Back to resultsSafety and Efficacy of EDP1815 in the Treatment of Patients Hospitalized With COVID-19 Infection
Primary Purpose
Covid19
Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
EDP1815
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Covid19 focused on measuring SARS-CoV-2, corona virus, coronavirus, corona
Eligibility Criteria
Key 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.
Age:
- 18-65 years old, OR
- >65 year-olds can be included after Data Monitoring Committee (DMC) approval
Key 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
Sites / Locations
- Robert Wood Johnson University Hospital
- The University Hospital
- DHR Health Institute
- Hacettepe University Adult Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
EDP1815
Placebo
Arm Description
Patients will receive EDP1815 in addition to standard of care
Patients will receive placebo in addition to standard of care
Outcomes
Primary Outcome Measures
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]
Secondary Outcome Measures
Change in S/F Ratio
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
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
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.
(WHO OSCI - World health Organization, Ordinal Scale for Clinical Improvement; 0=unifected - 8=death)
Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline
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.
(WHO OSCI - World health Organization, Ordinal Scale for Clinical Improvement; 0=uninfected - 8=death)
Number of Participants Remaining at Their Baseline Score on the WHO OSCI (or Lower)
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. Once a participant has increased their WHO OSCI score they are not considered to have remained at or below their baseline value at future visits regardless of whether their score returns to or below their baseline value.
(WHO OSCI - World health Organization, Ordinal Scale for Clinical Improvement; 0=uninfected - 8=death)
Percentage of Participants Reporting Each Level of the WHO OSCI Score at Their Worst Post-baseline Day
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.
(WHO OSCI - World health Organization, Ordinal Scale for Clinical Improvement; 0=uninfected - 8=death)
The Time in Days Spent at Each Participant's Worst Reported WHO OSCI Score (Excluding Death).
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
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.
(WHO OSCI - World health Organization, Ordinal Scale for Clinical Improvement; 0=uninfected - 8=death)
Overall Survival
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
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
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
The effect of 1815 on the development and severity of complications of COVID-19 infection will be measured using maximum daily temperature
SpO2 Level
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
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%
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
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
The safety and tolerability of EDP1815 in participants with COVID-19 will be measured using the number of participants experiencing AEs by relationship to treatment
Incidence of Clinically Significant Abnormal Lab Parameters
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
Number of Participants Experiencing AEs by Seriousness and Relationship to Treatment
The safety and tolerability of EDP1815 in participants with COVID-19 will be measured using the number of participants experiencing AEs by seriousness
Full Information
NCT ID
NCT04488575
First Posted
July 23, 2020
Last Updated
November 22, 2022
Sponsor
Evelo Biosciences, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT04488575
Brief Title
Safety and Efficacy of EDP1815 in the Treatment of Patients Hospitalized With COVID-19 Infection
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Terminated
Why Stopped
Insufficient study defined patient population
Study Start Date
August 26, 2020 (Actual)
Primary Completion Date
May 16, 2021 (Actual)
Study Completion Date
May 19, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Evelo Biosciences, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19
Keywords
SARS-CoV-2, corona virus, coronavirus, corona
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
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
ParticipantInvestigatorOutcomes Assessor
Masking Description
Fully blinded to the participants, investigator, and sponsor
Allocation
Randomized
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
EDP1815
Arm Type
Experimental
Arm Description
Patients will receive EDP1815 in addition to standard of care
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Patients will receive placebo in addition to standard of care
Intervention Type
Drug
Intervention Name(s)
EDP1815
Intervention Description
EDP1815 is an orally administered monoclonal microbe
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo oral capsule
Primary Outcome Measure Information:
Title
Change From Baseline to the Lowest S/F Oxygen Ratio in Days 1 to 14
Description
Worst pulmonary function as measured by the change in Oxygen Saturation (SpO2) / Fraction of Inspired Oxygen (FiO2) [S/F ratio]
Time Frame
14 days
Secondary Outcome Measure Information:
Title
Change in S/F Ratio
Description
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.
Time Frame
14 days
Title
Percentage Change in S/F Ratio
Description
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.
Time Frame
14 days
Title
Percentage of Participants at Each Level on the WHO OSCI Score
Description
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.
(WHO OSCI - World health Organization, Ordinal Scale for Clinical Improvement; 0=unifected - 8=death)
Time Frame
42 days
Title
Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline
Description
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.
(WHO OSCI - World health Organization, Ordinal Scale for Clinical Improvement; 0=uninfected - 8=death)
Time Frame
42 days
Title
Number of Participants Remaining at Their Baseline Score on the WHO OSCI (or Lower)
Description
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. Once a participant has increased their WHO OSCI score they are not considered to have remained at or below their baseline value at future visits regardless of whether their score returns to or below their baseline value.
(WHO OSCI - World health Organization, Ordinal Scale for Clinical Improvement; 0=uninfected - 8=death)
Time Frame
42 days
Title
Percentage of Participants Reporting Each Level of the WHO OSCI Score at Their Worst Post-baseline Day
Description
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.
(WHO OSCI - World health Organization, Ordinal Scale for Clinical Improvement; 0=uninfected - 8=death)
Time Frame
42 days
Title
The Time in Days Spent at Each Participant's Worst Reported WHO OSCI Score (Excluding Death).
Description
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).
Time Frame
42 days
Title
Intubation and Mechanical-ventilation Free Survival
Description
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.
(WHO OSCI - World health Organization, Ordinal Scale for Clinical Improvement; 0=uninfected - 8=death)
Time Frame
42 days
Title
Overall Survival
Description
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
Time Frame
42 days
Title
Number of Days Requiring Oxygen Therapy
Description
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
Time Frame
42 days
Title
Number of Days With Pyrexia
Description
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
Time Frame
42 days
Title
Maximum Daily Temperature
Description
The effect of 1815 on the development and severity of complications of COVID-19 infection will be measured using maximum daily temperature
Time Frame
42 days
Title
SpO2 Level
Description
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 Frame
42 days
Title
Time to Discharge
Description
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 Frame
42 days
Title
Time to Oxygen Saturation (SpO2) ≥94%
Description
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 Frame
42 days
Title
Time to Recovery
Description
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.
Time Frame
42 days
Title
Number of Participants Experiencing AEs by Seriousness and Relationship to Treatment
Description
The safety and tolerability of EDP1815 in participants with COVID-19 will be measured using the number of participants experiencing AEs by relationship to treatment
Time Frame
42 days
Title
Incidence of Clinically Significant Abnormal Lab Parameters
Description
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
Time Frame
42 days
Title
Number of Participants Experiencing AEs by Seriousness and Relationship to Treatment
Description
The safety and tolerability of EDP1815 in participants with COVID-19 will be measured using the number of participants experiencing AEs by seriousness
Time Frame
42 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key 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.
Age:
18-65 years old, OR
>65 year-olds can be included after Data Monitoring Committee (DMC) approval
Key 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Reynold Panettieri, MD
Organizational Affiliation
Rutgers, The State University of New Jersey
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Douglas Maslin, MD
Organizational Affiliation
Evelo Biosciences
Official's Role
Study Director
Facility Information:
Facility Name
Robert Wood Johnson University Hospital
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901
Country
United States
Facility Name
The University Hospital
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07103
Country
United States
Facility Name
DHR Health Institute
City
Edinburg
State/Province
Texas
ZIP/Postal Code
78539
Country
United States
Facility Name
Hacettepe University Adult Hospital
City
Ankara
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Safety and Efficacy of EDP1815 in the Treatment of Patients Hospitalized With COVID-19 Infection
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