A broad alliance of Mayo Clinic research specialists are partnering in an expedited, multi-center coalition of regulatory, scientific and commercial partners — including the online retailer Amazon — in a race against the clock to deliver a promising treatment for coronavirus to the nation's hospitals.
With vaccines 18 months away at best, and with coronavirus-targeting antivirals travelling in a clinical trial pipeline that could extend into next year, the results of the so-called convalescent plasma treatment for coronavirus could potentially put a critical bridge therapy into healthcare workers' hands in one month's time.
"There's many if's here," said Mayo Clinic research physiologist and project participant Dr. Michael Joyner. "There's many potential barriers. There's many things that could go wrong or could delay it. But hopefully we would be in a position in a month or so to deliver it to people who can benefit from it."
The project is spearheaded by Dr. Arturo Casadevall, a professor of molecular immunology at the Bloomberg School of Public Health at Johns Hopkins University in Baltimore. "Deployment of this option requires no research or development," Casadevall has recently stated. "It could be deployed within a couple of weeks since it relies on standard blood-banking practices."
"Arturo came up with the idea that as we get more and more people recovered from COVID-19, two or three weeks after they are asymptomatic they are going to have very high levels of antibodies against COVID-19 in their blood or plasma," Joyner said. "We want to collect some of that plasma and use it either for post-exposure prophylaxis (prevention), or to treat people who are sick early in their hospitalization, with the goal of shortening the duration of the disease and keeping them out of the ICU, thus decompressing the healthcare system."
"If we can get these dominoes lined up, and they fall correctly," Joyner said, "as large numbers of people start to recover in the United States, we can harvest plasma from them and give it to patients safely in a way that shortens the course of their disease, or prevents them from getting it in the first place if they've been exposed."
Convalescent plasma is a time-tested pathogen treatment first used against diphtheria in the late 19th century, later against the 1918 influenza, measles, mumps, chickenpox, MERS, SARS, H1N1 and Ebola. Though the immunology of convalescent plasma is well known, its effectiveness with coronavirus is still being determined.
It's limitations involve a small risk of enhanced infection and the necessity of carefully timing the treatment, but otherwise come down to a modest handful of safety issues that apply to the use of all blood products in transfusion medicine, a category of care that has been well-tolerated for decades.
While the biology and safety of passive immunity is well-known, a nation-wide roll out of coronavirus antibody serum poses an administrative and public health challenge like no other. Following an expedited approval of the project via the investigational new drug pathway at the FDA, the campaign will require the wide-scale identification of persons with antibodies for coronavirus, followed by a uniform, population-scaled screening process of potential donors.
That's just for the gathering of plasma. Quickly delivering it to the nation's hospitals will require another set of Herculean logistical and clinical challenges, including the need to quickly communicate to a disparate sea of clinicians an entirely-new protocol for delivering the antibody-containing transfusions. Joyner says this is an area where an infrastructure has already been created, thanks to well-developed supply-chains behind the nation's commercial plasma centers.
"Because of the great skill and capacity of our blood banks across the country, we know how to obtain plasma, prepare it and give it safely," Joyner says. "So if we can give patients plasma that's rich in these antibodies, that can help us hold us off the illness until the biotech cavalry arrives with vaccine and medicines."
Reached for a midday call last week during a break in helping to write the study design — "this isn't exactly my wheelhouse but it's close enough that I figured I could take a stab at it" — Joyner said his lab had cleared out and begun working from home out of the need for social distancing. "It's like Christmas day, here," he said of his empty surroundings, inactivity that belied the broad and frenetic institutional effort to move the therapy through review and into practice.
Others within Mayo working on the project include an interdisciplinary team of immunology, transfusion medicine, pulmonology, radiology, infectious disease and IRB-affiliated participants, a list Joyner said included Drs. Elitza Theel, Camille van Buskirk, Andrew Badley, Jeff Winters, Jim Stubbs, Philippe Bauer, Jack O’Horo, Rickey Carter, numerous fellows, and the clinic's institutional review board staff.
Nationally, the project is utilizing the expertise of participants from 20 institutions, a short list of the nation's research braintrust that includes Johns Hopkins, Washington University of St. Louis, Alfred Einstein University, Duke, the University of Pittsburgh, Michigan State, Stanford and the University of California system. "This thing has taken off like wildfire," Joyner said. "The scientific community has really rallied around Arturo's ideas, and see this as where we can help the fastest."
"What's been amazing is, we had this large conference call yesterday with people that are very well known, and a lot of those people have pretty healthy egos — 'I discovered this or I did that.' We had none of that. Everybody is just trying to focus on what's in front of them. We've got people who are the top virologists and experts in transfusion medicine from across the country and all over the world involved. We have commercial partners who are excellent at collecting plasma at sites all over the county reaching out to us."
Even the world's online retailer is said to be chipping in, by building a website to centralize the initiative's internal and external communications. As of press time, Amazon had not responded to a request to clarify their participation. Currently the IRB committee at Johns Hopkins is studying a plan to test coronavirus plasma for preventive use, while Mayo is reviewing a treatment protocol for hospitalized patients who have yet to reach a severe state of sickness.
At the time of the call last week, Joyner had already participated in two nationwide group conference calls, had two more scheduled in the coming days, and was midway through a 20-hour workday. "I took my first call at 4:37 this morning from a colleague at Einstein in New York," he said before brushing aside the topic. "I'll be getting emails about this until midnight but I'm getting some rest. The people on the front lines are the clinicians — the nurses, the first responders, the people in the ICU."
How does it feel to fight the worst outbreak in modern times with an old-fashioned method?
"Washing of hands is an old fashioned method too," he said.
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