Safety and Efficacy of EDP1815 in the Treatment of Patients Hospitalized With COVID-19 Infection

NCT04488575 | Terminated Phase 2 Results DMC FDA Drug

• 1 other identifier: EDP1815-205
• Study Type: interventional
• Target: 16
• Locations: 2 countries
• Sites: 4

Brief Summary

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

Conditions

Covid19

Keywords

SARS-CoV-2; corona virus; coronavirus; corona

Outcome Measures

Primary Outcomes (1)

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

  Worst pulmonary function as measured by the change in Oxygen Saturation (SpO2) / Fraction of Inspired Oxygen (FiO2) \[S/F ratio\]

  14 days

Secondary Outcomes (19)

• Change in S/F Ratio

  14 days

• Percentage Change in S/F Ratio

  14 days

• Percentage of Participants at Each Level on the WHO OSCI Score

  42 days

• Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline

  42 days

• Number of Participants Remaining at Their Baseline Score on the WHO OSCI (or Lower)

  42 days

Study Arms (2)

EDP1815

EXPERIMENTAL

Patients will receive EDP1815 in addition to standard of care

Drug: EDP1815

Placebo

PLACEBO COMPARATOR

Patients will receive placebo in addition to standard of care

Drug: Placebo

Interventions

EDP1815 DRUG

EDP1815 is an orally administered monoclonal microbe

EDP1815

Placebo DRUG

Placebo oral capsule

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• years old, OR
• \>65 year-olds can be included after Data Monitoring Committee (DMC) approval

You may not qualify if:

• 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

Sponsors & Collaborators

• Evelo Biosciences, Inc.: lead

Study Sites (4)

Robert Wood Johnson University Hospital

New Brunswick, New Jersey, 08901, United States

Location

The University Hospital

Newark, New Jersey, 07103, United States

Location

DHR Health Institute

Edinburg, Texas, 78539, United States

Location

Hacettepe University Adult Hospital

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Conditions

COVID-19; Coronavirus Infections

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Duncan McHale, MBBS, MRCP, PhD
• Organization: Evelo Biosciences Inc

duncan@evelobio.com

+447500128938

Study Officials

• Reynold Panettieri, MD

  Rutgers, The State University of New Jersey

  PRINCIPAL INVESTIGATOR

• Douglas Maslin, MD

  Evelo Biosciences

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Fully blinded to the participants, investigator, and sponsor
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: July 23, 2020
• First Posted: July 28, 2020
• Study Start: August 26, 2020
• Primary Completion: May 16, 2021
• Study Completion: May 19, 2021
• Last Updated: December 19, 2022
• Results First Posted: December 19, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (3); TU (1)