ROCHESTER, Minn. — Ten days after granting emergency approval for compassionate use of the time-tested antiviral treatment known as convalescent plasma transfusion therapy, the FDA has designated Mayo Clinic as the lead institution for coordinating investigational use of the promising intervention in the care of patients with severe or life-threatening COVID-19.
The move effectively places the state's largest private employer at the forefront of treatment for the illness.
"We are pleased to work with our colleagues and the nation to fight this pandemic every way we can as part of Mayo's patient-focused mission," said Dr. Michael Joyner in a statement. "We believe this program, in extending access to this investigational treatment, is a hopeful therapeutic option. We anticipate a trickle of convalescent plasma for therapy will begin next week, with more available in the following weeks. We also will collect data so we can understand how best to use plasma to treat COVID-19."
Widely considered the strongest tool on the near horizon for reversing illness in an expected crush of hospitalized patients suffering from COVID-19 within the health care system in coming weeks, convalescent plasma has quickly acquired multiple institutional partners, high-profile financial support, the participation of the American Red Cross, online retailer Amazon, the nation's blood banking care association, and a steady march of preliminary papers suggesting its safety and effectiveness.
Earlier this week, Houston Methodist Hospital reported the first American to have been treated with antbody-rich plasma harvested from persons previously stricken with coronavirus and has now treated two persons.
Research on 19 patients from investigators in Wuhan, China, which was released on March 25 and which is prior to peer review revealed that the treatment was well-tolerated in all patients, and appeared to reduce viral load to undetectable levels after transfusion in seven patients. A subsequent study of five patients from Shenzhen, China, and published in JAMA found that patients all came of ventilators after the treatment, albeit at different rates. The FDA designation places Mayo in the position of more rigorously investigating these findings, with a larger pool of patients, and positioned at the center with Johns Hopkins of the roll-out.
It's a project that began in earnest on March 21 with a 100-physician conference call organized by Joyner, an emergency meeting in response to an idea first put forth by the Johns Hopkins Bloomberg School of Public Health microbiologist Dr. Arturo Casadevall. It unites a broad coalition of Mayo Clinic specialists and a host of clinicians from 40 institutions in 17 states.
In a critical stroke of good timing, and one that might have played a role in the FDA decision, the designation comes just as Mayo Clinic Laboratories has announced it will release a blood test capable of determining if patients have coronavirus antibodies, a necessary first step in identifying who can donate their blood to potentially help others come off ventilators.
"We will be testing convalescent plasma donors using this test, definitely," says Dr. Elitza Theel, associate professor of laboratory medicine and pathology at Mayo Clinic. "We are still working with infectious disease colleagues to really define the appropriate use of these tests, because right now we have limited kit availability. So we want to make sure the right individuals are being tested at the right time."
If the program is successful in ramping up capacity to treat coronavirus patients statewide, it will require a substantial administrative infrastructure to coordinate the transfer of plasma from recovered coronavirus patients and distribute it widely. Asked if the state health department might play a role in helping to centralize or facilitate the rollout of this effort health officials replied in the affirmative.
"The health care system in Minnesota, for this response, is connected together through 8 regional health care coalitions and a coordinating task force of which MDH is a part," said Doug Schultz of the Minnesota Department of Health. "In past emergencies, such as the H1N1 pandemic, when health care systems needed MDH to act as a central facilitator or broker, such as in sharing of vaccine resources, we have fulfilled that role. We envision doing that again if asked to do so."
Physicians treating hospitalized patients with COVID-19 can register their patients' information at uscovidplasma.org.
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Minnesota Department of Health COVID-19 hotline: 651-201-3920.
MDH COVID-19 website: Coronavirus Disease (COVID-19) website.