Safety and Efficacy of EDP1815 in the Treatment of Patients Hospitalized With COVID-19 Infection
NCT ID: NCT04488575
Last Updated: 2022-12-19
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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TERMINATED
PHASE2
16 participants
INTERVENTIONAL
2020-08-26
2021-05-19
Brief Summary
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Detailed Description
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The study is designed to evaluate the efficacy of EDP1815 at reducing time to resolution of symptoms, preventing progression of COVID-19 symptoms and preventing COVID-Related Complications (CRC)
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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EDP1815
Patients will receive EDP1815 in addition to standard of care
EDP1815
EDP1815 is an orally administered monoclonal microbe
Placebo
Patients will receive placebo in addition to standard of care
Placebo
Placebo oral capsule
Interventions
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EDP1815
EDP1815 is an orally administered monoclonal microbe
Placebo
Placebo oral capsule
Eligibility Criteria
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Inclusion Criteria
2. Receiving any form of supplementary oxygen therapy at baseline.
3. Confirmed COVID-19 viral infection by RTPCR at screening.
4. Age:
1. 18-65 years old, OR
2. \>65 year-olds can be included after Data Monitoring Committee (DMC) approval
Exclusion Criteria
2. Patients with chronic hypoxia or underlying significant chronic respiratory disease (such as Chronic Obstructive Pulmonary Disease (COPD), Pulmonary Fibrosis, or Bronchiectasis).
3. Admission to ICU at time of screening.
4. Mechanically ventilated, on continuous positive airway pressure (CPAP), or on non-invasive ventilation at the time of screening.
5. Patient is taking a systemic immunosuppressive agent such as, but not limited to, oral steroids, methotrexate, azathioprine, ciclosporin, or tacrolimus, unless these are given as part of COVID standard of care treatment.
6. Patient has a diagnosed primary immunodeficiency.
7. Patient has a diagnosis of HIV/AIDS
8. Patient has pre-existing known chronic kidney disease stage 4 or 5 or requiring renal replacement therapy (i.e. estimated glomerular filtration rate (eGFR) \<30ml/min/1.73m2)
9. Patient has pre-existing known significant liver disease with Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 5.0 x upper limit of normal (ULN)
10. Patient has pre-existing known significant gastrointestinal tract disease expected to affect absorption within the small intestine (e.g. short bowel syndrome, inflammatory bowel disease affecting the small intestine, gastroparesis); or prior malabsorptive bariatric surgery that could interfere with GI delivery and transit time.
11. GI signs or symptoms equivalent to CTCAE v5.0, gastrointestinal disorders, grade 3 or 4 event.
12. Patient has pre-existing known substantially impaired cardiac function or pre-existing clinically significant cardiac diseases, including unstable angina or acute myocardial infarction ≤ 6 weeks prior to Screening.
13. Currently participating in an interventional clinical trial (observational studies allowed).
14. Moribund at time of screening
18 Years
65 Years
ALL
No
Sponsors
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Evelo Biosciences, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Reynold Panettieri, MD
Role: PRINCIPAL_INVESTIGATOR
Rutgers, The State University of New Jersey
Douglas Maslin, MD
Role: STUDY_DIRECTOR
Evelo Biosciences
Locations
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Robert Wood Johnson University Hospital
New Brunswick, New Jersey, United States
The University Hospital
Newark, New Jersey, United States
DHR Health Institute
Edinburg, Texas, United States
Hacettepe University Adult Hospital
Ankara, , Turkey (Türkiye)
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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EDP1815-205
Identifier Type: -
Identifier Source: org_study_id