April 16, 2020 – Starting Monday, April 20, patients who are being admitted to Lee Health hospitals with proven SARS-CoV-2 infection (the virus that causes COVID-19) may qualify to enroll in a clinical trial providing access to experimental convalescent plasma for the treatment of COVID-19.
Lee Health has been accepted and registered as a participating site in Mayo Clinic’s COVID-19 Convalescent Plasma Study.
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, and was designated to do so by the Food and Drug Administration (FDA) on 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. 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.
There is no known safe and effective treatment for COVID-19. As in any clinical research study, it is unknown if the treatment will be therapeutic and there are risks involved. However, based on its use to treat other viral infections, researchers hypothesize that the plasma from recovered patients may contain antibodies that may help fight the disease.
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.
Here’s how the donation program will work at Lee Health:
•Individuals who have previously tested positive for COVID-19 whose symptoms have resolved can volunteer to donate blood.
•Donors are screened by clinical personnel with questions and tests to make sure they are appropriate to donate blood that will be processed to make COVID-19 convalescent plasma.
•To volunteer, call 239-343-2332 or email COVID.plasma@LeeHealth.org (E-mail preferred)
•Documented routine blood donation consent is required; forms will be made available by Lee Health.
•All donors will be screened with a nasal swab test for SARS-CoV-2. The test result must be negative before proceeding.
•If potential donors are appropriate, an appointment for blood donation is scheduled at a Lee Health donation site
All donations collected by Lee Health will stay in our community and will be used exclusively for Lee Health patients.
About Lee Health
Since the opening of the first hospital in 1916, Lee Health has been a health care leader in Southwest Florida, constantly evolving to meet the needs of the community. A non-profit, integrated health care services organization, Lee Health is committed to the well-being of every individual served, focused on healthy living and maintaining good health. Staffed by caring people, inspiring health, services are conveniently located throughout the community in four acute care hospitals, two specialty hospitals, outpatient centers, walk-in medical centers, primary care and specialty physician practices and other services across the continuum of care. Learn more at www.LeeHealth.org.
