A group of four former US Food and Drug Administration officials are calling for the US to step up efforts to collect blood plasma from patients who have recovered from COVID-19 coronavirus disease and to advance clinical trials.
Blood plasma or convalescent plasma has been used in the past to treat other infectious diseases, including the 1918 flu, along with SARs, Ebola, and measles. The idea is that a person's success in producing antibodies can boost a newly infected patient's immune response.
"The United States could use such treatment urgently. The nation continues to struggle with high rates of hospitalization and tragic deaths. As vaccine development continues, it is important to advance every promising treatment option to improve the chances for the sick. "
The four – Mark McClellan, Margaret Hamburg, Robert Califf and Scott Gottlieb – wrote in a Washington Post statement that the United States is the world's leading supplier of plasma products.
"Now we are also the world's leading provider of coronavirus cases at around 60,000 a day. If convalescent plasma helps, it could help mitigate the effects of the pandemic," they wrote.
However, to get things right, randomized clinical trials are required, involving treated patients and other patients receiving normal care. So far, thousands of patients have been treated with plasma, but without proper studies it is impossible to know if plasma works.
The four scientists cited the example of hydroxychloroquine, the malaria drug that President Donald Trump, among others, touted as a possible treatment for COVID-19.
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Previous studies without randomization provided conflicting results that could not be interpreted. Subsequent randomized studies "showed no significant benefit and significant side effects and poorer results in some studies. The conclusion that hydroxychloroquine is not an advantage and allows us to draw attention to more promising treatments," they wrote.
Without randomization, it is impossible to know whether plasma is beneficial or something else that makes a patient feel better or worse.
The good news is that a group called "The Fight Is In Us" has emerged to raise awareness and recruit donors across the country. The federal government's ACTIV program, which is part of Operation Warp Speed, an accelerated attempt to develop COVID-19 treatments, is also conducting experiments with plasma and synthetic antibodies that use mechanisms similar to plasma to neutralize the virus. But only a few patients can participate in the plasma studies, they wrote.
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In the UK, the recovery study took a different approach and made it easier for patients and doctors to deal with registration and care. This study showed that steroids work in some patients and hydroxychloroquine does not. "Convalescence plasma is currently being studied, but there are far more patients who could participate in similar studies in the United States," the scientists wrote.
"Given the urgency of the Covid-19 crisis, we need to create new ways to quickly advance promising therapies while clearly determining whether they are safe and effective," said the chairman. "We cannot waste precious time and put people at risk by treating them with therapies that don't work or missing the opportunity to collect data and determine when treatment is beneficial."
The Wall Street Journal reported last week that the FDA is about to issue an emergency blood plasma approval, and an announcement could be made earlier this week.