Trials of Plasma From Recovered Covid-19 Patients Have Begun

And how'd it work? "The truth is, it's far too early," Musser says. "We, nationally, need to do controlled trials and understand, first and foremost, is this a safe therapeutic? There's lots of reasons to think it will be, but you never know."

That kind of straight therapeutic use of plasma, until now conducted on a patient-by-patient basis, will expand. Part of what the FDA approved was expanded access, so that places with a lot of blood donors could collect that plasma and send it to hospitals around the country-perhaps hundreds-where doctors want to use it on people who are just starting to decline from Covid-19, but before they need a ventilator. The FDA allowed Joyner's Mayo Clinic to hold a single authorization for all those hospitals' use. The American Red Cross, arguably the best organization in the country at collecting and moving blood around, will lead the logistics.

The actual data-collecting trials will be happening in parallel at Johns Hopkins and dozens of other hospitals across the country. Scientists want to know if plasma can improve the outcomes of people whose Covid-19 infections haven't gotten serious enough to require them to use a ventilator-if so, that will help stave off that resource-intensive outcome. Some will also give plasma to people who have been exposed to the virus but not yet infected. This form of post-exposure prophylaxis could be a literal lifesaver for health care workers exposed to high viral loads among infected patients, and perhaps working without complete personal protective equipment.

In addition to administering compassionate-use plasma, Houston Methodist will be one of the hospitals in the newly approved trial structure, as will the University of Wisconsin-Madison, where an anesthesiologist named William Hartman is coordinating the protocol. "We're trying to figure out how we could help the most critically ill patients, to see if we could figure out a way to alleviate their symptoms and shorten their course of infection," Hartman says. His hospital, too, has already put out a call for donors. "Since then, people have been just emailing me and calling the hospital," he says.

In fact, finding donors, making plasma and hyperimmune globulin out of their blood, and getting it to the hospitals that need it-all within the guidelines of informed consent from donors and recipients and keeping track of the resulting data-may well be the hardest part here. It requires the involvement of health care workers, bench researchers, and the people who run blood donation centers. And it all came together in less than a week. "We're talking to the top places in the country with a lot of expertise, people with a lot of depth," Joyner says, "and a lot of places where we have true content experts who can hopefully adapt these protocols, and who understand research and compliance."

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