A study to evaluate TCZ in patients with severe COVID-19 Pneumonia
A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE SAFETY AND EFFICACY OF TOCILIZUMAB IN PATIENTS WITH SEVERE COVID-19 PNEUMONIA
Funder: F. Hoffmann-La Roche Ltd
Sponsor: F. Hoffmann-La Roche Ltd
Approval Date: 26 March 2020
This study aims to see whether treatment with Tocilizumab helps patients with COVID-19. Toclizumab is a medicine that blocks the action of a protein (interleukin-6) involved with the immune system. The study will look at how effective and how safe Tocilizumab is compared with placebo (no active ingredient) in patients with COVID-19 pneumonia. The study will enrol 330 patients from 9 countries. In the UK, about 60 patients will take part, from 8 different hospitals. All patients will receive normal hospital treatment as well as one of the following treatments, chosen by chance: Group 1 will receive Toclizumab, given as one or two infusions (into a vein). There is a 2 in 3 chance of being in this group Group 2 will receive placebo, given as one or two infusions (into a vein). There is a 1 in 3 chance of being in this group. Patient information, including blood pressure, pulse rate, temperature, blood oxygen levels, level of consciousness (awareness) and breathing status will be collected daily for 28 days. Weekly Laboratory tests, and swabs from the upper throat, behind the nose (nasopharyngeal) will be collected daily for the first week and then weekly for 28 days. Heart and lungs will be assessed by ECG (electrocardiogram) at screening, Chest X-ray and CT (computerised tomography) scan weekly for 28 days. There will be further assessments on Day 35, Day 45 and when the study finishes on Day 60. The study will also monitor other effects on the body such as C-reactive protein (which is an indicator of the level of inflammation), and how the drug is changed in the body (pharmacokinetics) The study is paid for by F. Hoffmann-La Roche Ltd.
This study will evaluate the efficacy, safety, pharmacodynamics, and pharmacokinetics of tocilizumab (TCZ) compared with a matching placebo in combination with standard of care (SOC) in hospitalized patients with severe COVID-19 pneumonia.
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