TOLEDO, Ohio — ProMedica is seeking federal approval to use blood plasma to treat critical coronavirus patients.
When someone gets coronavirus, they start to produce an anti-body response and for those people who recover, those antibodies remain in their blood and plasma. A survivor of COVID-19 can then donate what doctors call their 'convalescent plasma' to help severely ill patients.
According to the U.S. Food and Drug Administration's (FDA) website, the use of convalescent plasma has been studied in outbreaks of other respiratory infections, including the 2003 SARS-CoV-1 epidemic, the 2009-2010 H1N1 influenza virus pandemic, and the 2012 MERS-CoV epidemic.
Although promising, convalescent plasma has not yet been shown to be safe and effective as a treatment for COVID-19. Therefore, it is important to study the safety and efficacy of COVID-19 convalescent plasma in clinical trials.
The transfusion is an investigative treatment that ProMedica wants to use.
"We have to have donor plasma available. We have to have a recipient who qualifies for the severe disease. A patient or patient's surrogate willing to accept that transfusion and who understands the risks and benefits," said Dr. Brian Kaminski, ProMedica's Vice President of Quality and Patient Safety.
ProMedica applied for FDA-approval within the last week, but the hospital system also needs approval from its internal review board.
They would partner with the American Red Cross to receive convalescent blood donations.
"We'll pull our data with other organizations that are using it in order to help demonstrate what's its overall effectiveness is and what its utility will be for long-term treatment of coronavirus."
According to Kaminski, it's too soon to say when they'll be able to start their first case but he's hopeful the treatment will be successful.
The American Red Cross is currently accepting convalescent blood donations from recovered patients who must meet certain criteria.