One morning a few weeks ago, Rebecca Haley realized that her job had changed. Haley is the medical director for blood collection at Bloodworks Northwest, a nonprofit that serves 90 hospitals in the Pacific Northwest. But, Haley decided, regular blood and platelet donations weren’t the focus anymore. Like thousands of blood centers across the country, Bloodworks needed to collect something new: plasma from Covid-19 survivors.
Once someone is infected with the virus that causes Covid-19, their immune system begins to produce antibodies, specialized cell protectors that recognize the new coronavirus and fend it off. Once that person has recovered, their blood retains the antibodies. Transfusing those antibodies into a Covid-19 patient might be able to help them fend off their own infection, buying them time until their immune system starts producing its own antibodies. This treatment is known as convalescent plasma therapy, and it’s an old solution; doctors used it to help treat measles patients before a vaccine was developed and it has been used on Ebola, SARS, and MERS patients, as well as during the 1918 pandemic flu.
Scientists don’t know yet if this strategy works against Covid-19, but in early April the Food and Drug Administration approved two nationwide clinical trials that the agency would coordinate. As those trials get underway, blood centers around the country are mounting an unprecedented effort to collect the potentially life-saving substance—but they are also facing thorny logistical and ethical problems along the way.
“Nearly every blood center in the country has mobilized to help collect convalescent plasma,” says Kate Fry, CEO of America’s Blood Centers, a national network of 600 such centers. She says tens of thousands of people have reached out wanting to donate. “Thousands of units have already been shipped. We’re hoping for tens of thousands in the coming months,” she adds.
One of the upsides to trying convalescent plasma as a therapy is that it’s readily available from all those donors, and can be given to a patient as soon as 36 hours after being collected. But there are still many practical unknowns when it comes to using it for Covid-19. Should it be used only to help very sick patients, or should it be administered earlier in the course of the infection, before patients need to be put on a ventilator? How much do people need?
Researchers are running clinical trials to answer those questions, but the consensus right now is that, at the very least, convalescent plasma doesn’t seem to do much harm. With no proven treatments available for Covid-19, the FDA loosened restrictions on who can use the experimental therapy, allowing hospitals to join clinical trials or to use it in “compassionate use” cases, which are allowed for critically ill people when no other treatment options exist.
At Bloodworks Northwest, Haley says it was an easy decision to start collecting convalescent plasma. “The risk is low enough, the possibility of gain is high enough,” she says. Her center collected its first convalescent plasma donation on April 10. Since then, 700 people have put themselves on the donor list.
But that was the simple part. In the social distancing era, centers have had to retool their blood collection protocols to protect workers. At American Red Cross donation centers, that means checking donors’ temperatures before they enter the building, giving workers and donors masks, and keeping everyone six feet apart. It also means screening donors over the phone before they show up, says Erin Goodhue, the group’s executive medical director.
Blood centers already have the equipment they need to do the collection, but lots of internal processes have to be modified so that the staff can collect the plasma safely and make sure it gets sent to the right places. They need to have the right labels and billing codes, which help keep track of samples, even if the hospitals aren’t being charged. They need to update their computer systems to recognize convalescent plasma as a new product, and they have to make sure they can keep that convalescent plasma separated from regular plasma donations.
“This has just been an incredibly big lift,” says Goodhue of the push to get all their blood centers ready to collect convalescent plasma. “It’s coming up a little more slowly than we anticipated.”
Jed Gorlin, vice president at Innovative Blood Resources, a network of blood centers in several states including New York, Nebraska, and Minnesota, says it took three weeks just to get the new labels printed properly. Getting a root canal would be less painful, he says, and they’re all trying to be extra careful. "It's easy to mix stuff up," says Gorlin. "The amount of paranoid checking that happens with this process … it does add extra time."
But the biggest issue isn’t the computer systems or labels. As with so many other coronavirus stories, it all comes back to testing. “The testing issue is the largest problem,” says Claudia Cohn, chief medical officer for AABB, an international association of blood centers, hospitals, and transfusion services.
