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Business Observer Friday, Apr. 17, 2020 10 months ago

Hospital teams with Mayo Clinic for COVID-19 clinical trial

Mayo Clinic is the lead institution providing coordinated access to investigational convalescent plasma.

FORT MYERS — Lee Health, one of the largest medical and hospital systems in Florida, has been accepted and registered as a participating site in the COVID-19 Convalescent Plasma Study overseen by the Mayo Clinic.

Starting April 20, patients admitted to Lee Health hospitals with proven SARS-CoV-2 infection (the virus that causes COVID-19) may qualify to enroll in the clinical trial, according to a statement. The trial provides access to experimental convalescent plasma for the treatment of COVID-19.

The Mayo Clinic is the lead institution providing coordinated access to investigational convalescent plasma for hospitalized patients with severe or life-threatening COVID-19, or those who are at risk for the development for severe illness as judged by their doctors, the release states. The noted medical center was designated to do so by the Food and Drug Administration April 3.

Convalescent plasma refers to blood plasma collected from people who have recovered from COVID-19. That plasma is then used to treat others with advanced illness. The blood donor must have recovered from, and tested negative for, COVID-19 and be otherwise eligible to donate blood, according to the statement. After donation, the blood is processed in the lab to obtain the plasma component. The patient is transfused with the donor’s convalescent plasma, which contains antibodies that may attack the virus and may help the patient recover more rapidly.

Enrollment in the study is based on the protocol’s preset exclusion and inclusion criteria and on the availability of an appropriate blood-type matched unit of convalescent plasma. Being admitted to Lee Health with COVID-19 does not guarantee a patient will qualify for this trial, and even if a patient does qualify, because of probable limited convalescent plasma supplies, the patient may not be enrolled in this study and receive convalescent plasma. All participants will sign informed consent as required by the Mayo’s Institutional Review Board, a committee tasked with protecting the rights and welfare of human subjects.

In order to launch this study, Lee Health needs a supply of convalescent plasma and is asking patients who have tested positive for the virus and recovered to donate blood at one of its donation sites. This blood will be processed to make the convalescent plasma required for the clinical trial.

Lee Health has multiple locations in Southwest Florida, with more than 13,130 employees, 4,500 volunteers and 1,480 physicians.

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