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Transfusion ; 63(4): 703-710, 2023 04.
Article in English | MEDLINE | ID: covidwho-2255828


BACKGROUND: Early in the SARS-CoV-2 pandemic, many blood collection organizations (BCOs) were asked to collect and distribute COVID-19 convalescent plasma (CCP) as a potential treatment for this new virus and resulting disease. However, recruiting CCP donors presented unique challenges for BCOs, as there were few recovered patients at this time, and like the general population, most potential CCP donors had no blood donation experience. Thus, many CCP donors were new donors, and their donation motivations were unknown. MATERIALS AND METHODS: Donors who gave CCP at least once between April 27th and September 15th, 2020, were emailed a link to an online survey regarding their experience with COVID-19 and their motivations for donating CCP and blood. RESULTS: Of the 14,225 invitations sent, 3471 donors responded (24.4%). Most donors had never donated blood before (n = 1406), followed by lapsed donors (n = 1050), and recent donors (n = 951). There was a significant relationship between self-reported donation experience and fear of CCP donation (X2  = 119.2, p < .001). Motivations ranked "very important" by responding donors were wanting to help someone in need, a feeling of responsibility, and feeling a duty to donate. Donors with more severe disease were more likely to respond with feelings of a sense of duty to donate CCP (Χ2  = 8.078, p = .044) or altruism (Χ2  = 8.580, p = .035). CONCLUSIONS: Overwhelmingly, altruism and a sense of duty and responsibility were the reasons that CCP donors decided to donate. These insights can be useful for motivating donors for specialized donation programs or if wide scale CCP recruitment is needed in the future.

COVID-19 , Motivation , Humans , COVID-19/therapy , SARS-CoV-2 , COVID-19 Serotherapy , Tissue Donors , Blood Donors
PLoS Med ; 18(12): e1003872, 2021 12.
Article in English | MEDLINE | ID: covidwho-1581903


BACKGROUND: The United States (US) Expanded Access Program (EAP) to coronavirus disease 2019 (COVID-19) convalescent plasma was initiated in response to the rapid spread of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the causative agent of COVID-19. While randomized clinical trials were in various stages of development and enrollment, there was an urgent need for widespread access to potential therapeutic agents. The objective of this study is to report on the demographic, geographical, and chronological characteristics of patients in the EAP, and key safety metrics following transfusion of COVID-19 convalescent plasma. METHODS AND FINDINGS: Mayo Clinic served as the central institutional review board for all participating facilities, and any US physician could participate as a local physician-principal investigator. Eligible patients were hospitalized, were aged 18 years or older, and had-or were at risk of progression to-severe or life-threatening COVID-19; eligible patients were enrolled through the EAP central website. Blood collection facilities rapidly implemented programs to collect convalescent plasma for hospitalized patients with COVID-19. Demographic and clinical characteristics of all enrolled patients in the EAP were summarized. Temporal patterns in access to COVID-19 convalescent plasma were investigated by comparing daily and weekly changes in EAP enrollment in response to changes in infection rate at the state level. Geographical analyses on access to convalescent plasma included assessing EAP enrollment in all national hospital referral regions, as well as assessing enrollment in metropolitan areas and less populated areas that did not have access to COVID-19 clinical trials. From April 3 to August 23, 2020, 105,717 hospitalized patients with severe or life-threatening COVID-19 were enrolled in the EAP. The majority of patients were 60 years of age or older (57.8%), were male (58.4%), and had overweight or obesity (83.8%). There was substantial inclusion of minorities and underserved populations: 46.4% of patients were of a race other than white, and 37.2% of patients were of Hispanic ethnicity. Chronologically and geographically, increases in the number of both enrollments and transfusions in the EAP closely followed confirmed infections across all 50 states. Nearly all national hospital referral regions enrolled and transfused patients in the EAP, including both in metropolitan and in less populated areas. The incidence of serious adverse events was objectively low (<1%), and the overall crude 30-day mortality rate was 25.2% (95% CI, 25.0% to 25.5%). This registry study was limited by the observational and pragmatic study design that did not include a control or comparator group; thus, the data should not be used to infer definitive treatment effects. CONCLUSIONS: These results suggest that the EAP provided widespread access to COVID-19 convalescent plasma in all 50 states, including for underserved racial and ethnic minority populations. The study design of the EAP may serve as a model for future efforts when broad access to a treatment is needed in response to an emerging infectious disease. TRIAL REGISTRATION: NCT#: NCT04338360.

COVID-19/therapy , Compassionate Use Trials/methods , Health Services Needs and Demand/statistics & numerical data , Hospital Distribution Systems/organization & administration , Registries , Transfusion Reaction/complications , Transfusion Reaction/epidemiology , Adolescent , Adult , Aged , Aged, 80 and over , COVID-19/epidemiology , Ethnic and Racial Minorities , Female , Humans , Immunization, Passive/adverse effects , Immunization, Passive/methods , Inpatients , Male , Medically Underserved Area , Middle Aged , Pandemics , Patient Safety , SARS-CoV-2 , Treatment Outcome , United States , COVID-19 Serotherapy
Transfusion ; 61(5): 1471-1478, 2021 05.
Article in English | MEDLINE | ID: covidwho-1032304


BACKGROUND: With coronavirus disease 2019 (COVID-19) convalescent plasma (CCP) offering an early treatment option for COVID-19, blood collectors needed to quickly overcome obstacles to recruiting and qualifying eligible donors. We provide attributes of CCP donors and products and compare to standard donors and products. STUDY DESIGN AND METHODS: Information on CCP donors was gathered from the American Red Cross qualification website through product collection. Data from 2019 for standard plasma/platelet apheresis (SA) and whole blood (WB) donor demographics and SA donations including product disposition and reactions were used for comparison. RESULTS: Of almost 59 000 donors registering on the website, 75% reported an existing COVID-19 diagnostic polymerase chain reaction or an antibody test. The majority (56.2%) of 10 231 CCP donors were first-time donors in contrast to SA or WB donor populations, which were only 3.0% and 30.6%, respectively, first-time donors. The number of female donors was 12% higher than SA donors. Older (≥ 65 years) and younger (16-19 years) were comparatively underrepresented in CCP donors. Deferral (10.2%) and Quantity Not Sufficient rates (6.4%) for presenting CCP donations were higher than SA (8.2% and 1.1%, respectively). Human leukocyte antigen antibody reactivity was the highest cause of product loss for CCP donations vs SA donations (9.6% vs 1.3%). Acute adverse events also occurred at a higher rate among both first-time and repeat CCP donations compared to SA. CONCLUSIONS: CCP donors were more likely to be first-time and female donors than WB or SA donors. CCP donations had a higher rate of donor adverse reactions, deferrals, and product loss than SA donations.

Blood Component Removal , Blood Donors , COVID-19/blood , COVID-19/therapy , Convalescence , SARS-CoV-2/metabolism , Adolescent , Adult , Aged , Aged, 80 and over , Female , Humans , Immunization, Passive , Male , Middle Aged , COVID-19 Serotherapy