The immunomodulatory drug tocilizumab has shown to be effective in preventing “an inflammatory storm” in Covid-19 patients in serious condition, according to a French study not yet published, the first results of which were released on Monday.
This treatment “significantly” reduced the proportion of patients who had to be transferred to intensive care or died, compared to those who received standard treatment, said the Assistance Publique-Hôpital de Paris (AP-HP).
This is the “first randomized controlled trial” that “demonstrates clinical benefit” of this treatment in Covid patients with severe infections, the organizers said.
Pending consolidation of results
These results have yet to be “consolidated” and will be published in a scientific journal in a few weeks. But the AP-HP explains that it has decided to make them public now “for reasons of public health”, due to the context of the pandemic crisis, and to have communicated them to French health authorities and to the World Health Organization ( WHO).
Tocilizumab (Actemra or RoActemra) from the Roche laboratory belongs to the family of monoclonal antibodies – antibodies created in the laboratory, produced from a single strain of lymphocytes and designed to respond to a specific target.
Usually used to treat rheumatoid arthritis, it works by blocking the receptor for a protein in the immune system that plays an important role in the inflammatory process.
A study of 129 patients
Some patients with the new coronavirus experience a sudden worsening of their condition after several days, which causes acute respiratory distress, a phenomenon probably linked to an excessive immune reaction of the organism.
129 people hospitalized in 13 hospitals were included in the study: Covid patients with “moderate to severe” pneumonia who needed oxygen assistance.
This profile corresponds “only to 5% to 10% of patients infected” by the coronavirus, but they are among those who are most at risk of being placed on artificial respiration or dying, said Xavier Mariette, co-investigator study coordinator.
Half of the participants received one or two injections of tocilizumab in addition to the standard treatment (oxygen, antibiotics and anticoagulants), while the other half received only standard care.
They were then followed for 14 days to obtain these intermediate results, a follow-up which will continue to confirm the conclusions.
A high price to put into perspective
At this stage, the researchers did not observe more undesirable side effects in patients who received the immunomodulator than in those who received the standard treatment, underlined Prof. Mariette.
Other teams have already reported encouraging results concerning tocilizumab, at Foch hospital in particular, but these were “open” studies, without a control group drawn at random, which bring “not the same level of evidence “and” do not allow to define a standard of treatment “, underlined the researchers from AP-HP.
The current cost of tocilizumab is around 800 euros per injection, a high price but much less than that of a day in hospital in an intensive care unit, they said.
A comparable drug, sarilumab (Kevzara), developed by Sanofi and Regeneron is also being tested in the same clinical trial program, called CORIMMUNO, and the first results should be known “within the next few days”, according to Pr Mariette.
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