Safety and Efficacy of EDP1815 in the Treatment of Patients Hospitalized With COVID-19 Infection
Condition: Covid19
MeSH terms: COVID-19
Intervention: EDP1815; Placebo
Intervention description: EDP1815 is an orally administered monoclonal microbe; Placebo oral capsule
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Patients will be randomized to either the active (EDP1815) or placebo group (1:1 randomization), in addition to standard of care. Dosing will be initiated on a twice daily regime for the first 3 days (6 doses) and then once daily for the remaining 11 days (14 days total treatment course).
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking description: Fully blinded to the participants, investigator, and sponsor
Enrollment: 16.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: SARS-CoV-2; corona virus; coronavirus; corona

Summary:

      Evelo will investigate the safety and efficacy of EDP1815 in the treatment of patients
      hospitalized with SARS-CoV-2 Infection
    

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