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The FDA or the Food and Drug Administration in the United States have now decided to expand their rules on the usage of experimental treatments that involved the novel coronavirus or COVID-19.
The FDA will now be including the use of convalescent plasma, in situations wherein a patient is seriously and critically ill or their lives are immediately threatened.
Though this in no way an approval for a certified treatment, but rather a precautionary measure or emergency clearance that is only administered on a severe and acute case-by-case basis. This will be considered to be a means of aiding future research that is being developed to the possible efficacy of plasma that is being collected from patients who have recovered from COVID-19.
Human blood has a component called plasma. This is the liquid part that contains antibodies that add or contribute to the body's immune system response. Though, the use of plasma through direct transfusion has not yet met with clinical studies as of now that is need to present that it actually works and is effective and safe for fighting the coronavirus.
Even though this is the current case, the FDA will still allow and has granted temporary authorization under the eINDS or the Investigational New Drug Applicants exemption in response to the widely known dangers and nature of the coronavirus pandemic.
To try and fight off other diseases, people who had viruses back then and have actually recovered from it eventually, have already been immune to it, just like with chickenpox for the long-term and seasonal flu for the short-term. It is, at least in theory, possible to take the anti-bodies from a person who has already developed it, and transfer them into a patient who has a weak immune system and fails to produce its own.
The convalescent plasma transfusions have also been used numerous times in previous outbreaks which include MERS, SARS and the H1N1 with different results.
With regards to the use of plasma against COVID-19, there has been a handful of research projects that are now ongoing, for example, a study that was published by a team of Chinese medical professionals that have studied a group of ten individuals who were in critical condition and received donations from previously recovered patients.
Results in that study have found that in five of the ten cases they handled, the level of antibodies has heightened expeditiously post-transfusion. After a week, the virus could not be detected from at least seven patients.
When compared to small investigations from clinical practices, they have all seem to produce the same results, even though this is not a formal clinical study. To ensure that all medical experts that are working with donors and recipients are following the same playbook, some protocols have been put together to help align efforts in various investigations.
With a vast variety of treatments that are currently under development, there is no doubt that this will take a lof time to do testing and research to certify and validate the use of the plasma.
The convalescent plasma may not be that sophisticated or refined but it does give out possibilities and advantages of being relatively safe and should be something to look out for.