Covid-19: Suspension in France of a clinical trial after early excess mortality

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A clinical trial in France evaluating an antirheumatic drug in the management of Covid-19 has been suspended due to unexplained excess mortality among patients treated according to the trial’s preliminary results, the drug agency said Thursday. (ANSM).

The clinical trial on anakinra, a drug already authorized on the French market to treat rheumatic diseases, was conducted by the Tours University Hospital on around thirty patients.

After “promising” results, he was suspended due to early excess mortality among treated volunteers, the drug agency added.

This drug, marketed under the name Kineret, had given “encouraging” results for severe forms of Covid-19 disease by significantly reducing the risk of death and the need to be put on a ventilator in intensive care, according to a study of a French medical team from the Paris Saint-Joseph Hospital Group (GHPSJ), published in the specialist journal The Lancet Rheumatology.

According to the ANSM, this safety information does not call into question the benefit/risk ratio of anakinra used in the validated indications of its marketing authorization (AMM), such as, for example, for rheumatoid arthritis.

The health agency also specified that 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 ANSM.