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

Covid19 Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04488575
• Other study ID #: EDP1815-205
• Status: Terminated
• Phase: Phase 2
• Start date: August 26, 2020
• Est. completion date: May 19, 2021

Study information

• Verified date: July 2022
• Source: Evelo Biosciences, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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)

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 16
• Est. completion date: May 19, 2021
• Est. primary completion date: May 16, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Covid19

Intervention

Drug:
• EDP1815
EDP1815 is an orally administered monoclonal microbe
• Placebo
Placebo oral capsule

Locations

Country	Name	City	State
Turkey	Hacettepe University Adult Hospital	Ankara
United States	DHR Health Institute	Edinburg	Texas
United States	Robert Wood Johnson University Hospital	New Brunswick	New Jersey
United States	The University Hospital	Newark	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Evelo Biosciences, Inc.

Countries where clinical trial is conducted

United States,  Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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