Study for the Use of the IL-6 Inhibitor Clazakizumab in Patients With Life-threatening COVID-19 Infection

Sponsor
Columbia University (Other)
Overall Status
Terminated
CT.gov ID
NCT04381052
Collaborator
NYU Langone Health (Other), CSL Behring (Industry)
1
1
2
10.4
0.1

Study Details

Study Description

Brief Summary

In this study, the investigators propose to administer clazakizumab to patients with life-threatening Coronavirus Disease 2019 (COVID-19) infection manifest by pulmonary failure and a clinical picture consistent with a cytokine storm syndrome. This is a single-center randomized, double-blind, placebo-controlled trial in which 30 patients will be enrolled and randomly assigned in a 1:1 ratio to two study arms and receive clazakizumab at a dose of 25 mg or placebo.

Condition or Disease Intervention/Treatment Phase
Phase 2

Detailed Description

The limited understanding of the clinical behavior of patients infected with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (the viral organism responsible for COVID-19 disease) is evolving on a daily basis. Reports from China indicate that a subset of patients with the worst clinical outcomes may manifest cytokine storm syndrome. Hypotheses that excess cytokines may trigger a secondary hemophagocytic lymphohistiocytosis (sHLH) have been proposed. Indeed, cytokine profiles consistent with this picture were observed in Chinese patients with severe pulmonary involvement. Specifically, elevated ferritin and interleukin-6 (IL-6) were associated with fatalities among the infected patients. A role for targeted anti-inflammatory and anti-cytokine therapies in the treatment of pulmonary hyperinflammation has been proposed.

Clazakizumab is a genetically engineered humanized immunoglobulin-1 (IgG1) monoclonal antibody (mAb) that binds with high affinity to human IL-6. This investigational agent is currently being studied as a treatment for chronic active antibody mediated rejection of renal allografts.

In this study investigators propose to administer clazakizumab to patients with life-threatening pulmonary failure secondary to COVID-19 disease.

Study Design

Study Type:
Interventional
Actual Enrollment :
1 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
This is a randomized, double-blind, placebo-controlled, adaptive seamless Phase II/III design (ASD). The investigators propose the administration of an investigational drug in patients with high predicted short-term mortality secondary to COVID-19 disease. Patients will be enrolled and randomly assigned in a 1:1 ratio to two study arms that will receive clazakizumab at a dose of 25 mg or placebo.This is a randomized, double-blind, placebo-controlled, adaptive seamless Phase II/III design (ASD). The investigators propose the administration of an investigational drug in patients with high predicted short-term mortality secondary to COVID-19 disease. Patients will be enrolled and randomly assigned in a 1:1 ratio to two study arms that will receive clazakizumab at a dose of 25 mg or placebo.
Masking:
Double (Participant, Investigator)
Masking Description:
This study is double-blind and therefore neither the Investigator, the subject, the Sponsor and its representatives, nor other designated study site personnel involved in running of the study will be aware of the identification of the investigational drug administered to each subject.
Primary Purpose:
Treatment
Official Title:
A Randomized Placebo-Controlled Safety and Dose-Finding Study for the Use of the IL-6 Inhibitor Clazakizumab in Patients With Life-threatening COVID-19 Infection
Actual Study Start Date :
May 18, 2020
Actual Primary Completion Date :
Apr 1, 2021
Actual Study Completion Date :
Apr 1, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Clazakizumab 25 mg

The first dose will be administered as soon as possible after the patient is enrolled and randomized into the Clazakizumab 25 mg arm. The route of administration will be intravenous. Each dose will be administered as an infusion that is run over 30 minutes. Serum C-reactive protein (CRP) will be evaluated at baseline and on days 1 and 2 following clazakizumab administration. If the CRP does not decrease by 50% within 36-48 hours after the first dose, a second dose of 25 mg clazakizumab will be given no later than day 3.

