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

Kutsuna S, Saito S, Takamatsu Y, Terada M, Togano T, Kinoshita N, Maeda K, Matsunaga A, Satake M, Matsubayashi K, Tsuno NH, Kojima M, Kuramitsu M, Tezuka K, Ikebe E, Okuma K, Hamaguchi I, Shimanishi Y, Hangaishi A, Ishizaka Y, Ohmagari N, Mitsuya H

Convalescent plasma therapy is an important treatment method for patients with severe coronavirus disease (COVID-19). This study was conducted to confirm the safety of this therapy. We conducted an open-label clinical trial to administer convalescent plasma transfusion in a small Japanese cohort. Blood was collected from the recovered COVID-19 patients with high anti-severe acute respiratory syndrome coronavirus 2 (anti-SARS-CoV-2) spike IgG titer and high neutralizing activity and stored in the National Center for Global Health and Medicine Hospital until use. Convalescent plasma was administered to COVID-19 patients who required supplemental oxygen within 3 days of hospitalization. Convalescent plasma was administered to 11 patients with moderate to severe COVID-19. One patient experienced an adverse event, such as redness of the skin around the intravenous injection site within 3 hours after transfusion. Ten patients (91%) showed clinical improvement within 28 days, and one patient died of causes unrelated to plasma therapy. The data suggest that patients with COVID-19 examined in the present study received convalescent plasma without having any significant adverse effects. We plan to conduct a randomized controlled trial to examine the clinical effectiveness of convalescent plasma transfusion in a large Japanese COVID-19 cohort.

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