Tocilizumab for the Treatment of Cytokine Release Syndrome in Patients With COVID-19 (SARS-CoV-2 Infection)
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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Withdrawn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
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Condition or disease | Intervention/treatment | Phase |
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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 |
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 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 |

Arm | Intervention/treatment |
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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.
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Other: Best Practice
Receive standard of care
Other Names:
Biological: Tocilizumab Given IV
Other Names:
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Active Comparator: Arm II (standard of care)
Patients receive standard of care.
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Other: Best Practice
Receive standard of care
Other Names:
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- 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.
- 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.
- 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.
- 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.
- 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.
- 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
- Length of hospital stay [ Time Frame: Up 2 years ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Diagnosis with SARS-CoV-2 by the currently available assays (Food and Drug Administration [FDA] approved)
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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)

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
United States, Georgia | |
Emory University Hospital/Winship Cancer Institute | |
Atlanta, Georgia, United States, 30322 |
Principal Investigator: | Ajay K Nooka | Emory University Hospital/Winship Cancer Institute |
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. |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
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 |