida, 33176
CDC Research Institute, LLC
Port Saint Lucie, Florida, 34952-7536
Epic Medical Research
Red Oak, Texas, 75154
Carolina Research Center
Shelby, North Carolina, 28150
Toledo Institute of Clinical Research
Toledo, Ohio, 43617
About this study
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 of EDP-235 in Non-hospitalized Adults with Mild or Moderate COVID-19.
- Conditions
- COVID-19
- Being tested
- EDP-235, Placebo
- Keywords
- SARS-CoV-2, Standard Risk
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EDP-235Drug
capsule
PlaceboDrug
capsule
| Study group | Role | What they receive |
|---|---|---|
| EDP-235 200mg | Experimental | Once a day orally for 5 days Receives: Drug: EDP-235 |
| EDP-235 400mg | Experimental | Once a day orally for 5 days Receives: Drug: EDP-235 |
| Placebo | Placebo comparator | Once a day orally for 5 days Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Adverse Events as a Measure of Safety and Tolerability
Measured: Day 1 through Day 33
Secondary outcomes (9)
Change From Baseline in SARS-CoV-2 RNA Viral Load
Measured: Day 3, Day 5, Day 9 and Day 14
Change From Baseline in Infectious SARS- CoV-2 Viral Load
Measured: Day 3, Day 5, Day 9 and Day 14
Proportion of Participants With COVID-19 Signs/Symptom Improvement
Measured: Day 1 through Day 33
Change From Baseline in COVID-19 Signs/Symptom
The total score is computed as the sum across all 14 COVID-19 symptom severity scores for each visit. Total scores range from 0 to 42; higher scores indicate more severe symptoms. For symptom score, 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe for each symptom.
Measured: Day 1 through Day 33
Proportion of Participants With Medically Attended Visits for COVID-19
Measured: Day 1 through Day 33
Proportion of Participants Requiring Hospitalization for COVID-19
Measured: Day 1 through Day 33
Proportion of Participants All-cause Mortality
Measured: Day 1 through Day 33
Proportion of Participants Who Require Hospitalization and Mechanical Ventilation
Measured: Day 1 through Day 33
Mean Plasma PK Concentrations of EDP-235
Measured: Day 1 through Day 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2022
- Study start10 Nov 2022
- Primary completion8 Feb 2023
- Study completion29 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 231 participants (actual)
Sponsor and investigators
- Lead sponsor
- Enanta Pharmaceuticals, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Enanta Pharmaceuticals, Inc, Study director, Enanta Pharmaceuticals, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05616728
- Sponsor's protocol ID
- EDP 235-101
- Acronym
- SPRINT
- Status last verified
- May 2024
- First submitted
- 9 Nov 2022
- Last updated
- 19 Aug 2024
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05616728
- Acronym / sponsor ID
- SPRINT / EDP 235-101
- Conditions
- COVID-19
- Keywords
- SARS-CoV-2, Standard Risk
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 231 participants (actual)
- Lead sponsor
- Enanta Pharmaceuticals, IncIndustry (pharma, biotech, devices)
- Study start
- 10 Nov 2022 (actual)
- Primary completion
- 8 Feb 2023 (actual)
- Study completion
- 29 Jun 2023 (actual)
- First posted
- 15 Nov 2022 (actual)
- Results
- Posted 19 Aug 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study of EDP-235 in Non-hospitalized Adults with Mild or Moderate COVID-19.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| EDP-235 200mg | Experimental | Drug: EDP-235Once a day orally for 5 days |
| EDP-235 400mg | Experimental | Drug: EDP-235Once a day orally for 5 days |
| Placebo | Placebo comparator | Drug: PlaceboOnce a day orally for 5 days |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EDP-235capsule | Drug | EDP-235 200mg, EDP-235 400mg |
| Placebocapsule | Drug | Placebo |
Primary outcome
Number of Adverse Events as a Measure of Safety and Tolerability
Time frame: Day 1 through Day 33
9 secondary outcomes
Change From Baseline in SARS-CoV-2 RNA Viral Load
Time frame: Day 3, Day 5, Day 9 and Day 14
Change From Baseline in Infectious SARS- CoV-2 Viral Load
Time frame: Day 3, Day 5, Day 9 and Day 14
Proportion of Participants With COVID-19 Signs/Symptom Improvement
Time frame: Day 1 through Day 33
Change From Baseline in COVID-19 Signs/Symptom
Time frame: Day 1 through Day 33
Proportion of Participants With Medically Attended Visits for COVID-19
Time frame: Day 1 through Day 33
Proportion of Participants Requiring Hospitalization for COVID-19
Time frame: Day 1 through Day 33
Proportion of Participants All-cause Mortality
Time frame: Day 1 through Day 33
Proportion of Participants Who Require Hospitalization and Mechanical Ventilation
Time frame: Day 1 through Day 33
Mean Plasma PK Concentrations of EDP-235
Time frame: Day 1 through Day 5
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Enanta Pharmaceuticals, Inc study director
Enanta Pharmaceuticals, Inc
23 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing EDP-235 in people with COVID-19, run by Enanta Pharmaceuticals, Inc at 23 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in United States, Romania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Adverse Events as a Measure of Safety and Tolerability (time frame: Day 1 through Day 33). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2024.