tetano
Editor, Senior Moderator
J Infect Chemother
. 2023 May 11;S1341-321X(23)00122-8.
doi: 10.1016/j.jiac.2023.05.012. Online ahead of print. Efficacy of convalescent plasma therapy for COVID-19 in Japan: An open-label, randomized, controlled trial
Sho Saito[SUP] 1 [/SUP], Satoshi Kutsuna[SUP] 2 [/SUP], Imamura Akifumi[SUP] 3 [/SUP], Ryota Hase[SUP] 4 [/SUP], Rentaro Oda[SUP] 5 [/SUP], Junko Terada[SUP] 6 [/SUP], Yosuke Shimizu[SUP] 6 [/SUP], Yukari Uemura[SUP] 6 [/SUP], Yuki Takamatsu[SUP] 7 [/SUP], Akemi Yasuhara[SUP] 8 [/SUP], Katsuyuki Shiratori[SUP] 9 [/SUP], Masahiro Satake[SUP] 10 [/SUP], Naoya Sakamoto[SUP] 11 [/SUP], Yasunari Miyazaki[SUP] 12 [/SUP], Hidefumi Shimizu[SUP] 13 [/SUP], Tomiteru Togano[SUP] 14 [/SUP], Akihiro Matsunaga[SUP] 15 [/SUP], Kazu Okuma[SUP] 16 [/SUP], Isao Hamaguchi[SUP] 17 [/SUP], Kyoko Fujisawa[SUP] 18 [/SUP], Maki Nagashima[SUP] 18 [/SUP], Shinobu Ashida[SUP] 18 [/SUP], Mari Terada[SUP] 19 [/SUP], Akiko Kimura[SUP] 6 [/SUP], Shinichiro Morioka[SUP] 18 [/SUP], Keiji Matsubayashi[SUP] 10 [/SUP], Nelson Hirokazu Tsuno[SUP] 20 [/SUP], Makiko Kojima[SUP] 21 [/SUP], Madoka Kuramitsu[SUP] 17 [/SUP], Kenta Tezuka[SUP] 17 [/SUP], Emi Ikebe[SUP] 17 [/SUP], Yukihito Ishizaka[SUP] 15 [/SUP], Maeda Kenji[SUP] 7 [/SUP], Akira Hangaishi[SUP] 14 [/SUP], Ayako Mikami[SUP] 6 [/SUP], Wataru Sugiura[SUP] 6 [/SUP], Norio Ohmagari[SUP] 18 [/SUP], Hiroaki Mitsuya[SUP] 7 [/SUP]
Affiliations
Background: Convalescent plasma is a potential therapeutic option for patients with coronavirus disease 2019 (COVID-19). Despite its use for treating several viral infections, we lack comprehensive data on its efficacy against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
Methods: We conducted a multicenter, open-label, randomized controlled trial of convalescent plasma therapy with high neutralizing activity against SARS-CoV-2 in high-risk patients within five days after the onset of COVID-19 symptoms. The primary endpoint was the time-weighted average change in the SARS-CoV-2 viral load in nasopharyngeal swabs from days 0-5.
Results: Between February 24, 2021, and November 30, 2021, 25 patients were randomly assigned to either convalescent plasma (n = 14) or standard of care (n = 11) groups. Four patients discontinued their allocated convalescent plasma, and 21 were included in the modified intention-to-treat analysis. The median interval between the symptom onset and plasma administration was 4.5 days (interquartile range, 3-5 days). The primary outcome of the time-weighted average change in the SARS-CoV-2 viral load in nasopharyngeal swabs did not significantly differ between days 0-5 (1.2 log[SUB]10[/SUB] copies/mL in the convalescent plasma vs. 1.2 log[SUB]10[/SUB] copies/mL in the standard of care (effect estimate, 0.0 [95% confidence interval, -0.8-0.7]; P = 0.94)). No deaths were observed in either group.
Conclusions: The early administration of convalescent plasma with high neutralizing activity did not contribute to a decrease in the viral load within five days compared with the standard of care alone.
Keywords: Convalescent plasma; Efficacy; Japan; SARS-CoV-2; Viral load.
. 2023 May 11;S1341-321X(23)00122-8.
doi: 10.1016/j.jiac.2023.05.012. Online ahead of print. Efficacy of convalescent plasma therapy for COVID-19 in Japan: An open-label, randomized, controlled trial
Sho Saito[SUP] 1 [/SUP], Satoshi Kutsuna[SUP] 2 [/SUP], Imamura Akifumi[SUP] 3 [/SUP], Ryota Hase[SUP] 4 [/SUP], Rentaro Oda[SUP] 5 [/SUP], Junko Terada[SUP] 6 [/SUP], Yosuke Shimizu[SUP] 6 [/SUP], Yukari Uemura[SUP] 6 [/SUP], Yuki Takamatsu[SUP] 7 [/SUP], Akemi Yasuhara[SUP] 8 [/SUP], Katsuyuki Shiratori[SUP] 9 [/SUP], Masahiro Satake[SUP] 10 [/SUP], Naoya Sakamoto[SUP] 11 [/SUP], Yasunari Miyazaki[SUP] 12 [/SUP], Hidefumi Shimizu[SUP] 13 [/SUP], Tomiteru Togano[SUP] 14 [/SUP], Akihiro Matsunaga[SUP] 15 [/SUP], Kazu Okuma[SUP] 16 [/SUP], Isao Hamaguchi[SUP] 17 [/SUP], Kyoko Fujisawa[SUP] 18 [/SUP], Maki Nagashima[SUP] 18 [/SUP], Shinobu Ashida[SUP] 18 [/SUP], Mari Terada[SUP] 19 [/SUP], Akiko Kimura[SUP] 6 [/SUP], Shinichiro Morioka[SUP] 18 [/SUP], Keiji Matsubayashi[SUP] 10 [/SUP], Nelson Hirokazu Tsuno[SUP] 20 [/SUP], Makiko Kojima[SUP] 21 [/SUP], Madoka Kuramitsu[SUP] 17 [/SUP], Kenta Tezuka[SUP] 17 [/SUP], Emi Ikebe[SUP] 17 [/SUP], Yukihito Ishizaka[SUP] 15 [/SUP], Maeda Kenji[SUP] 7 [/SUP], Akira Hangaishi[SUP] 14 [/SUP], Ayako Mikami[SUP] 6 [/SUP], Wataru Sugiura[SUP] 6 [/SUP], Norio Ohmagari[SUP] 18 [/SUP], Hiroaki Mitsuya[SUP] 7 [/SUP]
Affiliations
- PMID: 37178973
- PMCID: PMC10174342
- DOI: 10.1016/j.jiac.2023.05.012
Background: Convalescent plasma is a potential therapeutic option for patients with coronavirus disease 2019 (COVID-19). Despite its use for treating several viral infections, we lack comprehensive data on its efficacy against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
Methods: We conducted a multicenter, open-label, randomized controlled trial of convalescent plasma therapy with high neutralizing activity against SARS-CoV-2 in high-risk patients within five days after the onset of COVID-19 symptoms. The primary endpoint was the time-weighted average change in the SARS-CoV-2 viral load in nasopharyngeal swabs from days 0-5.
Results: Between February 24, 2021, and November 30, 2021, 25 patients were randomly assigned to either convalescent plasma (n = 14) or standard of care (n = 11) groups. Four patients discontinued their allocated convalescent plasma, and 21 were included in the modified intention-to-treat analysis. The median interval between the symptom onset and plasma administration was 4.5 days (interquartile range, 3-5 days). The primary outcome of the time-weighted average change in the SARS-CoV-2 viral load in nasopharyngeal swabs did not significantly differ between days 0-5 (1.2 log[SUB]10[/SUB] copies/mL in the convalescent plasma vs. 1.2 log[SUB]10[/SUB] copies/mL in the standard of care (effect estimate, 0.0 [95% confidence interval, -0.8-0.7]; P = 0.94)). No deaths were observed in either group.
Conclusions: The early administration of convalescent plasma with high neutralizing activity did not contribute to a decrease in the viral load within five days compared with the standard of care alone.
Keywords: Convalescent plasma; Efficacy; Japan; SARS-CoV-2; Viral load.