Drug: Clazakizumab
Dose is 25mg intravenously over 30 minutes.
Other Names:
  • Clazakizumab solution
  • Placebo Comparator: Placebo

    The first dose will be administered as soon as possible after the patient is enrolled and randomized into the Placebo arm. The route of administration will be intravenous. Each dose will be administered as an infusion that is run over 30 minutes. Serum CRP will be evaluated at baseline and on days 1 and 2 following clazakizumab administration. If the CRP does not decrease by 50% within 36-48 hours after the first dose, a second dose of placebo will be given no later than day 3.

    Other: Placebo
    Intravenously administered over 30 minutes.

    Outcome Measures

    Primary Outcome Measures

    1. Cumulative Incidence of Serious Adverse Events Associated With Clazakizumab or Placebo [60 days]

    Secondary Outcome Measures

    1. Cumulative Incidence of Intubation [14 days]

    2. Time to Extubation [14 days]

    3. Length of Intensive Care Unit (ICU) Stay [14 days]

    4. Number of Patients Who Present a Decrease in C-reactive Protein (CRP) [14 days]

    5. Number of Patients With Acute Kidney Injury (AKI) [14 days]

    6. Number of Patients With a Need for Renal Replacement Therapy (RRT) [14 days]

    7. Duration of Renal Replacement Therapy (RRT) [60 days]

    8. Patient Survival [28 days]

      Number of participants alive at day 28.

    9. Patient Survival [60 days]

      Number of participants alive at day 60, end of study.

    10. Number of Patients With Hemodialysis [60 days]

    11. Number of Patients With Continuous Renal Replacement Therapies (CRRT) [60 days]

    12. Number of Patients With Peritoneal Dialysis [60 days]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    In order to be eligible to participate in this study, the patients must meet all of the following criteria:

    1. At least 18 years of age

    2. Confirmed COVID-19 disease (by Cobas SARS-CoV-2 real time reverse transcription polymerase chain reaction (RT-PCR) using nasopharyngeal swab sample, or equivalent test available to be performed by the Columbia University Irving Medical Center (CUIMC)/New York Presbyterian (NYP) clinical laboratory). Effort will be made to have the confirmatory test result <72 hours prior to enrollment however given overall clinical demand this may not be feasible in all cases.

    3. Respiratory failure manifesting as: Acute Respiratory Distress Syndrome (defined by a P/F ratio of <200), OR oxygen saturation (SpO2) < 90% on 4 liters (L) (actual or expected given higher O2 requirement) OR increasing O2 requirements over 24 hours, plus 2 or more of the following predictors for severe disease:

    CRP > 35 mg/L Ferritin > 500 ng/mL D-dimer > 1 mcg/L Neutrophil-Lymphocyte Ratio > 4 Lactate dehydrogenase (LDH) > 200 U/L Increase in troponin in patient w/out known cardiac disease

    1. Has a consent designee willing to provide informed consent on behalf of the patient (this assumes that a mechanically ventilated patients lacks capacity to consent on his/her own behalf. Should it be deemed that the patient has capacity to consent, consent may be obtained from the patient.)

    2. Women of childbearing potential must be willing and able to use at least one highly effective contraceptive method for a period of 5 months following the study drug administration. In the context of this study, an effective method is defined as those which result in low failure rate (i.e. less than 1% per year) when used consistently and correctly such as:

    3. combined (estrogen and progestogen containing) hormonal contraception combined (estrogen and progestogen containing) hormonal contraception (oral, intravaginal, or transdermal)

    4. progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable)

    5. intrauterine device (IUD)

    6. intrauterine hormone-releasing system (IUS)

    7. vasectomized partner

    8. bilateral tubal occlusion

    9. true abstinence. when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence, such as calendar, ovulation, symptothermal, postovulation methods, and withdrawal are not acceptable methods of contraception.

    10. Men must be willing to use a double-barrier contraception from enrollment until at 5 months after the last dose of study drug, if not abstinent.

    Exclusion Criteria:

    An individual who meets any of the following criteria will be excluded from participation in this study:

    1. Evidence of irreversible injury deemed non-survivable even if the pulmonary failure recovers (for example severe anoxic brain injury)

    2. Known active inflammatory bowel disease

    3. Known active, untreated diverticulitis

    4. Known untreated bacteremia

    5. Pregnancy. (The protocol will exclude pregnant subjects given the lack of overall data on use of clazakizumab in pregnancy however the study team would consider a protocol revision should more than 3 potential pregnant study subjects be excluded on this basis).

