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Anti-Interleukin-8 (Anti-IL-8) for Patients With COVID-19

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ClinicalTrials.gov Identifier: NCT04347226
Recruitment Status : Recruiting
First Posted : April 15, 2020
Last Update Posted : October 8, 2020
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Matthew Dallos, Columbia University

Tracking Information
First Submitted Date  ICMJE April 2, 2020
First Posted Date  ICMJE April 15, 2020
Last Update Posted Date October 8, 2020
Actual Study Start Date  ICMJE April 16, 2020
Estimated Primary Completion Date September 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 29, 2020)
Time to Improvement in the 7-point ordinal scale [ Time Frame: 1 year ]
The time to improvement in the 7-point ordinal scale in patients treated with anti-IL-8 therapy compared to standard of care/controls. Measured from baseline to 2 point or greater improvement in 7-point ordinal scale.
Original Primary Outcome Measures  ICMJE
 (submitted: April 14, 2020)
Time to Improvement in the 7-point ordinal scale [ Time Frame: 1 year ]
To determine the time to improvement in the 7-point ordinal scale in patients treated with anti-IL-8 therapy compared to standard of care/controls. Measured from baseline to 2 point or greater improvement in 7-point ordinal scale.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 29, 2020)
  • Time to Death [ Time Frame: 1 year ]
    The time to death will be defined as the time from onset from symptoms until death from any cause. Patients who are alive or lost to follow-up at the cut-off date will be censored from this analysis.
  • Time to Intubation [ Time Frame: 1 year ]
    The time to intubation will be defined as the time from symptom onset until time of intubation. Any patients already intubated at enrollment will be censored from this analysis.
  • Proportion of patients requiring ICU admission [ Time Frame: 1 year ]
    The proportion of patients requiring intensive care unit (ICU) admission will be calculated as the number of patients requiring ICU admission over the course of their hospitalization over the number of evaluable patients.
  • Percentage Rate of Mortality at 1 month [ Time Frame: 1 month ]
    Percentage of participants who have died 1 month from the time of start of treatment
Original Secondary Outcome Measures  ICMJE
 (submitted: April 14, 2020)
  • Time to Death [ Time Frame: 1 year ]
    The time to death will be defined as the time from onset from symptoms until death from any cause. Patients who are alive or lost to follow-up at the cut-off date will be censored from this analysis.
  • Time to Intubation [ Time Frame: 1 year ]
    The time to intubation will be defined as the time from symptom onset until time of intubation. Any patients already intubated at enrollment will be censored from this analysis.
  • Proportion of patients requiring ICU admission [ Time Frame: 1 year ]
    The proportion of patients requiring intensive care unit (ICU) admission will be calculated as the number of patients requiring ICU admission over the course of their hospitalization over the number of evaluable patients.
  • Mortality at 1 month [ Time Frame: 1 month ]
    Percentage of patients who have died 1 month from the time of start of treatment
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Anti-Interleukin-8 (Anti-IL-8) for Patients With COVID-19
Official Title  ICMJE A Randomized Phase 2 Study of Anti-IL-8 Therapy Versus Standard of Care in the Treatment of Hospitalized Patients With Severe COVID-19
Brief Summary This study is for patients that are hospitalized for Coronavirus Disease 2019 (COVID-19). The purpose of this study is to see whether neutralizing interleukin-8 (IL-8) with BMS-986253 can help improve the health condition of participants infected with COVID-19. This is the first in-human study of this investigational product specifically in patients with severe COVID-19. Currently there are no FDA approved medications that improve the chance of survival in patients diagnosed with COVID-19. However there are usual treatments currently being used to help treat COVID-19 patients and BMS-986253 will be compared to these standard of care treatments in this study.
Detailed Description This is a single center, randomized, open-label, phase 2 trial to evaluate the time-to-improvement in the 7 point ordinal scale following treatment with anti-IL-8 therapy (BMS-986253) compared to standard of care in hospitalized patients with COVID-19 respiratory disease. Patients will be randomized 2:1 to receive either BMS-986253 or standard of care. Patients randomized to treatment with BMS-986253 will receive between 1-3 doses of therapy depending on their clinical status. Participants will be assessed daily while in the hospital and with then be followed for up to 1 year after discharge.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Participants will receive either BMS-986253 2400mg intravenous (IV) at 0 and 2 weeks (if patient is still hospitalized) and then 4 weeks (only if continued severe respiratory disease) or standard of care treatment.
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Solid Tumor
  • Sars-CoV2
  • Hematological Malignancy
Intervention  ICMJE Drug: BMS-986253
BMS-986253 2400mg IV at 0 and 2 weeks (if patient is still hospitalized) and then 4 weeks (only if still hospitalized with continued severe respiratory disease).
Study Arms  ICMJE
  • Experimental: BMS-986253
    BMS-986253 2400mg IV
    Intervention: Drug: BMS-986253
  • No Intervention: Standard of Care treatment
    Usual treatment of COVID-19 per study physician discretion
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 14, 2020)
138
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2022
Estimated Primary Completion Date September 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria

