Michigan hospitals can keep using convalescent plasma to treat certain COVID-19 patients - they’ll just have to keep jumping through certain hoops to do it. That's after the FDA has reportedly delayed authorizing the experimental treatment for “emergency use.”
That authorization would essentially allow doctors to use the treatment in COVID patients more widely, without having to meet certain requirements, like enrolling them in one of several ongoing clinical trials.
Anecdotally, convalescent plasma seems promising, because it's seen as relatively low risk.
And we know the treatment - giving plasma from a recovered patient to a sick one to help fight off infection - works for other diseases.
But there's still no conclusive data that this works for COVID-19. Still, some are optimistic about the early results.
“We treated one of our own physicians, a known hospitalist who has been with us for many years, with plasma,” says Dr. Indira Brar, a physician with Henry Ford Health System’s Divisions of Infectious Disease and Internal Medicine. “And he has since recovered and has been discharged from the hospital, and has done well.
“Since that day, we have treated over 150 with convalescent plasma. Almost all of these patients have been treated on a clinical trial. So either compassionate, choose the male clinical trial or our own Henry Ford are randomized clinical trials. All of these patients have been treated in those trials. Right. Anecdotally, all our patients have done well.”
Brar says they’re selecting patients for these trials that are already severely ill or particularly high risk - those who are on ventilators, are older, or have comorbidities. And despite her hopefulness about the treatment, she says she supports the FDA’s decision to hold off on expanding access.
“The FDA just put a hold on it because they thought that of all the trials we have so far, we don't have enough robust data to say that [it’s effective or not,]” she says. “Most of the clinical trials that have been reported so far are not randomized clinical trials. They don't really have a placebo arm. And because there are so many variables involved, they want to be sure that the effect that we are seeing in the decrease in mortality is really from the use of convalescent plasma. And not because of other variables. And that is why they're waiting for some of the randomized clinical trial data to be available.”
There are other ways patients can be treated with convalescent plasma, even outside of a clinical trial. That’s what’s happening to a select group of patients at the University of Michigan.
“From the start, we were part of the Mayo Clinic registry that has an ‘expanded access’ approval from FDA to help hospitals try this experimental option – they are collecting data from all the sites, but is not a formal clinical trial with comparison groups,” spokeswoman Kara Gavin said in an email Wednesday. “We continue to offer plasma to inpatients though we currently have a very low number of them.
Gavin says doctors at the University’s health system have also helped design a clinical trial, using plasma in the ER to treat COVID patients who are at higher risk. So far, they haven’t enrolled their own patients, but are coordinating the study nationally and working with several hospitals in Detroit.
