One of the dreaded complications in patients with severe Covid 19 disease is a so-called “cytokine storm” with an overturning inflammatory reaction that damages the whole body. Roche is now investigating the effectiveness of the biotech polyarthritis drug tocilizumab.
There are many concepts for the treatment of Covid-19 by SARS-CoV-2 pathogens, as well as many anecdotal findings from the time of SARS (2002/2003) and MERS (from 2012). However, clinical studies under placebo control with random allocation of the test subjects are consistently absent. So the knowledge of the effectiveness so far is patchwork.
Roche wants to start a classic study of the effectiveness of the biotech drug with a large-scale study using the monoclonal antibody tocilizumab. It will begin with a randomized (random allocation of subjects) double-blind (neither doctor nor patient know who gets what) and placebo-controlled phase III study to ensure safety and efficacy of an intravenous administration of the drug in «hospitalized patients with severe To investigate Covid 19 disease, »said the company.
330 human “guinea pigs”
All admitted patients receive the best standard therapy plus the monoclonal antibody or placebo and are followed for 60 days. The study, which has been approved by the US Food and Drug Administration, is expected to enroll approximately 330 patients. Development of the clinical picture, mortality, duration of the necessary artificial ventilation and length of stay in intensive care units are the evaluation parameters. The scientific investigation is scheduled to start in early April.
Tocilizumab is a monoclonal antibody that has been used for years with good results in the treatment of moderate to moderate chronic polyarthritis. The active substance blocks the receptor for the inflammatory immune messenger interleukin-6 (IL-6) and is intended to cut off the inflammation signaling cascade in the event of excessive inflammation. This is what comes to the fore in sepsis or a “cytokine storm”.
In a scientific report in the British medical journal “The Lancet” it was noted only a few days ago that high interleukin 6 values in the blood were observed in 150 patients with severe Covid 19 disease in China. This would indicate a hyperinflammatory response caused by SARS-CoV-2.
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