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

Phase 2TerminatedNCT04488575

Evelo Biosciences, Inc.16 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Covid19

Interventions

EDP1815DRUG

EDP1815 is an orally administered monoclonal microbe

PlaceboDRUG

Placebo oral capsule

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (4)

Robert Wood Johnson University Hospital

New Brunswick, New Jersey, United States

The University Hospital

Newark, New Jersey, United States

DHR Health Institute

Edinburg, Texas, United States

Hacettepe University Adult Hospital

Ankara, Turkey (Türkiye)

Outcomes

Primary Outcomes

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) \[S/F ratio\]

Time frame: 14 days

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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)

Time frame: 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)

Time frame: 42 days

Number of Participants Remaining at Their Baseline Score on the WHO OSCI (or Lower)

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

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)

Time frame: 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).

Time frame: 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)

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 42 days