Due to unexplained excess mortality among participants, the clinical trial evaluating the effects of the drug anakinra in the management of Covid-19 is suspended.
Initially intended for rheumatic diseases, it had given "encouraging" results for severe forms of the disease by reducing the risk of death.
A clinical trial in France evaluating the drug anakinra in the treatment of Covid-19 is suspended due to unexplained excess mortality among patients treated according to preliminary results of the trial, indicates the drug agency ANSM.
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"Encouraging" results for severe forms of Covid-19 disease
This drug, anakinra (trade name: Kineret), initially intended for rheumatic diseases, had given "encouraging" results for severe forms of Covid-19 disease by significantly reducing the risk of death and the need for '' be put on a ventilator in intensive care, according to a study by a French medical team from the Paris Saint-Joseph Hospital Group (GHPSJ), published in the specialized journal The Lancet Rheumatology.
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A drug still effective for other pathologies
This safety information does not call into question the benefit / risk ratio of anakinra when it is used in the validated indications of its marketing authorization (AMM) such as for example for rheumatoid arthritis, underlines the ANSM. .
"Patients treated for one of these pathologies can therefore continue their treatment".
"If symptoms suggestive of Covid-19 appear", the health agency invites them to consult their doctor.
Early excess mortality
The ANACONDA-COVID-19 trial conducted by the Tours University Hospital involves around thirty patients.
The interim review of data showed early excess mortality in the group of patients treated with anakinra compared to the group who did not receive this drug.
"A deleterious effect of anakinra cannot be excluded insofar as the information available at this stage does not make it possible to explain this difference" between these two groups of patients, notes the ANSM.
Anakinra targets, to block it, one of the cytokines, interleukin-1 (IL-1) involved in the "inflammatory storm" which results in acute respiratory distress syndrome (ARDS) requiring the assistance of a physician. artificial ventilation with the use of respirator.
The other clinical trials with anakinra authorized in France in the Covid-19 indication are also suspended.
These clinical trials were however already stopped or had not yet started, specifies the health agency.
Finally, the ANSM "reminds healthcare professionals that at present, no study shows the interest of its use in the care of Covid patients".