NCT04488575TerminatedPhase 2
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
Evelo Biosciences, Inc.4 sites in 2 countries16 target enrollmentStarted: August 26, 2020Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 2
- Status
- Terminated
- Sponsor
- Evelo Biosciences, Inc.
- Enrollment
- 16
- Locations
- 4
- Primary Endpoint
- Change From Baseline to the Lowest S/F Oxygen Ratio in Days 1 to 14
Study Overview
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)
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Masking Description
Fully blinded to the participants, investigator, and sponsor
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
- •18-65 years old, OR
- •>65 year-olds can be included after Data Monitoring Committee (DMC) approval
Exclusion Criteria
- •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
Arms & Interventions
EDP1815
Experimental
Patients will receive EDP1815 in addition to standard of care
Intervention: EDP1815 (Drug)
Placebo
Placebo Comparator
Patients will receive placebo in addition to standard of care
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Change From Baseline to the Lowest S/F Oxygen Ratio in Days 1 to 14
Time Frame: 14 days
Worst pulmonary function as measured by the change in Oxygen Saturation (SpO2) / Fraction of Inspired Oxygen (FiO2) \[S/F ratio\]
Secondary Outcomes
- Intubation and Mechanical-ventilation Free Survival(42 days)
- Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline(42 days)
- Incidence of Clinically Significant Abnormal Lab Parameters(42 days)
- Percentage Change in S/F Ratio(14 days)
- Overall Survival(42 days)
- Change in S/F Ratio(14 days)
- Percentage of Participants at Each Level on the WHO OSCI Score(42 days)
- Number of Participants Remaining at Their Baseline Score on the WHO OSCI (or Lower)(42 days)
- Percentage of Participants Reporting Each Level of the WHO OSCI Score at Their Worst Post-baseline Day(42 days)
- The Time in Days Spent at Each Participant's Worst Reported WHO OSCI Score (Excluding Death).(42 days)
- Number of Days Requiring Oxygen Therapy(42 days)
- Number of Days With Pyrexia(42 days)
- Maximum Daily Temperature(42 days)
- SpO2 Level(42 days)
- Time to Discharge(42 days)
- Time to Oxygen Saturation (SpO2) ≥94%(42 days)
- Time to Recovery(42 days)
- Number of Participants Experiencing AEs by Seriousness and Relationship to Treatment(42 days)
Investigators
Study Sites (4)
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