US Food and Drug Administration department has now announced the approval for the nationwide trials of two treatment options for COVID-19. The COVID-19 has been a disastrous pandemic that has affected millions of people worldwide, leaving thousands of people dead. It is because of this reason that the use of these two treatments is now approved for hundreds of patients lying down in the hospital beds.
CONVALESCENT PLASMA AND HYPERIMMUNE GLOBULIN:
The potential, therapeutic agents, i.e., hyperimmune globulin and convalescent plasma, are both extracted from the blood of the recovered COVID-19 patients. These are the antibodies that are present in the human body and produced by the immune system to fight against viruses and other bacterial agents. Stephen Hann (FDA commissioner) said that it is one of the critical areas of research where the use of these products is to be made from the blood of the recovered patients to treat COVID-19 potentially. He further says that the FDA has played an essential role in organizing a partnership between the academic institutions, industry along with government agencies to simplify the expanded access to convalescent plasma. It is contemplated as one of the exceptional examples of how we come along and take swift actions to help Americans during such a crisis.
SMALL AND PRELIMINARY TRIALS FOR FINDING OUT EFFECTIVENESS OF THE DISEASE:
Until now, physicians have been using a combination of pain-killers and antiviral drugs for people infected with the coronavirus. It is because there is still no specific vaccine or medicine for viral disease. The possibility of using hyperimmune globulin and convalescent plasma seems a hopeful one that is to be utilized as a therapeutic agent and is under the testing process. Other drugs are also under trial, i.e., Ebola virus drug Remdesivir and immunosuppressant/ antimalarial drug Hydroxychloroquine or chloroquine. Using the blood products of the recovered patients against the deadly disease has been an old approach that has been under trial and studies for a long time now and has shown promising results. The healthcare workers have been finding it successful against MERS, Ebola, and SARS. However, a couple of small and preliminary studies have been undergoing the trial for convalescent plasma and show effective results.
RIGOROUS TESTING TO FIND OUT THE EFFECTIVENESS OF CONVALESCENT PLASMA:
The researchers have undergone thorough testing for the effectiveness of this therapeutic agent. At the same time, the FDA has announced the use of convalescent plasma for COVID-19 patients. Michael Joyner, who is a physiologist at Mayo Clinic, says that it seems like ancient history, but there have been several uses of it for now. He facilitates a 40-center trial for such new therapies, which are currently approved by the FDA along with co-researchers from John Hopkins. Joyner himself adores this treatment option because he got himself treated by gamma globulin as a preventive option against Hepatitis B during the 1980s. Some hospitals nationwide are already injecting this agent against coronavirus as compassionate use even if the FDA did not approve it. During compassionate use, when the patients have no other choice, unapproved drugs can be used for treatment. Houston Methodist Hospital has started using compassionate-use transfusions of convalescent plasma derived from the patients who appeared positive and have no symptoms now after 14 days. James Musser, the Chair of Genome Medicine and Pathology who works at the same hospital, agreed with Arturo Casadevall (immunologist at John Hopkins), he has transfused four of his patients with the convalescent plasma. He suspects to do the same with the fifth patient who will receive plasma today. When Musser was asked about its mode of actions, he explains that it is too early to talk about it. He adds that there is a need for controlled trials nationwide first and foremost. When asked whether it is safe and therapeutic, he said that there are many reasons to believe it is, but we do not know about it yet.
WHAT CAN BE DONE, ONCE PLASMA IS DERIVED FROM THE COVID-19 SURVIVORS?
This therapeutic agent is now approved by the FDA, which means we need excess blood donors from the survivors of the disease who have antibodies produced in their bodies. Other than this therapeutic agent to be collected in hundreds, hospitals require ventilators that we are looking at. FDA has now allowed Joyner’s Mayo Clinic to work as single authorization for all hospitals. American Red Cross is held for organizing and collecting blood nationwide for logistics. John Hopkins, on the other hand, will be responsible for data collecting trials along with other hospitals nationwide. Researchers and scientists believe that the use of plasma might help the patients to avoid any need for a ventilator. They further understand that healthcare professionals who are exposed to the disease should be prophylactically injected with convalescent plasma. Houston Methodist and the University of Wisconsin-Madison are working hard to figure out the critically ill patients who need help and figure out how to alleviate their symptoms by shortening the course of the disease. He has asked donors to reach the hospital as soon as possible.
The course of recipient and donor’s plasma, their consent, the derivation of hyper-immune globulin and plasma formation, all needs a proper track and appropriate involvement of healthcare professionals in all fields. Joyner believes that we need to compile all the facts within a week and try to work it out with extreme expertise while genuinely following the protocols.