Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Emory University
With
National Cancer Institute (NCI)
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.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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)
