France to allow 'exceptional use' of plasma therapy outside of clinical trials
France's drug agency gas given the green light for blood plasma from cured Covid-19 patients to be used to treat those who are critically ill with the disease – albeit under strict conditions.
The National Agency for Medicines and Health Products Safety (ANSM) on Thursday said it would allow immune plasma therapy, which has so far only been authorised in clinical trials, to be used "temporarily".
The idea is to transfer the virus-fighting antibodies from the blood of someone who has recovered from the virus to a newly sick person, who does yet have those antibodies.
The method has been used by more than a century to treat diphtheria, the 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 severe form of the disease", the ANSM said it had decided to "regulate the exceptional and temporary use of plasma from convalescent people outside of ongoing clinical trials”.
#Covid19— ANSM (@ansm) April 30, 2020
Nous encadrons l’utilisation à titre exceptionnel et temporaire du #plasma de personnes convalescentes en dehors des #EssaisCliniques en cours
En savoir ➕ https://t.co/aAJ4e7uOqL pic.twitter.com/tW4bZ7M09h
The agency conceded that to date, the effectiveness of plasma transfusions in the fight against Covid-19 has not been demonstrated.
Clinical trials that began in early April under the supervision of the Public Assistance-Hospitals of Paris, the French Blood Establishment and the National Institute of Health and Medical Research are aimed at evaluating the "efficacy and safety" of the technique.
According to ANSM, data suggests 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 US Food and Drug Administration has also given the green light to test plasma treatments against the coronavirus, while plasma transfusions have been performed on some patients in China.
France is among the countries worst hit by the coronavirus, with more than 24,000 fatalities and some 130,000 confirmed cases.
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