Clinical trial NCT04488575: 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
Overall status: TERMINATED
Phase: PHASE2
Conditions: Covid19
Keywords: SARS-CoV-2
corona virus
coronavirus
corona
Lead sponsor: Evelo Biosciences, Inc.
Sponsor class: INDUSTRY
First posted: 2020-07-28
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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).
Primary purpose: TREATMENT

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)

Eligibility criteria: 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

Primary outcomes:
measure: Change From Baseline to the Lowest S/F Oxygen Ratio in Days 1 to 14
timeFrame: 14 days
Secondary outcomes:
measure: Change in S/F Ratio
timeFrame: 14 days
measure: Percentage Change in S/F Ratio
timeFrame: 14 days
measure: Percentage of Participants at Each Level on the WHO OSCI Score
timeFrame: 42 days
measure: Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline
timeFrame: 42 days
measure: Number of Participants Remaining at Their Baseline Score on the WHO OSCI (or Lower)
timeFrame: 42 days
measure: Percentage of Participants Reporting Each Level of the WHO OSCI Score at Their Worst Post-baseline Day
timeFrame: 42 days
measure: The Time in Days Spent at Each Participant's Worst Reported WHO OSCI Score (Excluding Death).
timeFrame: 42 days
measure: Intubation and Mechanical-ventilation Free Survival
timeFrame: 42 days
measure: Overall Survival
timeFrame: 42 days
measure: Number of Days Requiring Oxygen Therapy
timeFrame: 42 days
measure: Number of Days With Pyrexia
timeFrame: 42 days
measure: Maximum Daily Temperature
timeFrame: 42 days
measure: SpO2 Level
timeFrame: 42 days
measure: Time to Discharge
timeFrame: 42 days
measure: Time to Oxygen Saturation (SpO2) ≥94%
timeFrame: 42 days
measure: Time to Recovery
timeFrame: 42 days
measure: Number of Participants Experiencing AEs by Seriousness and Relationship to Treatment
timeFrame: 42 days
measure: Incidence of Clinically Significant Abnormal Lab Parameters
timeFrame: 42 days
measure: Number of Participants Experiencing AEs by Seriousness and Relationship to Treatment
timeFrame: 42 days
Other outcomes:
Locations:
city: New Brunswick
country: United States
facility: Robert Wood Johnson University Hospital
state: New Jersey
city: Newark
country: United States
facility: The University Hospital
state: New Jersey
city: Edinburg
country: United States
facility: DHR Health Institute
state: Texas
city: Ankara
country: Turkey
facility: Hacettepe University Adult Hospital
Study officials:
affiliation: Rutgers, The State University of New Jersey
name: Reynold Panettieri, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Evelo Biosciences
name: Douglas Maslin, MD
role: STUDY_DIRECTOR
References: