ABSTRACT
Background: The shortage of plasma products and the dependence on oversee supply is a known problem in Europe and has even aggravated during the COVID-19 pandemic. New ways and initiatives for plasma donations are strongly required. Thus, we established the first truly mobile plasma donation site in Germany, the "Plasma Bus". Method(s): We formed a "task force" for the bus-project including technicians, IT specialists, PR employees, the quality management department, a construction company, plasma machine operators and physicians. This team designed all the necessary equipment and procedures inside and around the bus and supervised the corresponding implementation steps. Suitable plasma machines and custom made storage for medical equipment and plasma products were selected and installed in the bus. All Requirements for a donation procedure following national guidelines were ensured. Instructions and SOPs were put in place for plasma donations in the bus. Result(s): Three "Aurora" plasmapheresis machines (Fresenius Kabi) were installed and validated in the plasma bus. All further requirements for donor management, plasma donation, storage and transportation were established. A VPN-tunnel based connection to the medical IT-system was implemented. The workflow for plasma donations in the bus was delineated in detail. Extensive staff-training for "in bus" donations took place. Conclusion(s): Mobile plasma donations based on the concept of a "plasma bus" are possible. They could be a helpful tool regarding the dramatic shortage of plasma. In addition, collection of plasma products with special requirements such as convalescent plasma may be expanded to rural areas. We compiled a model for this type of donation sites for identifying and overcoming potential pitfalls. Thereby we propose a blueprint for the implementation of a mobile plasma donation site.
ABSTRACT
Background: COVID-19 convalescent plasma (CCP) remains a potential therapy of COVID-19, e.g. for new variants and for patients with impaired immune response. The trial COVIC-19 takes into account lessons learned from previous trials and combines it to a novel approach: * CCP with very high levels of SARS-CoV-2 antibodies from donors with previous SARS-CoV-2 infection (inf) and vaccination (vax) * Treatment early after symptom onset * Treatment of vulnerable persons (e.g. immunocompromised) * Study of immune escape Methods: We report the initial experience of collection of very high-titer plasma units (defined as >=4.000 BAU/ml in the QuantiVac ELISA) for this COVIC-19 trial. We recruited 348 potential donors (151 male, 197 female) who had passed initial eligibility check. S-Ab were measured by anti-SARS-CoV-2 QuantiVac ELISA (Euroimmun): mean 4229 BAU/ml (IQR 2.239-5.486 BAU/ml). High S-Ab in the QuantiVac assay correlated with high neutralizing capacity in the GenScript surrogat neutralization assay. S-Ab was >=4.000 BAU/ml in 25.1% of the individuals and did not significantly differ by gender or ABO type, but were higher among those who had received 3 vax (median 4.231 BAU/ml) or 2 vax (median 2.954 BAU/ml) or 1 vax (median 1.832 BAU/ml)(p<0.01). Result(s): We analyzed the association between the order of immunizing events and S-Ab. Highest S-Ab were observed among those with a breakthrough infection after 2 vax, followed by a booster (3rd dose post inf.) (median 5.840 BAU/ml;76.7% >=4.000 BAU/ml) or breakthrough inf after 3 vax (no further booster;median 3.841 BAU/ml;47.9% >=4.000 BAU/ml). S-Ab were lower in those with inf before vax followed by 1 vax (median 1.806 BAU/ml;18.1% >=4.000 BAU/ml) or >1 vax (median 2.586 BAU/ ml). S-Ab declined rapidly: 42% of donors with S-Ab >=4.000 BAU/ml had declined below this threshold in the short interval until 1st plasmapheresis and further 6% until 2nd apheresis. Further follow-up will be presented. Conclusion(s): Taking into account all eligibility criteria only 8.6% of individuals willing to donate could provide plasma units meeting the criteria of high-titer plasma for COVIC-19. Collection of very-high titer plasma from super-immunized individuals with previous infection and vaccination is feasible, but requires substantial donor selection and rapid screening and immediate start of apheresis to take advantage of the short period of very high mAb.