    6. Known hypersensitivity to the clazakizumab

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Columbia University Medical Center / New York Presbyerian Hospital New York New York United States 10032

    Sponsors and Collaborators

    • Columbia University
    • NYU Langone Health
    • CSL Behring

    Investigators

    • Principal Investigator: David J. Cohen, MD, Columbia University

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    Columbia University
    ClinicalTrials.gov Identifier:
    NCT04381052
    Other Study ID Numbers:
    • AAAT0142
    First Posted:
    May 8, 2020
    Last Update Posted:
    Apr 8, 2022
    Last Verified:
    Apr 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Columbia University
    Additional relevant MeSH terms:

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail Study was closed due to no further development. Data was not analyzed or disclosed due to subject confidentiality being an issue (n=1). Assignment was not unblinded/disclosed.
    Arm/Group Title Clazakizumab 25 mg or Placebo
    Arm/Group Description The first dose will be administered as soon as possible after the patient is enrolled and randomized into a specific arm. The route of administration will be intravenous. Each dose will be administered as an infusion that is run over 30 minutes. Serum CRP will be evaluated at baseline and on days 1 and 2 following first dose administration. If the CRP does not decrease by 50% within 36-48 hours after the first dose, a second dose of placebo will be given no later than day 3. Placebo: Intravenously administered over 30 minutes. OR Clazakizumab: Dose is 25mg intravenously over 30 minutes.
    Period Title: Overall Study
    STARTED 1
    COMPLETED 1
    NOT COMPLETED 0

    Baseline Characteristics

    Arm/Group Title Clazakizumab 25 mg Placebo Total
    Arm/Group Description The first dose will be administered as soon as possible after the patient is enrolled and randomized into the Clazakizumab 25 mg arm. The route of administration will be intravenous. Each dose will be administered as an infusion that is run over 30 minutes. Serum C-reactive protein (CRP) will be evaluated at baseline and on days 1 and 2 following clazakizumab administration. If the CRP does not decrease by 50% within 36-48 hours after the first dose, a second dose of 25 mg clazakizumab will be given no later than day 3. Clazakizumab: Dose is 25mg intravenously over 30 minutes. The first dose will be administered as soon as possible after the patient is enrolled and randomized into the Placebo arm. The route of administration will be intravenous. Each dose will be administered as an infusion that is run over 30 minutes. Serum CRP will be evaluated at baseline and on days 1 and 2 following clazakizumab administration. If the CRP does not decrease by 50% within 36-48 hours after the first dose, a second dose of placebo will be given no later than day 3. Placebo: Intravenously administered over 30 minutes. Total of all reporting groups
    Overall Participants 0 0 0
    Age () []
    <=18 years
    Between 18 and 65 years
    >=65 years
    Sex: Female, Male () []
    Female
    Male
    Ethnicity (NIH/OMB) () []
    Hispanic or Latino
    Not Hispanic or Latino
    Unknown or Not Reported
    Race (NIH/OMB) () []
    American Indian or Alaska Native
    Asian
    Native Hawaiian or Other Pacific Islander
    Black or African American
    White
    More than one race
    Unknown or Not Reported
    Region of Enrollment (participants) []

    Outcome Measures

    1. Primary Outcome
    Title Cumulative Incidence of Serious Adverse Events Associated With Clazakizumab or Placebo
    Description
    Time Frame 60 days

