COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04488575

Daniela Walker

dwalker@evelobio.com

2020-07-28

Terminated

RCT

Randomized

Parallel

Blind label

multi-center

Treatment

key inclusion criteria: 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

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

2

Evelo Biosciences, Inc.

18

100

Turkey;United States

Moderate/severe/critical disease at enrollment

5: Moderate/severe/critical disease at enrollment

16

Change From Baseline to the Lowest S/F Oxygen Ratio in Days 1 to 14

None

Phase 2

[{"arm_notes": "", "treatment_id": 445, "treatment_name": "Edp1815", "treatment_type": "Anti-inflammatories", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]