The FDA has fast-tracked the use of convalescent plasma to treat critical coronavirus patients, and are working quickly toward convalescent plasma clinical trials from multiple investigators.
The treatment has only been approved on a case-by-case basis for use in patients with serious or immediately life-threatening COVID-19 infections through the process of single patient emergency Investigational New Drug Applications (eINDs) for Individual patients. This process allows the use of an investigational drug for the treatment of an individual patient by a licensed physician—upon FDA authorization.
While the FDA said it is still important to test the efficacy and safety of convalescent plasma, the health agency said it decided to facilitate access to the treatment “given the public health emergency that the expanding COVID-19 outbreak presents.”
In convalescent plasma treatment, the ill patient is transfused with the plasma of a surviving donor in the hopes that the donor’s antibodies will fight the virus. In the past, plasma has shown promise, being used most recently in 2014 during the Ebola outbreak in West Africa and earlier in 2002 during the SARS epidemic. The treatment dates back to more than 100 years ago when it was used during the 1918 flu pandemic. Convalescent plasma was also used to treat measles and other bacterial infectious before the advent of vaccines.
According to the Associated Press, beyond measuring if a convalescent plasma transfusion improves the chance of survival for critically ill patients, there is another way to test the treatment. If the FDA agrees, a second study would give antibody-rich plasma infusions to people at high-risk from repeated exposure to COVID-19, such as hospital workers or first responders. This group could also include nursing homes when a resident becomes ill.
Plasma from surviving patients is not the only antibody-approach scientists are taking in the fight against COVID-19. Regeneron Pharmaceuticals’ Kevzara (sarilumab) has entered a clinical program for patients hospitalized with severe COVID-19 infection. Kevzara is a fully-human monoclonal antibody that inhibits the interleukin-6 (IL-6) pathway by binding and blocking the IL-6 receptor. IL-6 may play a role in driving the overactive inflammatory response in the lungs of patients who are severely or critically ill with COVID-19.
The New York Blood Center will be the first to collect plasma from recovered COVID-19 patients. The center will collect the donations, process the plasma for infusion and maintain a bank for hospitals that need access for patients with life-threatening symptoms.
“We’re proud to partner with leading medical institutions from New York and beyond in developing this potential treatment, said Beth Shaz, chief medical and scientific officer at NYBC. “If this treatment proves to be effective, we are prepared to quickly scale our process and activate our network to serve hospitals nationwide.”