How did we rapidly implement a convalescent plasma program?

Abstract

Since the beginning of the COVID-19 pandemic, the use of convalescent plasma as a possible treatment has been explored. Here we describe our experience as the first U.S. organization creating a COVID-19 convalescent plasma program to support its use through the single-patient emergency investigational new drug, the National Expanded Access Program, and multiple randomized controlled trials. Within weeks, we were able to distribute more than 8000 products, scale up collections to more than 4000 units per week, meet hospital demand, and support randomized controlled trials to evaluate the efficacy of convalescent plasma treatment. This was through strategic planning; redeployment of staff; and active engagement of hospital, community, and public health partners. Our partners helped with donor recruitment, testing, patient advocacy, and patient availability. The program will continue to evolve as we learn more about optimizing the product. Remaining issues to be resolved are antibody titers, dose, and at what stage of disease to transfuse.

Fig. 1

Phase implementation of CCP collection. Figure shows the differences between Phase I and Phase II processes.

Fig. 2

Sample CCP label. In addition to general labeling requirements, CCP units are additionally labeled with “Convalescent Plasma Anti‐SARS‐CoV‐2 Immune Plasma.” An IND statement is also a requirement.

Fig. 3

Collection and distribution of CCP units over time. Bars represent the number of units collected (blue) and distributed (orange) by week. Differences in collection and distribution largely represent collected units that did not meet patient transfusion requirements (i.e., HLA antibodies detected, positive ID markers). Some represent units about to be distributed, but in house at time of data collection. [Color figure can be viewed at wileyonlinelibrary.com]

Fig. 4

Scale up of CCP collection. Figure highlights improvements in the process to greatly increase the supply of CCP.