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The Food and Drug Administration has suspended the authorization of the use of convalescent plasma in emergency situations in the treatment of COVID-19 patients. This decision was made after the intervention of leading federal health officials. Their arguments were simple: studies did not provide sufficient evidence for the effectiveness of the therapy. Although the decision may be changed in the future, it calls into question the further development of this treatment. And, as a consequence, to market drugs developed on the basis of plasma.
While plasma has been effective in treating a variety of diseases, COVID-19 is uncertain
Plasma, used since the 90s in the treatment of infectious diseases, was highly appreciated by the community of microbiologists and immunologists working to develop treatments for COVID-19. Scientists were guided by an analogous successful therapy of two other coronaviruses – MERS and SARS, and influenza.
The American Mayo clinic is at the forefront of plasma treatment. It is also where analyzes of tens of thousands of cases come from, showing that it is effective and safe.
The latest data from their program includes descriptions of over 35. COVID-19 patients. Many in the intensive care unit connected to ventilators. According to these studies, plasma administered within three days of the diagnosis of coronavirus infection significantly reduces mortality. In patients who received them within 3 days of diagnosis, it was 21,6%, and in the case of those who received plasma later, 26,7%.
However, these studies did not include a placebo-controlled group. Therefore, its results cannot be compared with those of patients who received plasma, which significantly complicates the scientific evaluation of the effectiveness of the treatment.
- All donors’ blood will be tested for COVID-19 antibodies
Given the limited access to plasma, it is not known if it could even treat all those in need within three days of diagnosis.
The Polish company Biomed from Lublin, which has just started the production of a Polish drug based on COVID, had similar problems with obtaining a sufficient amount of plasma for convalescents. The initial launch date of the production line was set for July, and the necessary plasma was not obtained until August.
Withholding plasma treatment does not mean you have to stop altogether
An authorization for an emergency use does not need to be based on as strong a scientific basis as a full release for use. Previously, the FDA approved the treatment of COVID-19 with anti-malaria drugs. However, already in June this year. changed her mind as both hydroxychloroquine and chloroquine have been proven ineffective in treating COVID-19.
Attempts to treat patients with plasma from convalescents began in the US in March. Since then, the therapy has been used. According to USCovidPlasma.org, plasma has received almost 67. people, and 14 thousand. doctors use it as part of a program run by the Mayo Clinic. Research is ongoing.
President Trump and members of the U.S. government’s coronavirus task force, and even celebrities, have encouraged people who have recovered from COVID-19 to donate plasma. The US government has invested heavily in developing experimental therapies. Plasma Technologies LLC received a contract worth 750 thousand. USD. A stock of 200 thousand. convalescent plasma, and the Department of Defense has announced it intends to stockpile more.
We are waiting for reliable research results
American decision makers emphasize that in the matter of plasma, they await the presentation of reliable data obtained from randomized clinical trials. In a randomized trial, patients are randomly assigned to a specific group to be assessed, and then the occurrence of specific endpoints is observed.
Meanwhile, we have random surveys. So: a March study showed improvement in four of the five patients given convalescent plasma. In the following May, 10 Chinese patients, published in Proceedings of the National Academy of Sciences, all reported improvements. The next May with 25 Houston patients showed that their condition had improved, plasma was effective and safe. It was similar with the study with the participation of 5 thousand. hospitalized patients.
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However, not all publications reach the same conclusions. The results of the Chinese study in June show improvement in only some patients. Another randomized trial involving 103 Chinese patients showed no statistically significant improvement in their condition. In this case, the result was also influenced by problems with recruiting a sufficient number of patients.
According to the survey, 35 thousand In patients published this month, early plasma dosing reduced deaths more effectively, confirming the observations of doctors at the Mayo Clinic. Weekly mortality was 3% for people who received a transfusion within 8,7 days of diagnosis, and 4% for patients treated with plasma 11,9 days or more after diagnosis. However, also in this case there was no placebo group.
“Plasma from convalescents has not been proven beyond reasonable doubt.” We don’t have randomized follow-up studies, says Dr. Ian Lipkin, director of the Center for Infection and Immunity at Columbia University Mailman School of Public Health. – As long as they are not there, one has to show healthy skepticism.
This example shows how important it is to thoroughly research a Polish drug before and after administering it to patients. The more so because it is to be safer than plasma and contain standardized doses of antibodies. The Lublin company estimates that the first patients will receive it in 8 weeks.
Read also:
- “We are the first in the world to start the production of a COVID-19 drug”. What do we know about him?
- “He is in great shape and will be leaving hospital soon.” Prof. Tomasiewicz about the first COVID-19 patient who received plasma
- The first drug for COVID-19 will come from plasma. Does such therapy work against the virus?
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