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.

Seroprevalence of Antibodies to SARS-CoV-2 in US Blood Donors

“…Most programs began with hospitals referring recovered COVID-19 patients to blood collection establishments. 5 The need for CCP has been publicized by governmental agencies, blood banking organizations, hospitals and blood collectors. Despite ample news outlet coverage, shortages of CCP occurred at program inception and again with case resurgence after relaxation of pandemic control restrictions.…”

“…Throughout successive iterations of FDA Guidance, CCP donor eligibility criteria have remained the same. 5 SARS-CoV-2 and other respiratory infections are not believed to represent a significant risk to blood safety. 6,7 Screening blood donations for SARS-CoV-2 virus appears unwarranted.…”

Pandemic treatments on trial: the bigger picture. N of many thinking in an N of one scenario

“…From early, uncontrolled results that reported a clinical improvement in 68% of 53 "analyzable" patients (10) through to a negative RCT study result involving 236 patients which was stopped early due to reduced case numbers in China resulting in a trial with reduced power to detect any smaller clinically significant benefit with any certainty (11) to further preliminary reports of potentially positive results in larger trials sponsored by the remdisivir patent holder (12). Similar stories abound for many other therapies being used to manage hospitalized patients with more severe COVID19 related illness including various respiratory support strategies and their combinations, a range of anticoagulation protocols, novel immunotherapeutic agents including the anti-IL6 receptor monoclonal antibody tocilizumab, and various combination strategies and therapies (13)(14)(15)(16)(17)(18)(19)(20)(21). At the other end of the spectrum are the much more inclusive, simplified and highly "capturing" RCT approaches such as the WHO Solidarity international clinical trial across multiple countries (22) and the Oxford University led RECOVERY trial in the UK (23)both designed to compare different treatment options against usual of care for as many hospitalised COVID patients as possible within their jurisdictions.…”

Rapidly Establishing a Hospital-Based Convalescent Plasma Collection Center With the Alyx Apheresis Collection Device

“…Both national blood collection centers and hospital blood banks have begun widespread local collection CP from donors, either by whole blood or apheresis collections. 3 Whole blood collections do not require collection instrument purchase; however, whole blood donations only yield 1 unit of CP (vs up to 4 units per collection by apheresis) and whole blood donors cannot donate more often than every 8 weeks (vs every 4 weeks or less for plasma donors). 4 On the other hand, venous access issues are more common, the cost is higher, and the collection time is longer for apheresis collections.…”