Although the world—and, indeed, Colorado—is still clamoring for more robust supplies of ventilators, ICU beds, and protective gear to properly equip hospitals and health care workers, voices are now shifting to another critical issue: the need for treatments for COVID-19. President Trump has touted a pair of unproven anti-malaria drugs, and some researchers have posited that existing antivirals may work against the novel coronavirus. But there is another promising if unsubstantiated option that medical experts across the country are exploring: convalescent plasma, which refers to the practice of giving the antibody-rich blood product donated by COVID-19 survivors to critically ill COVID-19 patients.
In an attempt to help the sickest patients while simultaneously investigating the merits of convalescent plasma, nine local institutions banded together on March 27 to create the Colorado COVID-19 Convalescent Plasma Project Consortium, the first regional collaboration of its kind in the country. As one of the organizations leading the project, Kaiser Permanente’s cohort of specialists includes Dr. Rebecca Boxer, who spoke with 5280 to explain the group’s research as well as what we know—and don’t know—about this (hopefully) auspicious treatment.
5280: There are a lot of people and organizations involved in this research project—why so many?
Rebecca Boxer: It’s not a simple process to get this kind of initiative going. We needed hospitals, doctors, laboratories, blood banks, and testing capabilities lined up and coordinated so that a potential donor can navigate through the process, a patient can receive the plasma, and we can collect the data we need to study the treatment’s effectiveness.
It seems like the consortium got up and running with relative speed.
It was lightning-fast. Everyone who got involved has been so committed. They were clearing their calendars to make sure they could participate. There were a lot of late-night calls to get all of the right pieces in place.
Why is the medical community so intrigued with the idea of convalescent plasma?
Because there are no treatment options for COVID-19 right now. Convalescent plasma has been used before in other viral outbreaks, like Ebola and SARS. There’s been mixed evidence that it’s beneficial. More research is necessary. Plus, giving plasma is not unusual and the infrastructure is in place for donation, making it relatively easy to try as a treatment. The hypothesis is that antibodies in the blood of a survivor infused into a sick patient can help fight the infection and possibly reduce the severity of illness.
Does the work you’re doing qualify as a clinical trial?
No. This is not a clinical trial. Patients will not be randomized into a placebo group. This is a special type of research approach through the FDA that allows experimental treatments. We have to follow FDA guidelines for who can get the treatment.
So, who can receive convalescent plasma?
Right now, only the sickest patients can get it. Patients must be severely ill and intubated or their doctors must be strongly suspicious that they’re teetering on major decline and will need oxygenation support.
Has there been discussion that relegating the treatment to the most critically ill may skew the results of the research? Put another way: What if it works but not on patients who are too far into the disease?
That is something only the FDA can speak to, but what we know is this experimental therapy could potentially help the sickest patients who need care immediately. There are multiple randomized clinical trials happening outside of Colorado that are testing the plasma in less sick patients. Right now, the FDA is not allowing us to use plasma in the early stages of the disease. We hope that changes, and the FDA is changing and updating its regulations as we go through this pandemic.
Where does convalescent plasma come from?
Anyone who had a positive COVID-19 test—presumptive positives don’t count—who hasn’t had symptoms for 28 days, and who qualifies to donate blood can donate their plasma. Almost any blood bank can accommodate plasma donation. And we need donors because our biggest issue right now is not having enough units to give to patients. Plasma has to be matched by blood type, so we need all the blood types, especially the rarer ones.
Once the plasma is donated, is it tested for antibodies before it’s given to patients?
At this point, we don’t have antibody tests. We’re hoping to get access to quality tests at some point, but right now we are assuming if you tested positive that you have antibodies. We have, of course, had rich conversations about this assumption we’re making.
Is there any debate about who makes the best antibodies?
Oh, yes. We’ve debated this amongst ourselves and with the lab folks at Colorado State University. The questions with no answers yet are: Who is making the richest, most aggressive antibodies to COVID-19? Is it the people who got the sickest or the people who had mild symptoms? Right now, we are generally asking healthy people who had milder symptoms to donate plasma because we’d be hard-pressed to ask someone who’s just gotten out of the ICU to go give plasma.
How many patients have received the treatment so far?
I don’t have up-to-date numbers but probably just more than a dozen. We need more plasma to increase the infusions. I’m expecting to see an increase in units in the coming weeks, which will help hospitals secure the plasma they need. Right now there is some waiting going on. Hospitals are having to call around to multiple blood banks to find the plasma they need. Best-case scenario is that there are enough units that the wait time becomes short.
Has the treatment worked on the patients who’ve gotten it?
It’s too early to answer that question. But there is a national consortium through the Mayo Clinic, and they are collecting de-identified data from all over the country, including ours. Once they get enough data to analyze, we’ll have a better idea.
Why isn’t there enough plasma right now? Are people not interested in donating?
I’ve been blown away at how many people want to help. Coloradans have impressed me so much. It keeps me going to see the outpouring of interest and commitment to volunteer. It’s totally altruistic. It just takes time to find these people, ask them if they want to donate, screen them appropriately, and get them to the donation site. We’ve only been doing this for three weeks so we’re still getting systems going.
Besides treating COVID-19 patients right now, what is the ultimate goal of the consortium?
We need to advance the science while we’re helping patients. We need to be able to answer the important questions about whether this treatment works and how it works and who should get it and who makes the best antibodies and what makes a good antibody. We have so many experts that are working on these questions right now.
How is the consortium being funded?
Everyone involved—hospitals and doctors and researchers—is just doing it. There’s no real funding, although we are applying for some grants. They’re participating because it’s important, because it’s the right thing to do.
To learn more about the Colorado COVID-19 Convalescent Plasma Project Consortium and donating plasma, visit coloradocovidplasma.org.