There is a lot of debate about the accuracy of the blood titre tests available now to determine whether a person’s blood contains SARS-CoV-2 antibodies. This has been a chief problem for efforts to run mass serosurveys determining what percentage of the population has been infected. Instead, in order to give plasma, potential donors must have a positive diagnostic swab test that proves they’ve been infected. (Unlike a blood antibody test, diagnostic tests use a fluid sample collected from a sick person’s nose or throat to search for the virus’s genetic material, a sign of a present infection.) Otherwise, doctors can’t be sure that plasma has the antibodies patients need.
But since many people never received a test, they are automatically ineligible. “Things are moving in the right direction,” says Cohn, referring to antibody tests that are making their way to the public. But, she says, “I’m sure that it’s frustrating for donors that want to help.”
Donors also have to be symptom-free for 28 days before they donate, to ensure the virus is out of their system. They also have to qualify as blood donors, which means they have to meet a number of requirements including not having hepatitis and not having traveled to a country with malaria for at least the past year. “It’s been difficult to get donors in who check all those boxes at this time,” says the Red Cross’s Goodhue, who expects to see a surge of donors in the coming weeks.
There’s no hard data on how many volunteers are being turned away right now, but Eduardo Nunes, vice president of Quality, Standards and Accreditation at AABB, says that anecdotal reports from centers show that lots of people are stepping forward but that only a “very small number of folks are making it all the way through the process.” In Kansas City, Jed Gorlin estimates that as many as half of convalescent plasma donors aren’t eligible.
And collection has been uneven across the country. In some places like New York City, where over 140,000 Covid-19 cases have been confirmed, there are simply more eligible donors than in places like Minnesota or Nebraska, where the wave of infections hasn’t yet hit. “We’re now starting to stock inventory,” says Gorlin, which will be distributed to new hot spots. “This is because New York had such an absurdly large number of cases. It’s not true in other parts of the country.”
In normal times, these centers have a system for distributing blood products to areas that need them. After serving their local needs, their staffers will send blood to affiliates in other cities. If there’s still surplus, they’ll distribute to other centers that are outside of their network. But right now, there just isn’t enough convalescent plasma to go around. “We have about 90 patients with Covid in our hospital right now,” says Cohn, who is also the director of the Blood Bank Laboratory at the University of Minnesota Medical School. “Only one donor has been collected in our region.”
Without enough convalescent plasma, and without clear guidelines about dosage or when the treatment is most effective, blood centers and hospitals are also being forced to make some challenging ethical decisions about who gets treated. The Mayo Clinic, which is organizing clinical trials for hospitals across the United States, has some established protocols for patients who want to receive plasma: They have to be over 18, to have a positive diagnosis for Covid-19, to be admitted to the hospital with a severe or life-threatening infection, and to consent to the treatment. But the clinic doesn’t provide many guidelines about who should get the plasma first and leaves it up to hospitals to get ahold of plasma from their local suppliers.
Initially, New York Blood Center rationed plasma, allowing hospitals to order only one unit of plasma for each patient. Gorlin also created an ethics panel that is in charge of making the rules for the Innovative Blood Resources centers in Kansas City and Minnesota so that it isn’t decided “by who yells at hospital services the most,” he says. The panel will only consider hospitals following the Mayo Clinic’s protocols, and it decides where to send plasma on a rotating basis so that smaller regional hospitals get a chance to use the therapy, as well as larger institutions.
If Bloodworks Northwest staffers have to choose among different hospitals that have requested plasma, they use a standard randomization process so the decision doesn’t come down to personal choice. The American Red Cross uses a first come, first served system.
At Claudia Cohn’s hospital in Minnesota, a group of doctors decides which patients will get plasma therapy based on early results from Mount Sinai Hospital’s trials. The panel doesn’t give plasma to patients already in the ICU, since some evidence indicates those patients are too sick to benefit from the extra antibodies. They also wait until a patient has been in the hospital longer than four days without improving—no sense wasting plasma on someone who is already mounting a strong immune response. “If they appear to be getting better on their own, leave them alone,” says Cohn. “If they get worse but aren’t in the ICU yet, that is the ideal patient population to prioritize.”
Those ethical questions about priorities will ease as more people are tested, recover, and donate their plasma to the national supply. Gorlin says he’s excited that so many people have volunteered to donate, many of whom have never given blood before. “It’s the only donation that comes out of your arm and not your wallet,” he says.
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