Rapid Development of a De Novo Convalescent Plasma Program in Response to a Global Pandemic: A Large Southeastern U.S. Blood Center's Experience

Background: With no vaccine or treatment for SARS-CoV-2 and its associated disease, COVID-19, convalescent plasma from recovered COVID-19 (CCP) patients offered a potential therapy. In March of 2020, the United States (US) Food and Drug Administration (FDA) authorized CCP under emergency Investigational New Drug (eIND) exemption and an IRB-approved Expanded Access Program (EAP) to treat severe COVID-19. Hospital demand grew rapidly in the Southeastern US, resulting in backlogs of CCP orders. We describe a large US blood center's (BC) rapid implementation of a CCP program in response to community needs. Study Design and Methods: From April 2 to May 17, 2020 CCP was collected by whole blood or apheresis. Initial manual approaches to donor intake, collection and distribution were rapidly replaced with automated processes. All CCP donors and products underwent FDA-required screening and testing. Results: 619 CCP donors (299 females, 320 males) presented for CCP donation [161 (25.6%) whole blood, 466 (74.1%) plasmapheresis] resulting in 1219 CCP units. Production of CCP increased as processes were automated and streamlined, from a mean of 11 donors collected/day for the first month to a mean of 25 donors collected/day in the subsequent two weeks. Backlogged orders were cleared, and inventory began to accumulate 4 weeks after project initiation. Conclusion: The BC was able to implement an effective de novo CCP collection program within 6 weeks in response to a community need in a global pandemic. Documentation of the experience may inform preparedness for future pandemics.