The overall objective is to evaluate the clinical efficacy and safety of tocilizumab relative to placebo among approximately 300 hospitalized adult patients who have severe COVID-19. The study will be a 2 arm double blinded comparison between tocilizumab 8 mg/kg and matching placebo IV. The dose may be repeated in 8-12 hours if clinical symptoms worsens, (e.g. increase in oxygen requirements). Participants will be followed for 28 days.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
20
Participants will receive 1 dose of IV TCZ. 1 additional dose may be given if clinical symptoms worsen.
Participants will receive 1 dose of IV placebo matched to TCZ. Up to 1 additional dose may be given if clinical symptoms worsen.
Queen's Medical Center
Honolulu, Hawaii, United States
Clinical status (on a 7-point ordinal scale) at day 28
Clinical Status 7-point ordinal scale: 1. Not hospitalized, no limitations on activities 2. Not hospitalized, limitation on activities 3. Hospitalized, not requiring supplemental oxygen 4. Hospitalized, requiring supplemental oxygen 5. Hospitalized, on non-invasive ventilation or high flow oxygen devices 6. Hospitalized, on invasive mechanical ventilation or ECMO 7. Death
Time frame: up to day 28
Clinical improvement
ii. Time to clinical improvement, defined as a National Early Warning Score (NEWS) of \< 2 maintained for 24 hours iii. Time to clinical improvement of at least 2 categories relative to baseline on a 7-category ordinal scale of clinical status
Time frame: up to day 28
Mechanical Ventilation
iv. Incidence of mechanical ventilation v. Ventilator-free days
Time frame: up to day 28
Oxygenation
vi. Duration of time on supplemental oxygen
Time frame: up to day 28
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