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Emergency approval now “would change the way people view trials,” said Dr. Mila B. Ortigoza, an infectious disease specialist at NYU Langone Health who began a trial with colleagues at Montefiore Medical Center.
“We want to make sure that when we say it works, we are confident, with compelling evidence,” she said. “We take care of the lives of patients here.”
Unlike antimalarial drugs, plasma, used since the 1890s to treat infectious diseases, has attracted the attention of a highly skilled community of microbiologists and immunologists eager to prove its usefulness. The Mayo Clinic has already published tests on tens of thousands of patients in its expanded access program showing that plasma is safe.
The most recent batch of data from the program included more than 35,000 patients with Covid-19, many of whom were in intensive care and on ventilators, and suggested that plasma given within three days of a diagnosis reduced death rates. Calculated one month after infusions, the mortality rate for patients who received plasma within three days of diagnosis was lower (21.6%) than for those who received plasma later (26.7%).
But the study did not include a control group of patients given a placebo to compare with those given plasma, making it difficult for scientists to assess whether the treatment really worked. And given the limited supply of plasma, it’s unclear how realistic treating patients within three days of diagnosis would be.
Recruitment for the program has soared to more than 30 times higher than initially expected, making it difficult for scientists to recruit sick patients for randomized trials.
It “has swelled to a degree that you know is getting unmanageable,” Dr. Lane said.
FDA statisticians are currently reviewing the Mayo data to better understand what factors other than treatment may have influenced patient responses, such as better hospital care, Dr. Lane said.
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