How we secured a COVID‐19 convalescent plasma procurement scheme in Japan

Abstract

Background In order to tackle the COVID‐19 pandemic, a COVID‐19 convalescent plasma (CCP) procurement program was initiated in Japan in April 2020. The program was a collaboration between a government‐managed national hospital, an infectious disease research institute, and a blood banking organization. Each party assumed different responsibilities: recruitment, SARS‐CoV‐2 antibody profiling, and plasmapheresis; conduction of screening tests; and SARS‐CoV‐2 blood testing, respectively. Methods We adopted a two‐point screening approach before the collected CCP was labeled as a CCP product for investigational use, for which we mainly tested anti‐SARS‐CoV‐2 antibody eligibility and blood product eligibility. Anti‐SARS‐CoV‐2 spike protein titer was measured using enzyme‐linked immunosorbent assay, and the IC 50 value was denoted as the neutralizing activity. Blood donor eligibility was extended beyond the normal blood donation guidelines to include a broader range of participants. After both eligibility criteria were confirmed, participants were asked to revisit the hospital for blood donation, which is a unique aspect of the Japanese CCP program, as most donations are taking place in normal blood donation venues in other countries. Some donors were re‐scheduled for repeat plasma donations. As public interest in anti‐SARS‐CoV‐2 antibodies increased, test results were given to the participants. Results As of September 17, 2020, our collection of CCP products was sufficient to treat more than 100 patients. As a result, projects for administration and distribution are also being conducted. Conclusions We successfully implemented a CCP procurement scheme with the goal to expand to other parts of the country to improve treatment options for COVID‐19.

Factors associated with development and persistence of post-COVID conditions: A cross-sectional study

“…The participants recruited in this study were patients who had recovered from COVID-19 and who visited the outpatient service of the Disease Control and Prevention Center in the NCGM from February 2020 to March 2021 to undergo a pre-donation screening test for COVID-19 convalescent plasmapheresis [ 6 ]. Most of the participants had received acute-phase treatment for COVID-19 in other hospitals and all participants in this study were Japanese since the screening test was designed only for Japanese patients.…”

Safety of convalescent plasma therapy for COVID-19 patients and analysis of viral kinetics: a single-center, open-label, single-arm, interventional study in Japan

“…Recruitment of COVID-19 convalescent patients was performed for plasma collection (15). Blood samples were taken from COVID-19 recovering patients who were at least 3 weeks from the date of onset for measurement of laboratory data.…”

SARS-CoV-2-neutralizing humoral IgA response occurs earlier but modest and diminishes faster compared to IgG response

“…Fourteen individuals who were diagnosed with COVID-19 based on the positive RNA-quantitative-PCR (RNA-qPCR) results from February to April 2020 and eight individuals who received COVID-19 mRNA-vaccine (either BNT162b2 or mRNA-1273) from April to July 2021 after the recovery from COVID-19, and agreed to participate in the clinical studies (Certified Review Board of National Center for Global Health and Medicine approval numbers NCGM-G-003472 and NCGM-G-003536) for specimen collection and convalescent plasma donation [10,15] were enrolled in the present work. The data were analyzed anonymously.…”