As social distancing buys infrastructure time to prepare for the wave of the pandemic, medical experts at the Mayo Clinic are developing a treatment for Covid-19 using convalescent plasma.
The treatment involves infusing patients with plasma from those who have recovered from Covid-19, which would provide the antibodies necessary for fighting the infection. Plasma donors must have recovered from Covid-19, have tested negative for it, and be otherwise healthy.
"Our goal is to see if we can help people who are sick from going to the ICU, and then help people who are in the ICU get out of it a little bit faster," said Michael Joyner, principal investigator of the Mayo’s Convalescent Plasma Expanded Access Program.
The use of plasma as a treatment option for outbreaks dates back to the 1890s, according to Mayo Clinic. Small clinical studies found that convalescent plasma helped against other coronaviruses, but not against Ebola, which is another coronavirus.
“The big bottleneck is identifying potential donors, carefully screening donors, getting those donors who are eligible to a blood collection facility,” Joyner said. “So there’s a number of logistical steps that have to be lined up so that we can make this happen.”
While there is plenty of interest in the program, it will take until about the middle or end of April to really have a substantial number of donors, he said. This is due to needing to have gone so long without symptoms, or having tested negative for the disease.
The recently assigned expanded access protocol from the U.S. Food and Drug Administration not only facilitates the treatment of patients, but allows for data analytics in real time, Joyner said. He hopes this sets the stage for randomized clinical trials in the future.
“This isn’t going to go away magically any time soon, and after it is suppressed there are still going to sporadic outbreaks and cases until there’s a vaccine,” he said.
The treatment is for those who are hospitalized with severe or life-threatening cases of Covid-19, or for those with a high risk of progressing to that point. The FDA announced the coordination of blood therapy efforts of 40 institutions on Friday, including its designation of Mayo as the lead institution.
“The FDA is launching a new national effort to bring blood-related therapies for Covid-19 to market as fast as possible,” Alex Azar, the Health and Human Services secretary, said in a press release.
The coordination will support the collection of data, develop a protocol to refine the therapy, and determine if the treatment is safe and effective, said Greg Poland, a Mayo Clinic infectious diseases expert and head of the Mayo Clinic’s Vaccine Research Group. .
“Right now we have no other therapies other than supportive care,” he said. “At some point we’ll have a vaccine. And so what do you use before you have those things in critically ill patients? I think plasma therapy has the strongest chance of being immediately helpful.”
And with the plasma donations needing to come from very specific people, it will take some time to ramp things up, Poland said.
“I think the people of Minnesota should be proud that this is being coordinated and is federally designated here at the Mayo Clinic,” Poland said.