    Outcome Measure Data

    Analysis Population Description
    Study stopped due to no further development. Data was not analyzed or disclosed due to subject confidentiality being an issue (n=1). Assignment was not unblinded/disclosed.
    Arm/Group Title Clazakizumab 25 mg Placebo
    Arm/Group Description The first dose will be administered as soon as possible after the patient is enrolled and randomized into the Clazakizumab 25 mg arm. The route of administration will be intravenous. Each dose will be administered as an infusion that is run over 30 minutes. Serum C-reactive protein (CRP) will be evaluated at baseline and on days 1 and 2 following clazakizumab administration. If the CRP does not decrease by 50% within 36-48 hours after the first dose, a second dose of 25 mg clazakizumab will be given no later than day 3. Clazakizumab: Dose is 25mg intravenously over 30 minutes. The first dose will be administered as soon as possible after the patient is enrolled and randomized into the Placebo arm. The route of administration will be intravenous. Each dose will be administered as an infusion that is run over 30 minutes. Serum CRP will be evaluated at baseline and on days 1 and 2 following clazakizumab administration. If the CRP does not decrease by 50% within 36-48 hours after the first dose, a second dose of placebo will be given no later than day 3. Placebo: Intravenously administered over 30 minutes.
    Measure Participants 0 0
    2. Secondary Outcome
    Title Cumulative Incidence of Intubation
    Description
    Time Frame 14 days

    Outcome Measure Data

    Analysis Population Description
    Study stopped due to no further development. Data was not analyzed or disclosed due to subject confidentiality being an issue (n=1). Assignment was not unblinded/disclosed.
    Arm/Group Title Clazakizumab 25 mg Placebo
    Arm/Group Description The first dose will be administered as soon as possible after the patient is enrolled and randomized into the Clazakizumab 25 mg arm. The route of administration will be intravenous. Each dose will be administered as an infusion that is run over 30 minutes. Serum C-reactive protein (CRP) will be evaluated at baseline and on days 1 and 2 following clazakizumab administration. If the CRP does not decrease by 50% within 36-48 hours after the first dose, a second dose of 25 mg clazakizumab will be given no later than day 3. Clazakizumab: Dose is 25mg intravenously over 30 minutes. The first dose will be administered as soon as possible after the patient is enrolled and randomized into the Placebo arm. The route of administration will be intravenous. Each dose will be administered as an infusion that is run over 30 minutes. Serum CRP will be evaluated at baseline and on days 1 and 2 following clazakizumab administration. If the CRP does not decrease by 50% within 36-48 hours after the first dose, a second dose of placebo will be given no later than day 3. Placebo: Intravenously administered over 30 minutes.
    Measure Participants 0 0
    3. Secondary Outcome
    Title Time to Extubation
    Description
    Time Frame 14 days

    Outcome Measure Data

    Analysis Population Description
    Study stopped due to no further development. Data was not analyzed or disclosed due to subject confidentiality being an issue (n=1). Assignment was not unblinded/disclosed.
    Arm/Group Title Clazakizumab 25 mg Placebo
    Arm/Group Description The first dose will be administered as soon as possible after the patient is enrolled and randomized into the Clazakizumab 25 mg arm. The route of administration will be intravenous. Each dose will be administered as an infusion that is run over 30 minutes. Serum C-reactive protein (CRP) will be evaluated at baseline and on days 1 and 2 following clazakizumab administration. If the CRP does not decrease by 50% within 36-48 hours after the first dose, a second dose of 25 mg clazakizumab will be given no later than day 3. Clazakizumab: Dose is 25mg intravenously over 30 minutes. The first dose will be administered as soon as possible after the patient is enrolled and randomized into the Placebo arm. The route of administration will be intravenous. Each dose will be administered as an infusion that is run over 30 minutes. Serum CRP will be evaluated at baseline and on days 1 and 2 following clazakizumab administration. If the CRP does not decrease by 50% within 36-48 hours after the first dose, a second dose of placebo will be given no later than day 3. Placebo: Intravenously administered over 30 minutes.
    Measure Participants 0 0
    4. Secondary Outcome
    Title Length of Intensive Care Unit (ICU) Stay
    Description
    Time Frame 14 days

