In the rush to find solutions to the coronavirus pandemic, researchers at Mount Sinai Health System have focused on a national plasma antibody project in hopes of saving lives immediately.

Other research such as drug trials are also underway at Mount Sinai, but hospital researchers have shifted the experimental plasma antibody project into high gear — in part because there's a "sweet spot" when recovered COVID-19 patients' plasma samples are richest in antibodies, said one research official.

"Our priority push right now is for the convalescent plasma, as we feel as though that could hit the most number of eligible patients," Michele Cohen, the administrative director of the clinical trials office, Department of Medicine at Mount Sinai Health System, told Gothamist on Thursday.

"We are ramping up. We are using medical students to help with this process and staff have been redeployed in many different capacities to make sure that we are all working together as quickly as we can to find the best treatment and the best options for our patients," she added.

Mount Sinai is one of the 34 institutions participating in the National COVID-19 Convalescent Plasma Project that is trying to gather the antibody-rich plasma of people who have recovered from coronavirus.

The plasma will then be transfused to seriously ill patients — this process was used "successfully in China, according to a state-owned organization, which reported that some patients improved within 24 hours, with reduced inflammation and viral loads, and better oxygen levels in the blood," Mount Sinai noted on its website.
"Your immune system may now be producing antibodies to protect you from becoming infected again with coronavirus. If so, your plasma may be rich in these antibodies and be helpful in the treatment or prevention of COVID-19 disease in others. Donated plasma could be used right now, for compassionate treatment, even before we have scientific trials, or as part of a trial to determine definitively if this treatment works," the plasma project website says.

Faced with a national blood shortage, the FDA announced Thursday it is immediately changing its guidelines on who can donate blood. The agency is shortening the blood donation waiting period from 12 months to three months for people who had engaged in "exchanging sex for money or drugs, for engaging in non-prescription injection drug use; or, for a male donor, having sex with another man." These newly qualified populations can donate after a three-month waiting period if eligible, the FDA said. The larger donor pool will "hopefully" also increase the pool of potential plasma donors, Cohen said.

Since the FDA approved the convalescent plasma program on March 24th as an emergency individual treatment, Mount Sinai has been inundated with people offering to donate plasma. Cohen said more than 7,000 people had submitted an application and 1,500 of those were in the process of being approved for donation.

"That is quite robust," she said of the response — but noted the influx of eager participants also meant additional work for the Mount Sinai team. Part of the urgency is that the hospital staff have to process applications from potential donors who are facing a ticking clock of when their plasma is most effective, which the FDA has said is sometime between two to four weeks after full recovery.

"For everything with COVID-19, we're still learning a lot of information and how to process things. However, there seems to be a titer level which is how your immune system mounts a response. And that titer level must be at a certain level to make the plasma donation valid," Cohen said.

There's also criteria for who can receive the plasma transfusions — patients need to "have laboratory confirmed COVID-19" that's severe or immediately life-threatening, the FDA said. The patients must also be hospitalized, Cohen said, and capable of providing informed consent.

There have been 13 patients approved to receive the plasma transfusions so far at Mount Sinai, with the first transfusion completed Saturday, she said. Each patient will receive two bags that contain about two pints of plasma. Donors can give to one or two patients at most — so researchers are hoping to recruit many more donors.

One limiting factor to finding more donors is the lack of testing — only people who were confirmed to have coronavirus are eligible to donate, though Cohen said that guideline may also evolve over time.

"I think that the rule and the parameters for everything with COVID-19 changes day to day," she said. "So today, that's where we are in terms of the testing, and that might not be where we are tomorrow."

To find out if you are eligible to donate plasma, visit this website.

With Katherine Fung / WNYC