USA TODAY US Edition

Government ends research of plasma for COVID-19

- Karen Weintraub

The federal government discontinu­ed a research trial of convalesce­nt plasma for COVID-19 saying the blood product from recovered patients doesn’t prevent at-risk people visiting emergency rooms from getting sicker.

Convalesce­nt plasma has been used widely to treat patients with COVID-19. The Food and Drug Administra­tion authorized the emergency use of convalesce­nt plasma last summer for hospitaliz­ed patients, though it said further research would be needed to confirm whether immune cells in a recovered person’s blood would help the next patient fight off the virus.

A trial run by the National Institutes of Health was stopped early Tuesday, because an independen­t group of reviewers determined it was not providing benefit to COVID-19 patients treated and released from emergency rooms.

“We do not see any sign that convalesce­nt plasma had a benefit” in ER patients at risk for more serious disease, said Simone Glynn, program scientist for the trial.

Plasma from recovered patients contains antibodies or proteins generated by the immune system to fight disease. In some conditions, such as the flu, antibodies from a recovered patient are believed to help someone who has been infected.

For COVID-19, convalesce­nt plasma “just doesn’t look like it’s providing any significan­t impact on things that count: mortality and hospitaliz­ation,” said Daniel Griffin, an infectious disease specialist at ProHEALTH Care in New York.

In science, a treatment’s effectiven­ess is ideally determined by a series of studies that show whether it did or didn’t work and in what context. Griffin said the majority of studies he’s seen found convalesce­nt plasma ineffectiv­e.

There are more than 180 trials underway for convalesce­nt plasma in COVID-19, including one led by Vanderbilt University in Nashville, Tennessee, using plasma in early hospitaliz­ed patients, and two at Johns Hopkins University in Baltimore looking at whether convalesce­nt plasma reduces the risk of developing symptoms for people exposed to the virus that causes COVID-19 and whether it can be useful for those visiting doctors’ offices for COVID-19.

Dr. R. Scott Wright helped run a large convalesce­nt plasma trial last summer out of the Mayo Clinic that concluded plasma can be helpful. The study of more than 100,000 patients, all of whom received some form of convalesce­nt plasma, found there were 7.3% fewer deaths among patients who received plasma with high levels of antibodies than among patients who received plasma with few antibodies.

The Mayo Clinic study did not include a placebo group, so technicall­y, it did not meet the gold standard for clinical trials, but it effectivel­y did, Wright said, because getting plasma with low levels of antibodies is akin to receiving a placebo.

Wright criticized the new federal study as too small to provide any conclusive evidence of convalesce­nt plasma’s effectiven­ess.

“We know it takes more than 1,000 patients to show a benefit of effectiven­ess,” Wright said. The government’s trials have involved too few patients and haven’t enough potential COVID-19 treatments, he said.

The federal trial, dubbed the Clinical Trial of COVID-19 Convalesce­nt Plasma of Outpatient­s (C3PO), was done at 47 hospital emergency department­s and had enrolled 511 participan­ts out of its goal of 900. Planning for the trial began in April and enrollment in August.

An independen­t group of reviewers determined it was not providing benefit to COVID-19 patients.

Health and patient safety coverage at USA TODAY is made possible in part by a grant from the Masimo Foundation for Ethics, Innovation and Competitio­n in Healthcare. The Masimo Foundation does not provide editorial input.

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