    Outcome Measure Data

    Analysis Population Description
    Study stopped due to no further development. Data was not analyzed or disclosed due to subject confidentiality being an issue (n=1). Assignment was not unblinded/disclosed.
    Arm/Group Title Clazakizumab 25 mg Placebo
    Arm/Group Description The first dose will be administered as soon as possible after the patient is enrolled and randomized into the Clazakizumab 25 mg arm. The route of administration will be intravenous. Each dose will be administered as an infusion that is run over 30 minutes. Serum C-reactive protein (CRP) will be evaluated at baseline and on days 1 and 2 following clazakizumab administration. If the CRP does not decrease by 50% within 36-48 hours after the first dose, a second dose of 25 mg clazakizumab will be given no later than day 3. Clazakizumab: Dose is 25mg intravenously over 30 minutes. The first dose will be administered as soon as possible after the patient is enrolled and randomized into the Placebo arm. The route of administration will be intravenous. Each dose will be administered as an infusion that is run over 30 minutes. Serum CRP will be evaluated at baseline and on days 1 and 2 following clazakizumab administration. If the CRP does not decrease by 50% within 36-48 hours after the first dose, a second dose of placebo will be given no later than day 3. Placebo: Intravenously administered over 30 minutes.
    Measure Participants 0 0
    5. Secondary Outcome
    Title Number of Patients Who Present a Decrease in C-reactive Protein (CRP)
    Description
    Time Frame 14 days

    Outcome Measure Data

    Analysis Population Description
    Study stopped due to no further development. Data was not analyzed or disclosed due to subject confidentiality being an issue (n=1). Assignment was not unblinded/disclosed.
    Arm/Group Title Clazakizumab 25 mg Placebo
    Arm/Group Description The first dose will be administered as soon as possible after the patient is enrolled and randomized into the Clazakizumab 25 mg arm. The route of administration will be intravenous. Each dose will be administered as an infusion that is run over 30 minutes. Serum C-reactive protein (CRP) will be evaluated at baseline and on days 1 and 2 following clazakizumab administration. If the CRP does not decrease by 50% within 36-48 hours after the first dose, a second dose of 25 mg clazakizumab will be given no later than day 3. Clazakizumab: Dose is 25mg intravenously over 30 minutes. The first dose will be administered as soon as possible after the patient is enrolled and randomized into the Placebo arm. The route of administration will be intravenous. Each dose will be administered as an infusion that is run over 30 minutes. Serum CRP will be evaluated at baseline and on days 1 and 2 following clazakizumab administration. If the CRP does not decrease by 50% within 36-48 hours after the first dose, a second dose of placebo will be given no later than day 3. Placebo: Intravenously administered over 30 minutes.
    Measure Participants 0 0
    6. Secondary Outcome
    Title Number of Patients With Acute Kidney Injury (AKI)
    Description
    Time Frame 14 days

    Outcome Measure Data

    Analysis Population Description
    Study stopped due to no further development. Data was not analyzed or disclosed due to subject confidentiality being an issue (n=1). Assignment was not unblinded/disclosed.
    Arm/Group Title Clazakizumab 25 mg Placebo
    Arm/Group Description The first dose will be administered as soon as possible after the patient is enrolled and randomized into the Clazakizumab 25 mg arm. The route of administration will be intravenous. Each dose will be administered as an infusion that is run over 30 minutes. Serum C-reactive protein (CRP) will be evaluated at baseline and on days 1 and 2 following clazakizumab administration. If the CRP does not decrease by 50% within 36-48 hours after the first dose, a second dose of 25 mg clazakizumab will be given no later than day 3. Clazakizumab: Dose is 25mg intravenously over 30 minutes. The first dose will be administered as soon as possible after the patient is enrolled and randomized into the Placebo arm. The route of administration will be intravenous. Each dose will be administered as an infusion that is run over 30 minutes. Serum CRP will be evaluated at baseline and on days 1 and 2 following clazakizumab administration. If the CRP does not decrease by 50% within 36-48 hours after the first dose, a second dose of placebo will be given no later than day 3. Placebo: Intravenously administered over 30 minutes.
    Measure Participants 0 0
    7. Secondary Outcome
    Title Number of Patients With a Need for Renal Replacement Therapy (RRT)
    Description
    Time Frame 14 days

