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Health/Medical Title: FDA fast tracking makes Houston Methodist first hospital to treat COVID-19 with recovered patient’s blood Houston Methodist Hospital doctors were all ready to go, but even they were a bit surprised late Saturday afternoon when word came down from the Food and Drug Administration. They could transfuse the blood from a former COVID-19 patient into one severely ill at the moment. The Methodist team sprang into action, using just-donated blood from a Houston-area individual whose symptoms had gone away weeks ago but whose antibodies to the coronavirus were now at optimal levels. By Saturday night, the blood was coursing through not just one but two COVID-19 patients in intensive care at Methodist. With that, the Houston hospital became the nation’s first to enlist convalescent serum therapy, a century-old idea, against the virus now spreading throughout the U.S. Methodist transfused the patients less than a week after the FDA announced it would facilitate use of the experimental therapy because of the expanding public health crisis. “Kudos to the FDA,” said Dr. Eric Salazar, a physician scientist at Methodist’s Research Institute who is leading the research effort. “They responded very rapidly.” On Sunday, Salazar said it is “too early still” to assess whether the transfused blood is helping the patients. But he said doctors are hopeful. That Methodist was the first to test the approach came as something of a surprise after New York Gov. Andrew Cuomo suggested last week it would happen there soon. After the FDA announcement, he said patient recruitment for plasma donations would begin in a matter of days, focused initially on the heavily hit New York City suburb of New Rochelle. In reality, Methodist’s team was pushing the effort just as furiously. The use of convalescent serum therapy dates back as far as the 1918 Spanish Influenza, when it was enlisted on quite a few patients with encouraging results. The approach also was used for the measles, mumps and polio in the first half of the 20th century before it became less relevant with the advent of vaccines and antiviral drugs. Though study of the idea that immunity can be transferred from a healthy individual to a sick one using convalescent plasma has met with varied results, a number of researchers think it’s worth reviving given the absence of any proven treatment for COVID-19, the disease caused by the new coronavirus. “It’s really a tried and true approach that has its limitation but has been shown to work in principle,” said Vineet Menachery , a virologist at the University of Texas Medical Branch in Galveston. “Transfusing antibodies that bind and inhibit the virus from growing in the blood definitely can reduce the viral load in patients.” UTMB showed convalescent serum therapy worked in experiments with mice infected with SARS, the new virus’ closely related cousin that in 2013 and 2014 spread globally . Doctors in China have used the approach in a small number of COVID-19 patients and suggested in a journal article last week that it’s been beneficial. Methodist had already submitted an application for a larger trial using the approach before the FDA announcement came down Tuesday that the agency would consider emergency uses. At that point, it began contacting former patients who had volunteered to the donate their blood. There didn’t figure to be as many strong candidates here as New York, just because the coronavirus began spreading there a few weeks before it started hitting Houston, important because donors aren’t eligible for the research for some time after being infected. “We are only at the point now that many of our potential donors’ plasma would be mature enough to use,” said Dr. James Musser, chair of Methodist’s department of pathology and genomic medicine. “That’s roughly 3½ to 4 weeks after their initial diagnosis, including two weeks in which they’re symptom free. That’s when their antibodies are at maximal level.” But one such former patient met the criteria last week. Methodist doctors collected and processed the individual’s blood Saturday, the day they applied to the FDA for emergency use of the therapy. With unusual speed, the agency fast-tracked the approval. On Sunday, Salazar and Musser expressed their gratitude to the donor. They said they were lucky the FDA acted so quickly. Musser said they expect to be ready to do more transfusions later this week as more donors’ blood becomes ready. Salazar said that more than two-thirds of Methodist patients — roughly 250 have tested positive for COVID-19 at the system's hospitals — may meet the criteria for donation. Donors each give a quart of blood plasma in a procedure much like donating whole blood. This is not the first revival of convalescent serum therapy. In the past two decades, it’s been used for SARS in 2003, swine flu in 2009 and Ebola in 2014. There’s no guarantee of its effectiveness, say researchers. There is no playbook for treatment, said Menachery. Its success can depend on blood variability from person to person, and the kinetics of when’s best to give it are unclear, though sooner is better. If it’s given late in the disease, sometimes too much damage has already already done. A playbook is what the new research aims to produce. Besides emergency uses approved on a case-by-case basis, Musser expects that the FDA will lump all the non-emergency trials being proposed by researchers into one umbrella trial that pools resources and findings. “It’s really remarkable how everyone’s come together on this in such a grassroots fashion,” said Musser. “It’s all hands on deck.”
Poster Comment: Gotta be a helluva lot more credible than that fraudulent fish tank cleaner being hyped by Rooty Giuliani's quack doctor... The FDA can move mighty fast when it's an emergency...
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