The safety of COVID-19 convalescent plasma donation: A multi-institutional donor hemovigilance study.

BACKGROUND: Although the safety and therapeutic efficacy of COVID-19 convalescent plasma (CCP) has been extensively evaluated, the safety of CCP donation has not been explored in a multi-institutional context. STUDY DESIGN AND METHODS: Nine blood collection organizations (BCOs) participated in a multi-institutional donor hemovigilance effort to assess the safety of CCP donation. Donor adverse events (DAEs) were defined according to the Standard for Surveillance of Complications Related to Blood Donation, and severity was assessed using the severity grading tool. Multivariate analysis was performed to determine attributes associated with DAE severity. RESULTS: The overall DAE rate was 37.7 per 1000 donations. Repeat apheresis and apheresis-naïve donors experienced adverse event rates of 19.9 and 49.8 per 1000 donations, respectively. Female donors contributed 51.9% of CCP donations with a DAE rate of 49.4 per 1000 donations. The DAE rate for male donors was 27.4 per 1000 donations. Vasovagal reactions accounted for over half of all reported DAEs (51.1%). After adjustment, volume of CCP donated was associated with vasovagal reaction severity (odds ratio [OR] 6.5, 95% confidence interval [CI] 2.5-17.1). Donor age and donation history were also associated with DAE severity. Considerable differences in DAE types and rates were observed across the participating BCOs despite the use of standardized hemovigilance definitions. CONCLUSION: The safety of CCP donation appears comparable to that of conventional apheresis plasma donation with similar associated risk factors for DAE types and severity.

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: During the pandemic in the spring of 2020 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 2020, the United States (U.S.) 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 U.S., resulting in backlogs of CCP orders. We describe a large U.S. 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: A total of 619 CCP donors (299 females, 320 males) presented for CCP donation (161 [25.7%] whole blood, 466 [74.3%] 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 2 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.

The effect of COVID-19 on blood donation habits.

BACKGROUND: Blood centers (BCs) rely on schools and businesses. Shelter-in-place orders closed them. This study determined how COVID-19 affected donation habits. STUDY DESIGN AND METHODS: Two periods were reviewed (May 1 through June 30, 2018 vs 2019 [control] and 2019 vs 2020 [study-COVID period]). These donations were reviewed: first-time, repeat (donation ≤ 2 years), and lapsed (no donation > 2 years); sex; age; ethnicity; and ABO blood groups at high school and college drives. Testing all donors for SARS-CoV-2 antibodies started May 18, 2020. RESULTS: In the study period donations significantly increased (control P = .683, study P ≤ .0001) and comparing sex (control male P = .716, female P = .657; study male P = .004, female P ≤ .0001). In the study period there was a significant decrease in Hispanic (P = .001) and African American (P < .0001) donations also seen among high school and college drives and an increase in Caucasian (P < .0001) donations. There was a significant increase in first-time (P < .0001) and lapsed donors (P < .0001) in the study period vs control (first-time P = .087, lapsed P = .308) and a significant decrease in donors not more than 30 years (study 16-20 P < .0001, 21-30 P < .0001). There was a significant increase in all blood types in the study period (P < .0001) and in donations after implementation of SARS-CoV-2 antibody testing (P = .001). CONCLUSIONS: Significant changes occurred in donation habits in the study vs the control periods. These included increased total donations, comparing sexes, first-time and lapsed donors, all blood types, and Caucasian donations. Significant decreases were seen in Hispanic and African American donations and those not more than 30 years old.