    Outcome Measure Data

    Analysis Population Description
    Study stopped due to no further development. Data was not analyzed or disclosed due to subject confidentiality being an issue (n=1). Assignment was not unblinded/disclosed.
    Arm/Group Title Clazakizumab 25 mg Placebo
    Arm/Group Description The first dose will be administered as soon as possible after the patient is enrolled and randomized into the Clazakizumab 25 mg arm. The route of administration will be intravenous. Each dose will be administered as an infusion that is run over 30 minutes. Serum C-reactive protein (CRP) will be evaluated at baseline and on days 1 and 2 following clazakizumab administration. If the CRP does not decrease by 50% within 36-48 hours after the first dose, a second dose of 25 mg clazakizumab will be given no later than day 3. Clazakizumab: Dose is 25mg intravenously over 30 minutes. The first dose will be administered as soon as possible after the patient is enrolled and randomized into the Placebo arm. The route of administration will be intravenous. Each dose will be administered as an infusion that is run over 30 minutes. Serum CRP will be evaluated at baseline and on days 1 and 2 following clazakizumab administration. If the CRP does not decrease by 50% within 36-48 hours after the first dose, a second dose of placebo will be given no later than day 3. Placebo: Intravenously administered over 30 minutes.
    Measure Participants 0 0
    8. Secondary Outcome
    Title Duration of Renal Replacement Therapy (RRT)
    Description
    Time Frame 60 days

    Outcome Measure Data

    Analysis Population Description
    Study stopped due to no further development. Data was not analyzed or disclosed due to subject confidentiality being an issue (n=1). Assignment was not unblinded/disclosed.
    Arm/Group Title Clazakizumab 25 mg Placebo
    Arm/Group Description The first dose will be administered as soon as possible after the patient is enrolled and randomized into the Clazakizumab 25 mg arm. The route of administration will be intravenous. Each dose will be administered as an infusion that is run over 30 minutes. Serum C-reactive protein (CRP) will be evaluated at baseline and on days 1 and 2 following clazakizumab administration. If the CRP does not decrease by 50% within 36-48 hours after the first dose, a second dose of 25 mg clazakizumab will be given no later than day 3. Clazakizumab: Dose is 25mg intravenously over 30 minutes. The first dose will be administered as soon as possible after the patient is enrolled and randomized into the Placebo arm. The route of administration will be intravenous. Each dose will be administered as an infusion that is run over 30 minutes. Serum CRP will be evaluated at baseline and on days 1 and 2 following clazakizumab administration. If the CRP does not decrease by 50% within 36-48 hours after the first dose, a second dose of placebo will be given no later than day 3. Placebo: Intravenously administered over 30 minutes.
    Measure Participants 0 0
    9. Secondary Outcome
    Title Patient Survival
    Description Number of participants alive at day 28.
    Time Frame 28 days

    Outcome Measure Data

    Analysis Population Description
    Study stopped due to no further development. Data was not analyzed or disclosed due to subject confidentiality being an issue (n=1). Assignment was not unblinded/disclosed.
    Arm/Group Title Clazakizumab 25 mg Placebo
    Arm/Group Description The first dose will be administered as soon as possible after the patient is enrolled and randomized into the Clazakizumab 25 mg arm. The route of administration will be intravenous. Each dose will be administered as an infusion that is run over 30 minutes. Serum C-reactive protein (CRP) will be evaluated at baseline and on days 1 and 2 following clazakizumab administration. If the CRP does not decrease by 50% within 36-48 hours after the first dose, a second dose of 25 mg clazakizumab will be given no later than day 3. Clazakizumab: Dose is 25mg intravenously over 30 minutes. The first dose will be administered as soon as possible after the patient is enrolled and randomized into the Placebo arm. The route of administration will be intravenous. Each dose will be administered as an infusion that is run over 30 minutes. Serum CRP will be evaluated at baseline and on days 1 and 2 following clazakizumab administration. If the CRP does not decrease by 50% within 36-48 hours after the first dose, a second dose of placebo will be given no later than day 3. Placebo: Intravenously administered over 30 minutes.
    Measure Participants 0 0
    10. Secondary Outcome
    Title Patient Survival
    Description Number of participants alive at day 60, end of study.
    Time Frame 60 days

