Finding studies
Finding studies
Take this into the appointment.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Lead
National Cancer Institute (NCI)
PRIMARY OBJECTIVES: I. To enhance access to tocilizumab for patients who cannot participate in the randomized COVACTA trial with specific emphasis on patients with cancer, especially those who belong to high-risk and minority populations and children. II. To provide observations on clinical outcomes associated with tocilizumab administration in cancer patients with severe acute respiratory syndrome (SARS) coronavirus 2 (COVID-19) disease. SECONDARY OBJECTIVE: I. To estimate the proportion of patients whose level of institutional care does not further escalate following administration of tocilizumab. EXPLORATORY OBJECTIVES: I. To estimate the number of days intensive care unit (ICU) patients spent in the ICU. II. To evaluate the mortality rate of patients: IIa. 30-day and 60-day mortality in patients in the ICU. IIb. Evaluate the 14-, 30- and 60-day mortality rate following infusion of tocilizumab. III. To evaluate overall survival. IV. To describe the proportion of patients progressing to ventilator support after tocilizumab therapy. V. Evaluate the clinical course following administration of tocilizumab. Va. To evaluate the development of additional infections. Vb. To evaluate the side effects following tocilizumab. Vc. To evaluate impact on inflammatory markers. VI. Evaluate the duration of time: VIa. To removal from mechanical ventilator support. VIb. To step-down of institutional care requirements. VIc. To discharge from the ICU to lower level. VId. To hospital discharge. VIe. To resolution of clinical symptoms. VIf. To time of defervescence. VIg. To normalization of disease-related laboratory abnormalities. VII. Exploratory biologic correlates. VIIa. To evaluate cytokine levels pre and post-tocilizumab, specifically evaluating IL-6. VIIb. To evaluate SARS-coronavirus (CoV)-2 viral loads pre and post-tocilizumab. VIIc. To determine the pharmacokinetics of tocilizumab in order to facilitate exposure-response analysis. VIId. To correlate clinical outcomes with changes in cytokine levels and SARS-CoV-2 viral loads. OUTLINE: Patients receive tocilizumab intravenously (IV) over 60 minutes. A second dose may be given if there is sustained or recurrent fever, no decrease or not more than a 1-category improvement on the 7-category ordinal scale (only stabilization or partial improvement following first dose), or a \>= 1-category worsening on the 7-category ordinal scale from nadir. After completion of study treatment, patients are followed up for at least 60 days, and, when possible, up to 1 year.
Age
2–any
Sex
ALL
Healthy volunteers
Not accepted
