The US Food and Drug Administration (FDA) has granted emergency approval to therapy for COVID-19 using plasma from recovered people.
When a person becomes ill with COVID-19, their immune system, the body’s defense mechanism, generates antibodies that fight the infection.
These antibodies literally float in the blood plasma, which is the fluid where the blood cells are.
Doctors can separate the plasma from the blood, and isolate the antibodies. This derivative of plasma or convalescent plasma, as it is called, and the antibodies they contain, helps the body of an infected person fight the disease until it generates its own antibodies.
Although approval was now granted, treatments were already being carried out under what is known as “compassionate use”, which occurs when it is empirically seen, in hospitals, that a treatment works even if it has not gone through all the approval channels of the process scientific.
In May, the Mayo Clinic published a study of 20,000 demographically diverse COVID patients (about 40% were women, 20% were African American, about 35% were Latino, and 5% were Asian). This intervention demonstrated that treatment with plasma from recovered persons reduced the number of deaths and reduced symptoms.
“Our efforts to understand convalescent plasma continue,” said Michael Joyner, lead author of the paper at launch. “We are optimistic, but we must stay objective as we evaluate increasing amounts of data.”
So far, no relevant side effects have been reported during the use of convalescent plasma therapy in COVID patients. But there is still a long research road to go.
Earlier in April, FDA commissioner Stephen Hahn had said that recovered people should donate their plasma. Now the federal entity approved the treatment, however, Dr. Francis Collins, director of the National Institutes of Health, and Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, expressed concern about the emergency approval.
Both scientists say that the scientific evidence on the use of convalescent plasma to treat COVID patients is still weak. The debate in the community is how much evidence is needed to legitimize a treatment.
What is an emergency approval?
Typically, the approval process for a drug is a slow process, which in certain cases can take years. The potential drug is tested in clinical studies that have three phases: from use and safety in animals to thousands of humans.
However, when there is a public health emergency, such as the COVID-19 pandemic that we are experiencing, the mechanisms accelerate and what is known as the “fast track” is put into operation.
If a new drug is seen in hospitals to be working, it is given emergency approval, so that more people can benefit from its use.
- The best way to prevent coronavirus
This is what just happened with the plasma therapy of recovered people.
Desperate search for treatments
Thousands of laboratories around the world are racing against time to discover drugs that can alleviate the COVID-19 symptoms, the disease that can develop when contracting the new coronavirus.
Of course, a vaccine is the great goal, but having drugs and therapies that improve symptoms and reduce the time in which the virus is eliminated from the body would mark a great victory in the war against this germ, which the planet knew for the first time in December 2019.
Plasma treatments have been used with some success to treat measles, mumps, and flu. The idea is to use immune cells taken from the blood of people who have recovered from COVID-19 and inject them into infected people, giving them passive immunity to the disease, which could at least minimize some of its most serious symptoms. And cheat death.
In late March, the New York Blood Center became the first center in the United States to collect blood from people recovered from COVID-19.
- This is a COVID-proof home
Doctors from New York’s Mount Sinai Hospital Health System are now sending recovered patients (and willing to do so) to this blood center, which collects and processes plasma and provides the antibody-rich therapy to hospitals to treat others. COVID-19 patients.
In another vein, in early April, an international group of scientists reported promising results for treating COVID-19 with a drug called remdesivir, a drug that was never formally approved but was investigated for the treatment of Ebola.
In the study he published New England Journal of Medicine, scientists said tests showed that the use of this drug had helped 68% of COVID-19 patients overcome respiratory problems.
The controversial hydroxychloroquine drug, which is used to treat malaria and certain autoimmune conditions, was presented as another potential candidate, but it proved to have fierce side effects.
Mice and people
Highly genetically engineered companies such as Regeneron, in New York, are searching among millions of antibodies generated by mice infected with SARS-COV-2 (the new coronavirus) with the goal of finding the one that is most effective in neutralizing the coronavirus.
At GigaGen in California, they have identified the correct antibodies in recovered COVID-19 patients and hope this will serve as a basis for developing an antibody-based coronavirus therapy.
Along the same lines, researchers at Rockefeller University are analyzing a protein discovered in 2017, called LY6E, as a potential candidate to block the reproduction of the coronavirus once it enters an organism.
Other scientific groups are looking at the use of another old friend, nitrous (or nitric) oxide, which is often used to relax blood vessels and open blood flow in hospitalized patients who have trouble breathing, including with fans .
At Belllerophon Therapeutics they are developing the idea of Professor Roger Alvarez, from the University of Miami, who thought about the use of this gas for respiratory and lung problems related to COVID-19.
Elli Lilly and Novartis Labs are investigating the use of anticancer drugs and anti-inflammatory drugs to treat COVID-19 patients. These drugs “exaggerate” the reaction of the immune system, to act against the “external agent”, in this case the coronavirus.
At Columbia University, an AIDS legend and father of antiretroviral therapies, Dr. David Ho, along with his team, is analyzing a “library” of more than 4,700 drugs.
It is a file of drugs, approved and not, which, according to Ho, can be used to discover potential drugs for this pandemic or the next (scientists say there could be a second wave of coronavirus outbreaks next winter).
Or eventually other new germs that challenge Humanity in the future.
Sources: NIH, NIAID, CDC, Mayo Clinic
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