Status:
TERMINATED
Safety and Efficacy of EDP1815 in the Treatment of Patients Hospitalized With COVID-19 Infection
Lead Sponsor:
Evelo Biosciences, Inc.
Conditions:
Covid19
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
Evelo will investigate the safety and efficacy of EDP1815 in the treatment of patients hospitalized with SARS-CoV-2 Infection
Detailed Description
This is a randomized, placebo-controlled clinical study to assess the safety and efficacy of EDP1815 in patients hospitalized with COVID-19 infection. The study is designed to evaluate the efficacy o...
Eligibility Criteria
Inclusion
- Key
- Hospitalized within the last 36 hours.
- Receiving any form of supplementary oxygen therapy at baseline.
- Confirmed COVID-19 viral infection by RTPCR at screening.
- Age:
- 18-65 years old, OR
- \>65 year-olds can be included after Data Monitoring Committee (DMC) approval
- Key
Exclusion
- Contraindications/hypersensitivity to P histicola or any of the capsule excipients
- Patients with chronic hypoxia or underlying significant chronic respiratory disease (such as Chronic Obstructive Pulmonary Disease (COPD), Pulmonary Fibrosis, or Bronchiectasis).
- Admission to ICU at time of screening.
- Mechanically ventilated, on continuous positive airway pressure (CPAP), or on non-invasive ventilation at the time of screening.
- 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.
- Patient has a diagnosed primary immunodeficiency.
- Patient has a diagnosis of HIV/AIDS
- 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)
- Patient has pre-existing known significant liver disease with Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 5.0 x upper limit of normal (ULN)
- 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.
- GI signs or symptoms equivalent to CTCAE v5.0, gastrointestinal disorders, grade 3 or 4 event.
- 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.
- Currently participating in an interventional clinical trial (observational studies allowed).
- Moribund at time of screening
Key Trial Info
Start Date :
August 26 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 19 2021
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT04488575
Start Date
August 26 2020
End Date
May 19 2021
Last Update
December 19 2022
Active Locations (4)
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1
Robert Wood Johnson University Hospital
New Brunswick, New Jersey, United States, 08901
2
The University Hospital
Newark, New Jersey, United States, 07103
3
DHR Health Institute
Edinburg, Texas, United States, 78539
4
Hacettepe University Adult Hospital
Ankara, Turkey (Türkiye)