'10 months of work in less than a week': UW Health launching clinical trials of coronavirus treatment

Jeffrey Kluever, a 64-year-old from Wisconsin Lake Country, fought and beat COVID-19 and now hopes to donate his plasma for use in patients who are still sick with the disease.

His donation could go toward a clinical trial announced Monday, in which doctors at UW Health in Madison will begin using survivor plasma in an attempt to rescue the most severely ill.

The UW trial is part of a nationwide effort to launch clinical trials testing the effectiveness of the treatment.

"I've never experienced anything like it and fully understand the complete seriousness of the virus," Kluever said of COVID-19, which he contracted while on a ski trip in Austria in late February or early March. "I have huge respect for those taking appropriate actions so that other people don't have to get exposed."

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In the absence of a proven vaccine or treatment against the pandemic that has infected 1.3 million people around the world, killing more than 70,000, the U.S. Food and Drug Administration granted permission for hospitals to treat COVID-19 patients with survivor plasma on an experimental, compassionate basis.

The technique of using plasma from survivors to treat those still sick with the same disease goes back more than a century and has been used to quell outbreaks of measles, mumps and polio. It was also used with success against Spanish flu in 1918 and against another coronavirus, Severe Acute Respiratory Syndrome (SARS) in 2003.

Researchers believe plasma from recovered patients should be rich in virus-fighting antibodies. A patient receiving the plasma would immediately receive a large number of antibodies, rather than having to wait for their own immune system to generate them.

The infusion of plasma does carry potential side effects, including fever, allergic reaction and a small risk of infectious disease transmission. 

On Friday, the FDA gave researchers at Johns Hopkins University the go-ahead to launch a clinical trial administering survivor plasma to doctors, nurses and other first responders who are at high risk of exposure to the new virus.

Just one week ago UW Health and UW School of Medicine and Public Health joined Johns Hopkins in the National COVID-19 Convalescent Plasma Project, a grass-roots effort that involves 40 large hospitals and institutions, plus Amazon, Federal Express, the American Red Cross and the New York Blood Center.

More than 3,600 recovered COVID-19 patients have volunteered to donate their plasma since the project launched its website 11 days ago.

"Just sent contact info (to UW) for 24 potential donors in the Madison area," said Nigel Paneth, a professor of epidemiology and biostatistics at Michigan State University's College of Human Medicine who helps maintain the project's website and collects the names of donors who register.

William Hartman, an anesthesiologist at UW Health who will lead the effort in Madison, said that to prepare the clinical trial, he and a team of colleagues worked around the clock "to complete approximately 10 months of work in less than a week."

"Haven't slept much," he said. "We have a very motivated, very talented group of people who have a goal of bringing this treatment to our patients. They've been relentless in getting this set up."

In Madison, Exact Sciences has agreed to provide the COVID-19 tests required for all potential donors. The local Red Cross will be taking, processing and delivering the plasma donations to University Hospital.

Collecting enough survivor plasma is expected to be the greatest challenge to the research. Although more than 352,000 people across the U.S. have been infected with the virus, just 19,247 are considered to have recovered. 

To donate plasma for the project a recovered COVID-19 patient needs to have been symptom-free for 14 days. Potential donors will be tested three times.

The first test is to make sure they no longer have COVID-19. The second test is to ensure their plasma is not tainted by Hepatitis B, HIV or other viruses. Finally, potential donors are tested a third time to make sure they have sufficiently high levels of antibodies with which to fight the virus. 

At UW, Hartman said recovered COVID-19 patients can arrange to donate their plasma by calling 608-262-8300 or toll-free 833-306-0681 or emailing uwcovid19project@hslc.wisc.edu.

Kluever tested positive for COVID-19 on March 9, roughly a week before the national campaign to use survivor plasma.

He quarantined himself at home, treating his symptoms with cough syrup, Tylenol, water, Gatorade, Dove bars, popsicles, mandarin oranges called Cuties and especially Pedialyte, a drink recommended for flu patients to prevent dehydration.

Kluever said his fever peaked at 103 and there were nights when he would sweat through his pajamas several times.

"Physically, I was just completely drained," he said, adding that the first sign he was getting better was when his cough started to diminish.

"I'm committed to and looking forward to donating my plasma to be used by doctors on the front line to help others hopefully to make it through the COVID-19 journey," he said. 

Early signs have been promising for the plasma treatment.

Survivor plasma appeared effective in a small Chinese study of five COVID-19 patients, published recently in The Journal of The American Medical Association. The five patients, ranging in age from 36 to 65, were all on mechanical ventilation when they received the plasma. Four recovered from acute respiratory distress syndrome.

At 37 days following the plasma infusion, three of the five patients had been released from the hospital; the other two were in stable condition.  

Across the nation, the upcoming clinical trials will test at least three distinct groups of people: those who have been exposed to the virus that causes COVID-19 such as doctors, nurses, first responders and family caregivers; patients already hospitalized with the disease who have continued to grow sicker; and severely ill patients.