- Tram Ho
The U.S. Food and Drug Administration (FDA) today released an update on the use of experimental treatments on Covid-19 patients. Of which, most notably, they have officially allowed the transfusion of human plasma from patients to patients with serious, life-threatening symptoms of SARS-CoV-2 virus infection.
Although this is not an official approval of a validated and certified treatment for effective safety, it does help solve two problems at this time.
First, the FDA’s approval will help to make use of a ” living drug ” source of antibodies that are resistant to the SARS-CoV-2 virus in the plasma of Covid-19 patients after recovery. Often these antibodies do not persist for too long in their blood.
Second, plasma transfusion will probably save some Covid-19 patients, as this method has been shown to be effective by a number of small group trials. Further studies may also find additional results and statistics from these cases.
The US FDA allows the use of cured human plasma to treat critical cases of Covid-19
Plasma is a component of human blood – namely, the liquid part – which contains antibodies that make up our immune response. Currently, the method of transmitting plasma from patients to SARS-CoV-2 virus infected patients has not yet gone through the necessary clinical trial steps, to be proved safe and effective.
However, the FDA has temporarily granted authorization for this treatment through its waivers when applying for new drug testing (eINDS). In the eINDS, the FDA says drugs that are in clinical trial but not licensed can be used in emergencies, or serious situations when a patient’s life is threatened.
Situations like these can occur in the Covid-19 epidemic, while we still do not have any specific treatment for the disease. Meanwhile, a number of preclinical and clinical trials surrounding the transfer of plasma from cured patients to Covid-19 patients have shown promising results.
This is also not the first time a patient’s plasma has been used to help people who are ill. We know that people who have been infected with the virus can build immunity from the virus itself.
Some of the illnesses once recovered, the disease can retain immunity to it as long as chicken pox. While some other illnesses are shorter, for example, getting a seasonal flu infection this year will not keep you immune to it until next year.
Logically and theoretically, the transmission of plasma containing antibodies from a patient who has recovered from illness to the patient who is infected may be effective. This method has been used in previous outbreaks, including H1N1, SARS and MERS.
This method has been tested in China.
Scientists are conducting several plasma transfusion tests of Covid-19 patients who have recovered to patients who are still infected. The results of such a study in China published in the form of pre-published articles show:
5 out of 10 Covid-19 patients receiving plasma from the patients recovered quickly increased their antibody concentration. 4 other patients maintained antibody levels in the donor blood. Seven patients were negative for the virus after 1 week of treatment.
It is not yet an official clinical trial study, but several other small-scale studies have shown similar results.
To synchronize these studies, a team of doctors worked together to develop a set of principles that apply to both Covid-19 patients receiving and donating plasma. This will help to quickly standardize this process, if it is proven effective and approved.
In the US, New York governor Andrew Cuomo said health agencies in the state will begin a plasma transfusion test for Covid-19 patients as soon as this week. The trial was cited by FDA director Dr. Stephen Hahn as a promising area during a White House press conference.
All Covid-19 patients who have recovered from their illness and want to donate plasma will have to be tested to confirm that they are not at risk of transmitting the virus. Their blood must also be eligible for donation according to the applicable rules for blood donation.
Although some early studies have shown that plasma transfusions may have a preventive effect (meaning they used it to help people who have not been infected with Covid-19), the FDA strictly prohibits the use of plasma. in this case.
Like all treatments currently being developed against SARS-CoV-2 virus, plasma transfusions will undergo clinical trials before being approved for use in all diseases. multiply.
Studies so far show that plasma transfusion seems to be more effective in less advanced patients with Covid-19, than in critical patients. This method is not new, it has the advantage of being simple to implement and relatively safe.
Therefore, accelerating clinical trials to confirm its effectiveness will be a necessary direction in the context that the Covid-19 epidemic is still spreading, and specific drugs and treatments will need a lot. More time to develop and test.
Refer to Techcrunch
Source : Genk