  • Male or female adult ≥ 18 years of age at time of enrollment.
  • Confirmed diagnosis of SARS-CoV-2 infection ≤ 14 days prior to registration.
  • Inpatient hospitalization (or documentation of a plan to admit to the hospital if the patient is in the emergency department)
  • Evidence of pneumonia by chest radiographs, chest CT OR chest auscultation (rales, crackles).
  • Severe respiratory disease (oxygen saturation ≤93% on room air and requiring supplemental oxygen) OR critical respiratory disease (requiring non-rebreather, non-mechanical/mechanical ventilation, high-flow nasal cannula, ICU admission).
  • Patients can continue their anti-cancer therapy at the discretion of the treating physician.
  • Adequate laboratory tests including:

    • absolute neutrophil count (ANC) >500 cells/mm3
    • Platelet count >20,000 cells/mm3
    • Serum total bilirubin <1.5 × upper limit of normal (ULN)
    • alanine aminotransferase (ALT) <5 × ULN
    • aspartate aminotransferase (AST) <5 × ULN
  • Age and Reproductive Status

    1. Males and females, aged at least 18 years old
    2. Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin) within 24 hours prior to the start of study treatment.
    3. Women must not be breastfeeding.
    4. WOCBP must agree to follow instructions for method(s) of contraception for the duration of study treatment plus for a total of 155 days post treatment completion. Local laws and regulations may require use of alternative and/or additional contraception methods.
    5. WOCBP who are continuously not heterosexually active are also exempt from contraceptive requirements, but should still undergo pregnancy testing as described in this section.
    6. Males who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception during study treatment with BMS-986253 for a total of 215 days post-treatment completion.
    7. Azoospermic males are exempt from contraceptive requirements. WOCBP who are continuously not heterosexually active are also exempt from contraceptive requirements, and still must undergo pregnancy testing as described in this section.
  • Willingness to provide written informed consent and HIPAA authorization for the release of personal health information, and the ability to comply with the study requirements (note: HIPAA authorization will be included in the informed consent). In cases of partial impairment, impairment that fluctuates over time, or complete impairment due to dementia, stroke, traumatic brain injury, developmental disorders (including mentally disabled persons), serious mental illness, delirium, medical sedation, or intubation, a subject may be enrolled if the subject's legally authorized representative consents on the subject's behalf.

Exclusion Criteria

  • Treatment with anti-IL-6, anti-IL-6R antagonists or Janus kinase inhibitor (JAKi) within 48 hours of first dose of study treatment.
  • No other investigational therapies with the intent to treat the patient's COVID-19 can be administered while the patient is enrolled in the study.

    o Exception is remdesivir, hydroxychloroquine or other treatments being used as compassionate use for COVID-19.

  • Expected non-COVID-related survival of < 2 months.
  • Ongoing systemic immunosuppressive therapy ≤ 14 days prior to study treatment administration (except for adrenal replacement steroid doses ≤ 10mg daily prednisone equivalent in the absence of active autoimmune disease or a short course of steroids (<5 days) up to 7 days prior to initiating study treatment).
  • Receipt of non-oncology vaccines containing live virus for prevention of infectious diseases within 4 weeks prior to first dose of study treatment
  • History of severe hypersensitivity reaction to any monoclonal antibody (mAb)
  • Multi-organ failure requiring vasopressors or continuous veno-venous hemofiltration (CVVH) or extracorporeal membrane oxygenation.
  • No active systemic bacterial or fungal infection o Patients with a history of positive bacterial or fungal cultures but on enrollment do not have suspected or known active systemic bacterial or fungal infections are permitted.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Research Nurse Navigator 212.342.5162 cancerclinicaltrials@cumc.columbia.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04347226
Other Study ID Numbers  ICMJE AAAS9881
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Matthew Dallos, Columbia University
Study Sponsor  ICMJE Matthew Dallos
Collaborators  ICMJE Bristol-Myers Squibb
Investigators  ICMJE
Principal Investigator: Matthew Dallos, MD Columbia University
PRS Account Columbia University
Verification Date October 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP