Safety and Efficacy of EDP1815 in the Treatment of Patients Hospitalized With COVID-19 Infection
Study Details
Study Description
Brief Summary
Evelo will investigate the safety and efficacy of EDP1815 in the treatment of patients hospitalized with SARS-CoV-2 Infection
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
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
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: EDP1815 Patients will receive EDP1815 in addition to standard of care |
Drug: EDP1815
EDP1815 is an orally administered monoclonal microbe
|
| Placebo Comparator: Placebo Patients will receive placebo in addition to standard of care |
Drug: Placebo
Placebo oral capsule
|
Outcome Measures
Primary Outcome Measures
- Change from baseline to the lowest S/F oxygen ratio [14 days]
Pulmonary function as measured by the change in Oxygen Saturation (SpO2) / Fraction of Inspired Oxygen (FiO2) [S/F ratio]
Secondary Outcome Measures
- Change in S/F Ratio [14 days]
The effect of 1815 on the development and severity of complications of COVID-19 infection will be measured using change in S/F ratio at days 4, 7, 10 and 14/discharge day.
- Percentage change in S/F Ratio [14 days]
The effect of 1815 on the development and severity of complications of COVID-19 infection will be measured using percentage change in S/F ratio at days 4, 7, 10 and 14/discharge day.
- Percentage of participants at each level on the WHO OSCI score [42 days]
The effect of 1815 on the development and severity of complications of COVID-19 infection will be measured using percentage of participants at each level on the WHO OSCI score at days 4, 7, 14, 21 and 42
- Percentage of participants with shifts from each level of the WHO OSCI score at baseline [42 days]
The effect of 1815 on the development and severity of complications of COVID-19 infection will be measured using percentage of participants with shifts from each level of the WHO OSCI score at baseline at days 4, 7, 14, 21 and 42
- Percentage of participants remaining at their baseline score on the WHO OSCI (or lower) [42 days]
The effect of 1815 on the development and severity of complications of COVID-19 infection will be measured using percentage of participants remaining at their baseline score on the WHO OSCI (or lower) at days 4, 7, 14, 21 and 42
- Percentage of participants reporting each level of the WHO OSCI score at their worst post-baseline day [42 days]
The effect of 1815 on the development and severity of complications of COVID-19 infection will be measured using percentage of participants reporting each level of the WHO OSCI score at their worst post-baseline day
- The time in days spent at each participant's worst reported WHO OSCI score (excluding death). [42 days]
The effect of 1815 on the development and severity of complications of COVID-19 infection will be measured using the time in days spent at each participant's worst reported WHO OSCI score (excluding death).
- Intubation and mechanical-ventilation free survival [42 days]
The effect of 1815 on the development and severity of complications of COVID-19 infection will be measured using the intubation and mechanical-ventilation free survival, defined as the time in days from start of treatment to first occurrence of a WHO OSCI score of 6 or more.
- Overall survival [42 days]
The effect of 1815 on the development and severity of complications of COVID-19 infection will be measured using overall survival, defined as the time in days from start of treatment to death by any cause
- Number of days requiring oxygen therapy [42 days]
The effect of 1815 on the development and severity of complications of COVID-19 infection will be measured using number of days requiring oxygen therapy
- Number of days with pyrexia [42 days]
The effect of 1815 on the development and severity of complications of COVID-19 infection will be measured using number of days with pyrexia ≥ 38C
- Maximum daily temperature [42 days]
The effect of 1815 on the development and severity of complications of COVID-19 infection will be measured using maximum daily temperature
- SpO2 level [42 days]
The effect of 1815 on the development and severity of complications of COVID-19 infection will be measured using minimum and maximum SpO2 levels
- Time to discharge [42 days]
The effect of EDP1815 on length of hospitalization and recovery in participants with COVID-19 will be measured using time to discharge, defined as the time in days from start of treatment to first occurrence of a WHO OSCI score of 2 or less.
- Time to oxygen saturation (SpO2) ≥94% [42 days]
The effect of EDP1815 on length of hospitalization and recovery in participants with COVID-19 will be measured using time to oxygen saturation (SpO2) ≥94% on room air without further requirement for oxygen therapy.
- Time to recovery [42 days]
The effect of EDP1815 on length of hospitalization and recovery in participants with COVID-19 will be measured using time to recovery, defined as the time in days from symptom onset to alleviation of all COVID-19 symptoms.
- Number of participants experiencing AEs by seriousness and relationship to treatment [42 days]
The safety and tolerability of EDP1815 in participants with COVID-19 will be measured using the number of participants experiencing AEs by seriousness and relationship to treatment
- Incidence of clinically significant abnormal lab parameters [42 days]
The safety and tolerability of EDP1815 in participants with COVID-19 will be measured using the number of participants experiencing clinically significant abnormal changes in safety lab parameters
Eligibility Criteria
Criteria
Key Inclusion Criteria:
-
Hospitalized within the last 36 hours.
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Receiving any form of supplementary oxygen therapy at baseline.
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Confirmed COVID-19 viral infection by RTPCR at screening.
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Age:
-
18-65 years old, OR
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65 year-olds can be included after DMC approval
Key Exclusion Criteria:
-
Contraindications/hypersensitivity to P histicola or any of the capsule excipients
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Patients with chronic hypoxia or underlying significant chronic respiratory disease (such as COPD, Pulmonary Fibrosis, or Bronchiectasis).
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Admission to ICU at time of screening.
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Mechanically ventilated, on CPAP, or on non-invasive ventilation at the time of screening.
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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.
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Patient has a diagnosed primary immunodeficiency.
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Patient has a diagnosis of HIV/AIDS
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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)
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Patient has pre-existing known significant liver disease with Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 5.0 x upper limit of normal (ULN)
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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.
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GI signs or symptoms equivalent to CTCAE v5.0, gastrointestinal disorders, grade 3 or 4 event.
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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.
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Currently participating in an interventional clinical trial (observational studies allowed).
-
Moribund at time of screening
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Robert Wood Johnson University Hospital | New Brunswick | New Jersey | United States | 08901 |
| 2 | The University Hospital | Newark | New Jersey | United States | 07103 |
Sponsors and Collaborators
- Evelo Biosciences, Inc.
Investigators
- Principal Investigator: Reynold Panettieri, MD, Rutgers, The State University of New Jersey
- Study Director: Douglas Maslin, MD, Evelo Biosciences
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- EDP1815-205