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IOWA CITY - University of Iowa Health Care has started treating severe cases of COVID-19 with donated plasma from recovered patients as part of a new trial to determine whether the donor antibodies can help fight the disease.
So far, 11 recovered patients have donated plasma for the UIHC trial, and five patients have received the plasma via transfusion as part of their COVID-19 care at UI Hospitals and Clinics, officials announced Wednesday.
Even as the university ramps up its call for recovered patients willing to give plasma, many already have reached out to ask how they can help after UIHC Vice President for Medical Affairs Brooks Jackson earlier this month announced his campus was pursuing the 'convalescent plasma” approach.
In hopes of enrolling as many donors as possible - and eventually amassing enough plasma to help other hospitals treating COVID-19 patients - Jackson said his institution is offering antibody testing.
'We will also offer antibody testing for people who think they had COVID-19 based on their symptoms, but who didn't receive a COVID-19 test, to see if they would be eligible to donate plasma,” he said in a statement.
Presently, however, the university doesn't have capacity to do widespread antibody testing 'because we have not received the necessary supplies to do this on very many patients,” UIHC CEO Suresh Gunasekaran told The Gazette on Wednesday.
The hospital is placing orders and remains hopeful it will receive sufficient supplies and equipment over the next couple of weeks to ramp up antibody testing.
'But today, for plasma donations, we're focusing on patients we know have already had a laboratory-confirmed case of COVID-19,” Gunasekaran said.
The 'neutralizing antibodies” are key to the convalescent plasma approach, which other leading medical institutions are trying and testing across the country and around the world.
Gunasekaran on Wednesday said it's too soon to tell whether UIHC patients receiving the COVID-19 plasma are seeing any benefit.
But Vice President Jackson - who also is an expert in transfusion medicine - said plasma has previously been used to mitigate or prevent infection in other viral diseases.
'Our goal is to provide a treatment option, beyond the standard supportive care, for every one of our hospitalized patients with COVID-19,” Jackson said.
UIHC last week also joined an international clinical trial to evaluate the safety and efficacy of Remdesivir, deemed 'the most promising drug available to treat COVID-19.” The hospital - Iowa's only academic medical center - already has patients enrolled in that trial.
And the campus is engaged in other COVID-19 research focused on finding a cure, treatment or vaccine for the novel coronavirus, which causes COVID-19 and has been confirmed to have infected more than 2 million people worldwide.
UIHC has treated 65 COVID-19 inpatients, reporting 27 in its beds as of Tuesday - including one person under age 18.
The new UIHC plasma trial is enrolling donors who have recovered from COVID-19 and are willing to give plasma for other patients with severe coronavirus-caused illness.
Potential recipients must be hospitalized patients who've tested positive for COVID-19 and agree to receive the plasma transfusion, while also allowing a study team to follow and track their clinical progress.
Donors who've recovered from a positive COVID-19 diagnosis must be symptom-free for at least two weeks. Those who have recovered more recently also must test negative for the virus. Recovered COVID-19 patients who have been asymptomatic for 28 days don't need a negative test.
Donors must go through standard blood-donation screening as well, according to UIHC officials.
Once they're enrolled, donors give their plasma at the DeGowin Blood Center at UIHC - a process that involves a plasmapheresis machine that draws the blood; separates the plasma, which contains the antibodies; and returns the red blood cells back into the donor.
The process takes about 90 minutes.
Michael Knudson, UI pathology professor and co-director of the DeGowin Blood Center, and Patricia Winokur, executive dean of the UI Carver College of Medicine and a professor of internal medicine, led the way in getting the UI trial running so quickly.
'We are fortunate to have a world-class team of clinical researchers, transfusion specialists, pulmonologists, intensive care experts and hospitalists,” Jackson said. 'Their expertise and ability to work together is what allows us to bring these new treatment options to our patients.”
With more medical centers nationally employing the plasma approach, the U.S. Food and Drug Administration on Monday issued guidance for health care providers and investigators wanting to use and study COVID-19 plasma.
'Because COVID-19 convalescent plasma has not yet been approved for use by FDA, it is regulated as an investigational product,” according to the guidance, which noted convalescent plasma has been studied in other respiratory infection outbreaks like SARS in 2003, the H1N1 flu in 2009-10 and MERS in 2012.
'Although promising, convalescent plasma has not yet been shown to be safe and effective as a treatment for COVID-19,” according to the FDA. 'Therefore, it is important to study the safety and efficacy of COVID-19 convalescent plasma in clinical trials.”
Anyone interested in giving plasma or getting more information about the UIHC trial can contact PathologyCP@healthcare.uiowa.edu, or call (319) 678-7922.
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