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

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ClinicalTrials.gov Identifier: NCT04488575
Recruitment Status : Recruiting
First Posted : July 28, 2020
Last Update Posted : February 1, 2021
Sponsor:
Information provided by (Responsible Party):
Evelo Biosciences, Inc.

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

Condition or disease Intervention/treatment Phase
Covid19 Drug: EDP1815 Drug: Placebo Phase 2

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)

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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).
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description: Fully blinded to the participants, investigator, and sponsor
Primary Purpose: Treatment
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
Actual Study Start Date : August 26, 2020
Estimated Primary Completion Date : July 6, 2021
Estimated Study Completion Date : July 6, 2021

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




Primary Outcome Measures :
  1. Change from baseline to the lowest S/F oxygen ratio [ Time Frame: 14 days ]
    Pulmonary function as measured by the change in Oxygen Saturation (SpO2) / Fraction of Inspired Oxygen (FiO2) [S/F ratio]


Secondary Outcome Measures :
  1. Change in S/F Ratio [ Time Frame: 14 days ]
    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.

  2. Percentage change in S/F Ratio [ Time Frame: 14 days ]
    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.

  3. Percentage of participants at each level on the WHO OSCI score [ Time Frame: 42 days ]
    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

  4. Percentage of participants with shifts from each level of the WHO OSCI score at baseline [ Time Frame: 42 days ]
    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

  5. Percentage of participants remaining at their baseline score on the WHO OSCI (or lower) [ Time Frame: 42 days ]
    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

  6. Percentage of participants reporting each level of the WHO OSCI score at their worst post-baseline day [ Time Frame: 42 days ]
    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

  7. The time in days spent at each participant's worst reported WHO OSCI score (excluding death). [ Time Frame: 42 days ]
    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).

  8. Intubation and mechanical-ventilation free survival [ Time Frame: 42 days ]
    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.

  9. Overall survival [ Time Frame: 42 days ]
    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

  10. Number of days requiring oxygen therapy [ Time Frame: 42 days ]
    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

  11. Number of days with pyrexia [ Time Frame: 42 days ]
    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

  12. Maximum daily temperature [ Time Frame: 42 days ]
    The effect of 1815 on the development and severity of complications of COVID-19 infection will be measured using maximum daily temperature

  13. SpO2 level [ Time Frame: 42 days ]
    The effect of 1815 on the development and severity of complications of COVID-19 infection will be measured using minimum and maximum SpO2 levels

  14. Time to discharge [ Time Frame: 42 days ]
    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.

  15. Time to oxygen saturation (SpO2) ≥94% [ Time Frame: 42 days ]
    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.

  16. Time to recovery [ Time Frame: 42 days ]
    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.

  17. Number of participants experiencing AEs by seriousness and relationship to treatment [ Time Frame: 42 days ]
    The safety and tolerability of EDP1815 in participants with COVID-19 will be measured using the number of participants experiencing AEs by seriousness and relationship to treatment

  18. Incidence of clinically significant abnormal lab parameters [ Time Frame: 42 days ]
    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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 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 COPD, Pulmonary Fibrosis, or Bronchiectasis).
  3. Admission to ICU at time of screening.
  4. Mechanically ventilated, on 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04488575


Contacts
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Contact: Daniela Walker 6175770300 clinicaltrials@evelobio.com

Locations
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United States, New Jersey
Robert Wood Johnson University Hospital Recruiting
New Brunswick, New Jersey, United States, 08901
Contact: Fei Chen    732-235-5966    chenf2@rwjms.rutgers.edu   
The University Hospital Recruiting
Newark, New Jersey, United States, 07103
Contact: Randall Teeter    973-972-8367    rt502@njms.rutgers.edu   
Sub-Investigator: Sunil Patel, MD         
Sponsors and Collaborators
Evelo Biosciences, Inc.
Investigators
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Principal Investigator: Reynold Panettieri, MD Rutgers, The State University of New Jersey
Study Director: Douglas Maslin, MD Evelo Biosciences
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Responsible Party: Evelo Biosciences, Inc.
ClinicalTrials.gov Identifier: NCT04488575    
Other Study ID Numbers: EDP1815-205
First Posted: July 28, 2020    Key Record Dates
Last Update Posted: February 1, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Evelo Biosciences, Inc.:
SARS-CoV-2
corona virus
coronavirus
corona
Additional relevant MeSH terms:
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COVID-19
Infections
Respiratory Tract Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases