Christ Hospital gets FDA approval for plasma clinical trial

Christ Hospital gets FDA approval for COVID-19 plasma clinical trial
Updated: Apr. 10, 2020 at 8:15 PM EDT
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CINCINNATI, Ohio (FOX19) - The Food and Drug Administration has fast-tracked approval for a project that could save the lives of patients battling the coronavirus -- and one of the clinical trial sites is in Cincinnati.

Lt. Gov. John Husted announced Thursday the FDA had approved the protocol created by the Lindner Research Center at The Christ Hospital.

The study now being performed there takes plasma from recovered COVID-19 patients and uses it as a therapy to treat the sickest of patients with the virus.

While COVID-19 currently has no proven treatment, it is possible that convalescent plasma, a component of blood from patients that have recovered from COVID-19, may provide antibodies to fight the virus.

Dean Kereiakes, MD, Medical Director of the Christ Hospital Research Institute, is the primary investigator on the clinical trial.

Tuesday night Kereiakes says he texted Husted, and by Wednesday morning the hospital got the go-ahead from the FDA.

Kereiakes has been part of more than 1,600 FDA-approved clinical trials and he hopes this latest one will prove a game-changer.

“Because we have identified a simple, readily available, cheap, rapid-turnaround time test used in every emergency room in the United States," he explained, adding the test takes less than an hour.

Kereiakes explains because there are no specific antiviral drugs or vaccines for COVID-19, effective treatments are needed to rescue the sickest.

“Here is what people can do, that is, to come in and give plasma," he said. "That is what we need is for the public or have survived this to do. The rate-limiting step is the lack of plasma, convalescent plasma from people that have survived this infection. That is what we have to have at Christ.”

Husted said other hospitals in Cincinnati and around the state have expressed interest in participating in the treatment protocol.

“This type of therapy is more than 100 years old and was used during the 1918 flu pandemic, a time when antiviral drugs and most vaccines did not exist,” Chief Medical Officer Dr. David Oh said in a news release. “This approach was used for polio, measles and mumps.”

Kereiakes is working with David Oh, MD, Chief Medical Director of Hoxworth Blood Center at the University of Cincinnati to collect and distribute convalescent plasma.

Oh explains the convalescent plasma treatment is an old one.

“This type of therapy is more than 100 years old and was used during the 1918 flu pandemic, a time when antiviral drugs and most vaccines did not exist,” Oh said. “This approach was used for polio, measles and mumps.”

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