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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT04361552
Other study ID # STUDY00000419
Secondary ID NCI-2020-02314WI
Status Withdrawn
Phase Phase 3
First received
Last updated
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
Health authority
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Status Withdrawn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)

Study Design


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
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