Evaluation of a COVID-19 convalescent plasma program at a U.S. academic medical center

• Published in: PloS one 2022-12, Vol.17 (12), p.e0277707-e0277707
• Main Authors: Root, Heather B, Gilleskie, Matt, Lu, Chih-Huan, Gilmore, Andrew, Evans, Mariama, Nelson, Bridget G, Johnson, William, Gurney, Brian, Kuruc, JoAnn, Markmann, Alena J, Barzin, Amir H, Wohl, David A, Fischer, William A, Park, Yara A, Weiss, Susan, Napravnik, Sonia, Baric, Ralph, de Silva, Aravinda M, Lachiewicz, Anne M, van Duin, David, Margolis, David M, Herce, Michael E, Bartelt, Luther A
• Format: Article
• Language: English
• Subjects: Academic Medical Centers; Antibodies; Antibodies, Neutralizing; Biology and Life Sciences; Blood & organ donations; Consent; Coronaviruses; COVID-19; COVID-19 - epidemiology; COVID-19 - therapy; Critical mass; Disease transmission; Evaluation; Health care facilities; Health services; Hospitals; Humans; Intensive care; Laboratories; Medicine and Health Sciences; Pandemics; Patients; Personnel; Plasma; Research and Analysis Methods; Severe acute respiratory syndrome coronavirus 2; Viral infections
• ISSN: 1932-6203; 1932-6203
• DOI: 10.1371/journal.pone.0277707

Amidst the therapeutic void at the onset of the COVID-19 pandemic, a critical mass of scientific and clinical interest coalesced around COVID-19 convalescent plasma (CCP). To date, the CCP literature has focused largely on safety and efficacy outcomes, but little on implementation outcomes or experience. Expert opinion suggests that if CCP has a role in COVID-19 treatment, it is early in the disease course, and it must deliver a sufficiently high titer of neutralizing antibodies (nAb). Missing in the literature are comprehensive evaluations of how local CCP programs were implemented as part of pandemic preparedness and response, including considerations of the core components and personnel required to meet demand with adequately qualified CCP in a timely and sustained manner. To address this gap, we conducted an evaluation of a local CCP program at a large U.S. academic medical center, the University of North Carolina Medical Center (UNCMC), and patterned our evaluation around the dimensions of the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework to systematically describe key implementation-relevant metrics. We aligned our evaluation with program goals of reaching the target population with severe or critical COVID-19, integrating into the structure of the hospital-wide pandemic response, adapting to shifting landscapes, and sustaining the program over time during a compassionate use expanded access program (EAP) era and a randomized controlled trial (RCT) era. During the EAP era, the UNCMC CCP program was associated with faster CCP infusion after admission compared with contemporaneous affiliate hospitals without a local program: median 29.6 hours (interquartile range, IQR: 21.2-48.1) for the UNCMC CCP program versus 47.6 hours (IQR 32.6-71.6) for affiliate hospitals; (P