An approval for emergency services would now “change the way people view tears,” 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 unintentional evidence,” she said. “We are dealing here with the lives of patients.”
Unlike malaria drugs, plasma, which has been used since the 1890s to treat infectious diseases, deserves the attention of a highly recognized community of microbiologists and immunologists who want to prove its usefulness. The Mayo Clinic has already published analysis on tens of thousands of patients in its extensive access program that shows that plasma is safe.
The most recent batch of data from the program included more than 35,000 Covid-19 patients, many of them in intensive care and on ventilators, and suggested that plasma administered within three days of diagnosis reduced mortality rates. When calculated one month after the infections, the mortality of patients who received plasma within three days after diagnosis was lower (21.6 percent) than it was for those who later received plasma (26.7 percent).
But the study did not have a control group of patients who received a placebo to compare with those who received plasma, making it difficult for scientists to assess whether the treatment really worked. And given the limited supply of plasma, it is not clear how realistic treatment of patients would be within three days of diagnosis.
Enrollment in the program has increased to more than 30 times as high as originally expected, complicating the ability of scientists to recruit sick patients to randomized trials.
It “balloons to a degree that, you know, becomes unmanageable,” Dr. Lane said.
FDA statisticians are now examining Mayo’s data to better understand what factors other than treatment may have influenced patients’ responses, such as higher-quality care in the hospital, Drs. Lane.
