Official Title
A Phase 2 Double-blind Placebo-controlled Study Investigating the Safety and Efficacy of EDP1815 in the Treatment of Patients Hospitalized With SARS-CoV-2 Infection
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 of EDP1815 at reducing time to resolution of
symptoms, preventing progression of COVID-19 symptoms and preventing COVID-Related
Complications (CRC)

Terminated
COVID19

Drug: EDP1815

EDP1815 is an orally administered monoclonal microbe

Drug: Placebo

Placebo oral capsule

Eligibility Criteria

Key Inclusion Criteria:

1. Hospitalized within the last 36 hours.

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

Key Exclusion Criteria:

1. Contraindications/hypersensitivity to P histicola or any of the capsule excipients

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

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: 65 Years
Countries
Turkey
United States
Locations

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

Evelo Biosciences, Inc.
NCT Number
Keywords
SARS-CoV-2
Corona Virus
Coronavirus
Corona
MeSH Terms
COVID-19