France authorizes “exceptional use” of plasma therapy outside clinical trials


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                Le gaz de l'agence française des médicaments a donné son feu vert au plasma sanguin des patients guéris de Covid-19 pour être utilisé pour traiter ceux qui sont gravement malades de la maladie - bien que dans des conditions strictes.

L'agence nationale pour la sécurité des médicaments et des produits de santé (ANSM) a déclaré jeudi qu'elle autoriserait une thérapie plasmatique immunitaire, qui n'a jusqu'à présent été autorisée que dans les essais cliniques, à être utilisée "temporairement".

The idea is to transfer anti-virus antibodies from the blood of a person who has recovered from the virus to a newly sick person who does not yet have these antibodies.

The method has been used for more than a century to treat diphtheria, Spanish flu, measles and chickenpox.

“Given the potential severity of Covid-19 disease and in order to increase the chances of survival of patients with a severe form of the disease”, the ANSM indicated that it had decided to “regulate exceptional use and temporary recovery of plasma from convalescents outside of ongoing clinical trials ”.

The agency acknowledged that, to date, the effectiveness of plasma transfusions in the fight against Covid-19 has not been demonstrated.

The clinical trials which began in early April under the supervision of the Assistance Publique-Hôpitaux de Paris, the French Blood Establishment and the National Institute of Health and Medical Research aim to assess “the effectiveness and security ”of technique.

According to the ANSM, the data suggest that the plasma of people who have recovered from Covid-19 could improve the survival rate of patients infected with SARS-CoV-2, the medical name of the coronavirus.

The U.S. Food and Drug Administration has also given the green light to test plasma treatments for the coronavirus, while plasma transfusions have been performed on some patients in China.

France is one of the countries most affected by the coronavirus, with more than 24,000 deaths and some 130,000 confirmed cases.



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