    Outcome Measure Data

    Analysis Population Description
    Study stopped due to no further development. Data was not analyzed or disclosed due to subject confidentiality being an issue (n=1). Assignment was not unblinded/disclosed.
    Arm/Group Title Clazakizumab 25 mg Placebo
    Arm/Group Description The first dose will be administered as soon as possible after the patient is enrolled and randomized into the Clazakizumab 25 mg arm. The route of administration will be intravenous. Each dose will be administered as an infusion that is run over 30 minutes. Serum C-reactive protein (CRP) will be evaluated at baseline and on days 1 and 2 following clazakizumab administration. If the CRP does not decrease by 50% within 36-48 hours after the first dose, a second dose of 25 mg clazakizumab will be given no later than day 3. Clazakizumab: Dose is 25mg intravenously over 30 minutes. The first dose will be administered as soon as possible after the patient is enrolled and randomized into the Placebo arm. The route of administration will be intravenous. Each dose will be administered as an infusion that is run over 30 minutes. Serum CRP will be evaluated at baseline and on days 1 and 2 following clazakizumab administration. If the CRP does not decrease by 50% within 36-48 hours after the first dose, a second dose of placebo will be given no later than day 3. Placebo: Intravenously administered over 30 minutes.
    Measure Participants 0 0
    11. Secondary Outcome
    Title Number of Patients With Hemodialysis
    Description
    Time Frame 60 days

    Outcome Measure Data

    Analysis Population Description
    Study stopped due to no further development. Data was not analyzed or disclosed due to subject confidentiality being an issue (n=1). Assignment was not unblinded/disclosed.
    Arm/Group Title Clazakizumab 25 mg Placebo
    Arm/Group Description The first dose will be administered as soon as possible after the patient is enrolled and randomized into the Clazakizumab 25 mg arm. The route of administration will be intravenous. Each dose will be administered as an infusion that is run over 30 minutes. Serum C-reactive protein (CRP) will be evaluated at baseline and on days 1 and 2 following clazakizumab administration. If the CRP does not decrease by 50% within 36-48 hours after the first dose, a second dose of 25 mg clazakizumab will be given no later than day 3. Clazakizumab: Dose is 25mg intravenously over 30 minutes. The first dose will be administered as soon as possible after the patient is enrolled and randomized into the Placebo arm. The route of administration will be intravenous. Each dose will be administered as an infusion that is run over 30 minutes. Serum CRP will be evaluated at baseline and on days 1 and 2 following clazakizumab administration. If the CRP does not decrease by 50% within 36-48 hours after the first dose, a second dose of placebo will be given no later than day 3. Placebo: Intravenously administered over 30 minutes.
    Measure Participants 0 0
    12. Secondary Outcome
    Title Number of Patients With Continuous Renal Replacement Therapies (CRRT)
    Description
    Time Frame 60 days

    Outcome Measure Data

    Analysis Population Description
    Study stopped due to no further development. Data was not analyzed or disclosed due to subject confidentiality being an issue (n=1). Assignment was not unblinded/disclosed.
    Arm/Group Title Clazakizumab 25 mg Placebo
    Arm/Group Description The first dose will be administered as soon as possible after the patient is enrolled and randomized into the Clazakizumab 25 mg arm. The route of administration will be intravenous. Each dose will be administered as an infusion that is run over 30 minutes. Serum C-reactive protein (CRP) will be evaluated at baseline and on days 1 and 2 following clazakizumab administration. If the CRP does not decrease by 50% within 36-48 hours after the first dose, a second dose of 25 mg clazakizumab will be given no later than day 3. Clazakizumab: Dose is 25mg intravenously over 30 minutes. The first dose will be administered as soon as possible after the patient is enrolled and randomized into the Placebo arm. The route of administration will be intravenous. Each dose will be administered as an infusion that is run over 30 minutes. Serum CRP will be evaluated at baseline and on days 1 and 2 following clazakizumab administration. If the CRP does not decrease by 50% within 36-48 hours after the first dose, a second dose of placebo will be given no later than day 3. Placebo: Intravenously administered over 30 minutes.
    Measure Participants 0 0
    13. Secondary Outcome
    Title Number of Patients With Peritoneal Dialysis
    Description
    Time Frame 60 days

