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

Coronary Artery Disease Clinical Trial

Official title:

Tociluzumab for Cytokine Release Syndrome With SARS-CoV-2: An Open-Labeled, Randomized Phase 3 Trial

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04361552
• Other study ID #: STUDY00000419
• Secondary ID: NCI-2020-02314WI
• Status: Withdrawn
• Phase: Phase 3
• Start date: April 7, 2020
• Est. completion date: June 2, 2020

Study information

• Verified date: June 2020
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2, 2020
• Est. primary completion date: June 2, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Cerebrovascular Accident
• Chronic Obstructive Pulmonary Disease
• Chronic Renal Failure
• Coronary Artery Disease
• Diabetes Mellitus
• Infection
• Kidney Failure, Chronic
• Lung Diseases, Obstructive
• Malignant Neoplasm
• Neoplasms
• Pulmonary Disease, Chronic Obstructive
• SARS Coronavirus 2 Infection
• Stroke

Intervention

Other:
• Best Practice
Receive standard of care

Biological:
• Tocilizumab
Given IV

Locations

Country	Name	City	State
United States	Emory University Hospital/Winship Cancer Institute	Atlanta	Georgia

Sponsors (2)

Lead Sponsor	Collaborator
Emory University	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	7-day length of invasive mechanical ventilation (MV)	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.	Up to 7 days
Primary	30-day mortality rate	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.	Up to 30-day after randomization
Secondary	Rate of intensive care (ICU) transfer	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.	Up to 2 years
Secondary	Rate of invasive mechanical ventilation	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.	Up to 2 years
Secondary	Rate of tracheostomy	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.	Up to 2 years
Secondary	Length of ICU stay	Will first be described by median and inter-quartile, and then compared between two arms by Wilcoxon Sum-Rank test	Up to 2 years
Secondary	Length of hospital stay		Up 2 years