Potential COVID-19 treatment approved by FDA now on hold

HOUSTON, Texas (KTRK) -- A possible breakthrough in treating COVID-19 is not getting the fast approval initially thought.

Last week, the Food and Drug Administration was getting ready to issue an emergency authorization for blood plasma treatment in coronavirus patients. Then, top federal health officials, including Dr. Anthony Fauci, argued that the data was too weak and more testing should be done.

Plasma is the yellow liquid that leaves the body after blood.

According to researchers, potential life-saving antibodies live in the plasma of a person who has recovered from COVID-19. Twenty-one to 28 days after a person with coronavirus recovers, blood can be drawn to look for COVID-19 antibodies.

The idea is that if a person sick with COVID-19 is given the antibody-rich plasma, they will recover.

SEE RELATED STORY: COVID-19 survivor hopes to encourage others to donate plasma

"Of all the myriad of medications and treatment available for coronavirus, this is the one that has promise," said Dr. Henry Wang, professor of emergency medicine at UTHealth.

As of now, experts say there haven't been enough clinical trials to prove the theory. Wang points out there are hundreds of examples of treatments that seem to make sense on paper, but when they're put to the test, they don't work.

"Our experts are absolutely right," Wang said. "The gold standard test of effectiveness of intervention is the randomized control trial. Until we do that randomized controlled trial, we don't really know if the medication works."

UTHealth is ready to help generate that data.

They just received an $8 million grant to launch a placebo-controlled study to determine if in fact plasma really does work to help COVID-19 patients recover.

The study is both randomized, meaning some patients will receive the plasma and some will receive placebo, and blinded, meaning the doctors won't know which treatment the patient has received.

SEE RELATED STORY: Pregnant woman survives COVID-19 after given plasma from other survivor

Hospitals and universities in New York City and Miami are also part of the study. About 1,000 people are participating. Most of the people participating in the Houston trials are patients at Memorial Hermann.

"I've heard of individual patients that have done extremely well after receiving doses of plasma, so, of course, I have high hopes," Wang said.

There is also encouraging research happening at Houston Methodist. Results from a plasma trial published last week show 136 patients who received plasma treatment were more likely to be alive four weeks later, compared with 251 patients who did not receive it. That study found a significantly better outcome only when patients were treated within three days of getting the plasma, and, when the plasma contained a high amount of antibodies.

Dr. Anand Shah, the FDA's deputy commissioner for medical and scientific affairs, told reporters Thursday morning the government will notify the public when they've made a decision whether or not to authorize convalescent plasma as a treatment.

"We've launched a partnership with the Mayo Clinic...which allows for wide national access to patients who desire COVID convalescent plasma for COVID-19," Shah said. "That expanded access protocol has enrolled over 60,000 patients and we are actively looking at the safety and efficiency of the data that's been generated."

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