romaset / iStock / Getty Images Plus / via Getty Images
909158188
Platelet-Rich plasma preparation. Tube with blood in centrifuge. Background
When the National Institutes of Health announced in late April that a clinical trial of remdesivir had shown that the antiviral drug shortened the recovery process for patients with advanced COVID-19, it was the first bit of good news Dr. Sarah George had received since the global pandemic started. George, an associate professor of infectious diseases at Saint Louis University, was the principal investigator of the school’s remdesivir trial, treating COVID-19 patients at SSM Health Saint Louis University Hospital. SLU was one of 68 sites worldwide to participate in the NIH-sponsored trial.
“This is the first time we’ve had something that we knew actually did work,” George says. “There’s been a lot of small studies of X, Y, and Z, most of which didn’t really show much of an effect, or you couldn’t be sure it was real because it was so small and it wasn’t properly controlled. This is the first time we’ve had good solid data.”
Remdesivir, manufactured by Gilead Sciences, was shown to shorten recovery time for COVID-19 patients. Patients who received the drug recovered in 11 days; those who took a placebo recovered in 15. Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, announced that remdesivir is the new standard of care for patients hospitalized with COVID-19, and Gilead has now mobilized to manufacture the drug and expects to produce 1 million rounds by the end of this year. The Food and Drug Administration is also expected to issue an emergency use authorization for the drug.
The drug works, George explains, by directly attacking the novel coronavirus’ ability to replicate itself. The virus—just like every other virus—causes and spreads disease by way of the body’s own cells. “It basically hijacks them, takes them over, and turns them into virus factories,” George says. “So the virus reproduces itself and kills our body cells, and, of course, we’re spreading it to other people during that time.” Remdesivir, in essence, prevents the virus from making more of itself.
Although it’s good news, shortening recovery time from 15 days to 11 might seem a modest improvement when the virus has caused more than half a million deaths worldwide, more than 1,000 of them in Missouri. George has studied infectious diseases for almost 25 years. She’s seen other pandemics, including HIV, H1N1, Ebola, and Zika. None was as bad as this one. She calls COVID-19 the most intense pandemic situation she’s been in—as well as the most intense pandemic situation the world has been in since the 1918 flu. “We deal with viruses, common colds, and that kind of thing,” George says, “but this one, people can seem like they’re getting better and then they’ll just crash. Or they’ll seem to be fine and then they’re literally dying within hours. We still don’t understand that.”
“We’re not going to beat this until we get a vaccine,” she adds. That’s why additional trials and studies of treatments are necessary.
The centrifuge of the apheresis machine whirs to life, spinning a donor’s whole blood and separating plasma from red cells, white cells, and platelets. The plasma—convalescent plasma, specifically, donated by a patient who’s recovered from COVID-19—is the prize. The rest is returned to the donor. The collection bag fills with a golden liquid that, once the process is over, could be used to treat three COVID-19 patients. Containing the antibodies to SARS-CoV-2, the virus that causes COVID-19, it’s thought to help critically ill patients or those with a risk of becoming critically ill fight off the virus. In a U.S. Food and Drug Administration trial, Mercy is using it to treat patients with COVID-19; already, 80 recovered COVID-19 patients have donated. Still, Mercy health care providers aren’t sure whether it’s consistently helping sick patients; it hasn’t shown to be a safe and effective treatment.
Dr. Emily Schindler is the medical director of Mercy Blood Donor Services in St. Louis. “We’ve seen some people who’ve done [convalescent plasma therapy] and they’ve gotten better and left the hospital,” she says. “We’ve seen some people who’ve gotten it and it really hasn’t changed the course of their disease.” What’s vital now is information from the randomized controlled trial to help health care providers determine whether convalescent plasma therapy is affecting patients’ outcomes. “Hopefully then we’ll also get a little understanding in which patients will benefit the most from this treatment,” Schindler says.
When the FDA announced guidelines for convalescent plasma therapy—a treatment that was also used during the 2003 SARS and 2009 H1N1 pandemics and the 2012 MERS outbreak—Mercy was able to pivot quickly to get the program up and running. That’s because it has its own donor and processing facilities. Whereas other hospital systems rely on the Red Cross or Mississippi Valley Regional Blood Center for those services, Mercy could essentially do that work in house.
Mercy has performed 51 transfusions in COVID-19 patients. Following a Mayo Clinic protocol, Mercy gives a patient weighing less than 80 kilograms one unit of plasma and two units if the patient weighs 80 kilograms or more. The patient receives the unit in one day, and the treatment is not repeated.
Under FDA guidelines, patients who are severely ill or at risk of becoming severely ill with COVID-19 may undergo treatment—open-ended criteria, allowing health care professionals to use their judgment. “The main thing is, it’s an investigational product, and in the absence of proven treatments for this illness, we think it’s reasonable to make this available to our physicians and our patients so they can make an informed decision about what’s right for them,” Schindler says.
She admits that it’s stressful working under pressure, uncertain whether the therapy is successful. Schindler and her team must be honest with physicians and patients about what they know and what they don’t. “That’s really the best we can do, to just say, ‘Anything that might help, we’ll give you the full information, we’ll make it available for you, and as new information becomes available, we’ll share that,’” she says. She cites the pandemic’s ever-evolving nature and having to stay on top of new information as the greatest challenges.
Because donors in St. Louis have been so eager to help, Mercy hasn’t had to ask anyone to donate twice. Schindler says it has been rewarding to hear some of their stories. Mercy’s first convalescent plasma donor, Walter Lamkin, gave his plasma in part because he lost two friends to the virus.
“Some [donors] didn’t even know that they might have [COVID-19], but they were contacted by the health department as a contact of someone who was confirmed and they found out that way but never felt that sick,” Schindler says. “Other people spent weeks not feeling well. It’s a broad range of experiences, but they all were very honored and excited to be able to come in and give plasma. We’ve had a lot of interest in this program, and people want to know when they can come back and how often they can give. I do think in a time when we don’t know that much about treatments and there are a lot of things that are outside of our control, people are feeling empowered by being able to provide this plasma to help other patients.”
