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Tocilizumab for the Treatment of Cytokine Release Syndrome in Patients With COVID-19 (SARS-CoV-2 Infection)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04361552
Recruitment Status : Withdrawn (Study abandoned due to drug billing issues)
First Posted : April 24, 2020
Last Update Posted : June 18, 2020
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Ajay Nooka, Emory University

Study Description
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Brief Summary:
This phase III trial compares the effect of adding tocilizumab to standard of care versus standard of care alone in treating cytokine release syndrome (CRS) in patients with SARS-CoV-2 infection. CRS is a potentially serious disorder caused by the release of an excessive amount of substance that is made by cells of the immune system (cytokines) as a response to viral infection. Tocilizumab is used to decrease the body's immune response. Adding tocilizumab to standard of care may work better in treating CRS in patients with SARS-CoV-2 infection compared to standard of care alone.

Condition or disease Intervention/treatment Phase
Cerebrovascular Accident Chronic Obstructive Pulmonary Disease Chronic Renal Failure Coronary Artery Disease Diabetes Mellitus Malignant Neoplasm SARS Coronavirus 2 Infection Other: Best Practice Biological: Tocilizumab Phase 3

Detailed Description:

PRIMARY OBJECTIVE:

I. To decrease the length of invasive mechanical ventilation (MV) and rate of 30-day mortality from CRS due to SARS-CoV-2.

SECONDARY OBJECTIVES:

I. To decrease the rates of intensive care unit (ICU) transfer. II. To decrease the rate of invasive mechanical ventilation (MV). III. To decrease the length of ICU stay. IV. To decrease the rate of tracheostomy. V. Safety and efficacy of tociluzumab. VI. Biomarker assessment for response.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients receive tocilizumab intravenously (IV) every 12 hours for up to 3 doses in the absence of disease progression or unacceptable toxicity. Patients also receive standard of care.

ARM II: Patients receive standard of care.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Tociluzumab for Cytokine Release Syndrome With SARS-CoV-2: An Open-Labeled, Randomized Phase 3 Trial
Actual Study Start Date : April 7, 2020
Actual Primary Completion Date : June 2, 2020
Actual Study Completion Date : June 2, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Tocilizumab

Arms and Interventions
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Arm Intervention/treatment
Experimental: Arm I (tocilizumab, standard of care)
Patients receive tocilizumab IV every 12 hours for up to 3 doses in the absence of disease progression or unacceptable toxicity. Patients also receive standard of care.
 Other: Best Practice
Receive standard of care
Other Names:
  • standard of care
  • standard therapy

Biological: Tocilizumab
Given IV
Other Names:
  • Actemra
  • Immunoglobulin G1, Anti-(Human Interleukin 6 Receptor) (Human-Mouse Monoclonal MRA Heavy Chain), Disulfide with Human-Mouse Monoclonal MRA Kappa-Chain, Dimer
  • MRA
  • R-1569
  • RoActemra
Active Comparator: Arm II (standard of care)
Patients receive standard of care.
 Other: Best Practice
Receive standard of care
Other Names:
  • standard of care
  • standard therapy


Outcome Measures
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Primary Outcome Measures :
  1. 7-day length of invasive mechanical ventilation (MV) [ Time Frame: Up to 7 days ]
    The 7-day length of invasive MV for each arm will be estimated with 95% confidence intervals (CIs) using the exact binomial distribution. Their difference by the arms will be tested by Cochran-Mantel-Haenszel (CMH) test stratified by the age group and Sequential Organ Failure Assessment (SOFA) score at significance level of 0.05.

  2. 30-day mortality rate [ Time Frame: Up to 30-day after randomization ]
    Defined as death within 30-day after randomization. The 30-day mortality rate for each arm will be estimated with 95% CIs using the exact binomial distribution. Their difference by the arms will be tested CMH test stratified by the age group and SOFA score at significance level of 0.05.


Secondary Outcome Measures :
  1. Rate of intensive care (ICU) transfer [ Time Frame: Up to 2 years ]
    The rate of ICU transfer for each arm will be estimated with 95% CIs using the exact binomial distribution. Their difference by the arms will be tested CMH test stratified by the age group and SOFA score at significance level of 0.05.

  2. Rate of invasive mechanical ventilation [ Time Frame: Up to 2 years ]
    The rate of invasive mechanical ventilation for each arm will be estimated with 95% CIs using the exact binomial distribution. Their difference by the arms will be tested CMH test stratified by the age group and SOFA score at significance level of 0.05.

  3. Rate of tracheostomy [ Time Frame: Up to 2 years ]
    The rate of tracheostomy for each arm will be estimated with 95% CIs using the exact binomial distribution. Their difference by the arms will be tested CMH test stratified by the age group and SOFA score at significance level of 0.05.

  4. Length of ICU stay [ Time Frame: Up to 2 years ]
    Will first be described by median and inter-quartile, and then compared between two arms by Wilcoxon Sum-Rank test

  5. Length of hospital stay [ Time Frame: Up 2 years ]

Eligibility Criteria
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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

Inclusion Criteria:

  • Diagnosis with SARS-CoV-2 by the currently available assays (Food and Drug Administration [FDA] approved)

  • Should be hospitalized and exhibit at least one of the following predictors of mortality

    • Age >= 65 years
    • Current smoker (smoked >= 100 cigarettes in life and actively smoking)
    • Chronic obstructive pulmonary disease (COPD)
    • Diabetes
    • Hypertension
    • Coronary artery disease
    • Cerebrovascular accident (CVA)
    • Chronic renal disease (creatinine of >= 2 mg/dl)
    • Cancer
    • Patients that have C-reactive protein (CRP) >= 10 mg/L
    • D-dimer >= 0.5 mg/L
    • Procalcitonin >= 0.5 mg/L
    • Lactate dehydrogenase (LDH) >= upper limit of normal (ULN)
  • Patients or authorized family member willing to sign informed consent to participate in this study

Exclusion Criteria:

  • Pregnant or lactating women
  • Hypersensitivity to tocilizumab
  • Patients or authorized family member unwilling to sign informed consent to participate in this study
  • Uncontrolled tuberculosis, or any uncontrolled fungal infection (eg: candidemia)
Contacts and Locations
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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): NCT04361552


Locations
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United States, Georgia
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Emory University
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Ajay K Nooka Emory University Hospital/Winship Cancer Institute
More Information
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Responsible Party: Ajay Nooka, Principal Investigator, Emory University
ClinicalTrials.gov Identifier: NCT04361552    
Other Study ID Numbers: STUDY00000419
NCI-2020-02314 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
WINSHIP4998-20 ( Other Identifier: Emory University Hospital/Winship Cancer Institute )
P30CA138292 ( U.S. NIH Grant/Contract )
First Posted: April 24, 2020    Key Record Dates
Last Update Posted: June 18, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Results of the trial and not individual patient data will be shared. The study protocol, consent, and investigator's brochure will be available. The statistical plan is incorporated into the protocol, along with inclusion and exclusion criteria.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Infections
COVID-19
Neoplasms
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Stroke
Kidney Failure, Chronic
Coronary Artery Disease
Cytokine Release Syndrome
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Coronary Disease
Myocardial Ischemia
Heart Diseases
 Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases