Northwest Indiana hospitals, Merrillville plasma donation center participating in studies for treating COVID-19 - June 9, 2020

Courtesy of Post-Tribune

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Two Northwest Indiana hospital systems and a Merrillville plasma donation center are involved in studies using plasma from recovered COVID-19 patients to treat those newly infected in hopes of helping them recover more quickly, as the number of cases nationwide continues to rise.

Franciscan Health and Community Healthcare System have both been participating in a national study spearheaded by the Mayo Clinic investigating the effectiveness of taking antibodies out of what is called convalescent plasma to treat those with COVID-19.

Meanwhile, Grifols Biomat, which has a plasma donation center in Merrillville, has been collecting convalescent plasma with the goal of using the antibodies from it to create a medicine to treat the virus.

“Convalescent plasma has been used since the 1800s to help people infected with different viruses and bacteria,” said Dr. Erica Kaufman West, an infectious disease specialist for Franciscan Health who has been involved in the study. She said convalescent plasma is regulated by the U.S. Food & Drug Administration.

Vlasta Hakes, spokeswoman for Grifols Biomat, said antibodies from the convalescent plasma has been used for treating rabies, tetanus and Ebola.

West said Franciscan Health has given the donated plasma to a handful of COVID-19 patients and has seen some positive results.

“They seemed to improve more quickly and did not get worse,” West said, but added the plasma didn’t help with some very sick patients. “They expired,” she said.

The Mayo Clinic stated earlier this month that researchers and collaborators found investigational convalescent plasma to be safe following transfusion in a diverse group of 20,000 patients, and noted a decline in mortality with the more rapid availability of the plasma. However, the study’s authors cautioned that this alone doesn’t provide evidence of the effectiveness of the treatment.

“Our efforts to understand convalescent plasma continue,” said Dr. Michael Joyner, principal investigator of the Mayo Clinic study and lead author of the article. “We’re optimistic but must remain objective as we assess increasing amounts of data.”

Dr. Dylan Slotar, an infectious disease specialist with Community Healthcare System, said several patients there received the convalescent plasma and the results are questionable.

“Was the plasma the cause for improvement or would the patients have improved on their own,” he said. “We need more data.”

Slotar noted that the Mayo Clinic enrolled about 20,000 patients nationwide in its study.

“We need that type of volume of patients to measure results scientifically,” Slotar said.

The Mayo Clinic researchers said that while the mortality rate decreased, the patients in the latter part of the study were less critically ill. They also said the decrease may be in part due to improved medical care based on increased knowledge during the pandemic and that more of the patients received the plasma earlier in their hospital treatment.

The Mayo Clinic’s safety report assessed the seven days following transfusion for hospitalized patients between April 3 and June 11 who were deemed at risk of progressing to a severe or life-threatening condition. Seven-day mortality rates declined to 8.6 % from 12% in a previous safety study of the first 5,000 transfused patients.

Serious adverse events continued to be less than 1%. The Mayo Clinic said convalescent plasma therapy is the only antibody-based therapy for COVID-19 at this time.

Hakes, of Grifols Biomat, said the company has been reaching out to potential plasma donors through word of mouth, marketing, the various Departments of Health in their locations and by collaborating with the U.S. Food and Drug Administration.

“We’re looking at collecting plasma from many donors to treat many patients,” Hakes said.

She said the company is working with the FDA to hopefully speed up the process, with the first batch of medicine expected to be ready for a clinical trial this summer.

To donate plasma, individuals must be 18 and older, have been diagnosed by a healthcare professional and need to be symptom-free for at least 14 days.

West and Hake said the plasma is screened for various other infections like HIV and hepatitis. Hake said it doesn’t have to be screened for COVID-19 since the virus isn’t transferred through plasma.

In addition to convalescent plasma therapy, researchers at the Mayo Clinic are studying many drugs and treatments for COVID-19, are researching the cause of the disease and how it affects the immune system, and are working on developing vaccines, the clinic stated on its web site.