COVID-19 Clinical Trial
Official title:
A Nested Interventional Cohort Study to Assess the Efficacy and Safety of Adjunctive Humanized Monoclonal Interleukin-6 Receptor Blocker Tocilizumab (TCZ) Therapy to Standard of Care for the Reduction of Hyperinflammation Related Mortality in SARS-Cov2 Positive Patients
This is a cohort study of COVID-19 patients with hyperinflammation. It aims to determine the impact of adjunctive Tocilizumab (TCZ) to standard of care on the reduction of hyperinflammation-related mortality in COVID-19. Patients with COVID-19 are at high risk of life-threatening hyperinflammation and death. One in three COVID-19 patients admitted to ICU was found to develop life-threatening hyperinflammation. The risk of death when untreated is estimated to be 50-80%.
The novel coronavirus, SARS-Cov2/COVID-19, emerged in late 2019 in Wuhan, China. Quickly,
SARS-CoV2 spread to all corners of the globe. In March 2020, The World Health Organization
(WHO) declared SARS-CoV2/COVID-19 a pandemic. Individuals infected with SARS-CoV2 have a
varied clinical presentation, ranging from asymptomatic or mild respiratory symptoms to
severe involvement of the lower respiratory tract, with patients requiring mechanical
ventilation. A particular point of interest is how the overall severity and clinical outcomes
of COVID-19 patients may be associated with the excessive production of pro-inflammatory
cytokines, or hyperinflammation, leading to acute respiratory distress syndrome. This state
of hyperinflammation may be associated with increased mortality in COVID-19 patients.
Tocilizumab, an Interleukin-6 antagonist, may help treat COVID-19 associated
hyperinflammation.
This is a nested interventional cohort study of COVID-19 patients with hyperinflammation. It
aims to determine the impact of adjunctive Tocilizumab (TCZ) to standard of care on the
reduction of hyperinflammation-related mortality in COVID-19. Patients with COVID-19 are at
high risk of life-threatening hyperinflammation and death. One in three COVID-19 patients
admitted to ICU was found to develop life-threatening hyperinflammation. The risk of death
when untreated is estimated to be 50-80%. TCZ treatment may reduce mortality.
Primary objective: To establish that tocilizumab, in addition to standard of care, reduces
the 30-day mortality from hyperinflammation in COVID-19 disease significantly compared to no
anti-interleukin therapy plus standard of care.
Secondary objectives: To evaluate the addition of tocilizumab therapy to standard of care on
a number of secondary outcomes.
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