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4:13 PM, Feb 27, 2020

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Ask Dr. Nandi: FDA authorizes use of plasma from recovered patients to treat COVID-19

Posted at 5:28 AM, Aug 25, 2020
and last updated 2020-08-25 05:28:43-04

The FDA has authorized the use of convalescent plasma to treat patients sick with COVID-19.

The emergency authorization was granted yesterday and while plasma is seen as a promising therapy, the FDA says it does not yet represent a new standard of care.

Convalescent plasma has been around for a while. In fact, it’s actually a century-old approach that was used before we had vaccines to fend off some illnesses like the flu.

Now what happens when your body has an infection, is that it creates antibodies to fight the infection off. And these antibodies are found in a person’s blood. So when we talk about convalescent plasma, in terms of the virus, it basically means blood containing antibodies taken from people who have recovered from COVID-19.

The FDA looked at data that indicated that convalescent plasma for COVID is safe and “shows promising efficacy”. Meaning that so far, it’s helped some people, but the evidence to date has not been conclusive.

In fact, experts are still debating its effectiveness. But the FDA feels that the benefits outweigh the risks at this point in time. And they based their emergency authorization on the historical evidence of convalescent plasma that has worked in other outbreaks of respiratory viruses. Plus they also looked at small trials from China and the convalescent plasma program here in the US by the Mayo Clinic.

The program is actually called the National Expanded Access Protocol or EAP. And preliminary data from Mayo Clinic researchers found that of the 35,000 coronavirus patients that had been treated with plasma, there were actually fewer deaths when compared to patients who didn’t get the plasma.

Also, not surprisingly, they found patients who were treated with convalescent plasma that contained high levels of virus-fighting antibodies had a 35% improvement when it came to survival. And, the patients who were treated within three days of diagnosis did the best.

Remdesivir which is an intravenous antiviral medication has shown that it can shorten recovery time for hospitalized patients by 31%.

But a new study finds that it may not do so well with patients with moderate cases of COVID-19. Meaning patients that don’t need a ventilator to breathe. 600 patients were given a 5-day course of Remdesivir. And results showed Remdesivir did not improve clinical outcomes in hospitalized patients that had moderate pneumonia.