    Outcome Measure Data

    Analysis Population Description
    Study stopped due to no further development. Data was not analyzed or disclosed due to subject confidentiality being an issue (n=1). Assignment was not unblinded/disclosed.
    Arm/Group Title Clazakizumab 25 mg Placebo
    Arm/Group Description The first dose will be administered as soon as possible after the patient is enrolled and randomized into the Clazakizumab 25 mg arm. The route of administration will be intravenous. Each dose will be administered as an infusion that is run over 30 minutes. Serum C-reactive protein (CRP) will be evaluated at baseline and on days 1 and 2 following clazakizumab administration. If the CRP does not decrease by 50% within 36-48 hours after the first dose, a second dose of 25 mg clazakizumab will be given no later than day 3. Clazakizumab: Dose is 25mg intravenously over 30 minutes. The first dose will be administered as soon as possible after the patient is enrolled and randomized into the Placebo arm. The route of administration will be intravenous. Each dose will be administered as an infusion that is run over 30 minutes. Serum CRP will be evaluated at baseline and on days 1 and 2 following clazakizumab administration. If the CRP does not decrease by 50% within 36-48 hours after the first dose, a second dose of placebo will be given no later than day 3. Placebo: Intravenously administered over 30 minutes.
    Measure Participants 0 0

    Adverse Events

    Time Frame Up to 60 days
    Adverse Event Reporting Description Study stopped due to no further development. Data was not analyzed or disclosed due to subject confidentiality being an issue (n=1). Assignment was not unblinded/disclosed.
    Arm/Group Title Clazakizumab 25 mg Placebo
    Arm/Group Description The first dose will be administered as soon as possible after the patient is enrolled and randomized into the Clazakizumab 25 mg arm. The route of administration will be intravenous. Each dose will be administered as an infusion that is run over 30 minutes. Serum C-reactive protein (CRP) will be evaluated at baseline and on days 1 and 2 following clazakizumab administration. If the CRP does not decrease by 50% within 36-48 hours after the first dose, a second dose of 25 mg clazakizumab will be given no later than day 3. Clazakizumab: Dose is 25mg intravenously over 30 minutes. The first dose will be administered as soon as possible after the patient is enrolled and randomized into the Placebo arm. The route of administration will be intravenous. Each dose will be administered as an infusion that is run over 30 minutes. Serum CRP will be evaluated at baseline and on days 1 and 2 following clazakizumab administration. If the CRP does not decrease by 50% within 36-48 hours after the first dose, a second dose of placebo will be given no later than day 3. Placebo: Intravenously administered over 30 minutes.
    All Cause Mortality
    Clazakizumab 25 mg Placebo
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/0 (NaN) 0/0 (NaN)
    Serious Adverse Events
    Clazakizumab 25 mg Placebo
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/0 (NaN) 0/0 (NaN)
    Other (Not Including Serious) Adverse Events
    Clazakizumab 25 mg Placebo
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/0 (NaN) 0/0 (NaN)

    Limitations/Caveats

    Study was closed due to no further development. Data was not analyzed or disclosed due to subject confidentiality being an issue (n=1). Assignment was not unblinded/disclosed.

    More Information

    Certain Agreements

    All Principal Investigators ARE employed by the organization sponsoring the study.

    There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    Results Point of Contact

    Name/Title David J. Cohen, MD
    Organization Columbia University
    Phone 212-305-3273
    Email djc5@cumc.columbia.edu
    Responsible Party:
    Columbia University
    ClinicalTrials.gov Identifier:
    NCT04381052
    Other Study ID Numbers:
    • AAAT0142
    First Posted:
    May 8, 2020
    Last Update Posted:
    Apr 8, 2022
    Last Verified:
    Apr 1, 2022