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

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

Study Overview

• Status: Terminated
• Conditions: Covid19
• Intervention / Treatment: Drug: Placebo; Drug: EDP1815

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 Type: Interventional
• Enrollment (Actual): 16
• Phase: Phase 2

Contacts and Locations

Study Locations

• Turkey
  • Ankara, Turkey
    • Hacettepe University Adult Hospital
• United States
  • New Jersey
    • New Brunswick, New Jersey, United States, 08901
      • Robert Wood Johnson University Hospital
    • Newark, New Jersey, United States, 07103
      • The University Hospital
  • Texas
    • Edinburg, Texas, United States, 78539
      • DHR Health Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	14 days
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.	14 days
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)	42 days
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)	42 days
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)	42 days
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)	42 days
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).	42 days
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)	42 days
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	42 days
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	42 days
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	42 days
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	42 days
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	42 days
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.	42 days
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.	42 days
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.	42 days
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	42 days
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	42 days
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	42 days

Collaborators and Investigators

• Sponsor: Evelo Biosciences, Inc.
• Investigators: Principal Investigator: Reynold Panettieri, MD, Rutgers, the State University of New Jersey; Study Director: Douglas Maslin, MD, Evelo Biosciences

Study record dates

Study Major Dates

• Study Start (Actual): August 26, 2020
• Primary Completion (Actual): May 16, 2021
• Study Completion (Actual): May 19, 2021

Study Registration Dates

• First Submitted: July 23, 2020
• First Submitted That Met QC Criteria: July 25, 2020
• First Posted (Actual): July 28, 2020

Study Record Updates

• Last Update Posted (Actual): December 19, 2022
• Last Update Submitted That Met QC Criteria: November 22, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: SARS-CoV-2; coronavirus; corona virus; corona
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: EDP1815-205

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No