Efficacy of convalescent plasma therapy for COVID-19 in Japan: An open-label, randomized, controlled trial.

Humans COVID-19 / therapy SARS-CoV-2 Japan COVID-19 Serotherapy Immunization, Passive / adverse effects Treatment Outcome
Convalescent plasma Efficacy Japan SARS-CoV-2 Viral load

Journal

Journal of infection and chemotherapy : official journal of the Japan Society of Chemotherapy
ISSN: 1437-7780
Titre abrégé: J Infect Chemother
Pays: Netherlands
ID NLM: 9608375

Informations de publication

Date de publication:
Sep 2023
Historique:
received: 19 02 2023
revised: 13 04 2023
accepted: 10 05 2023
medline: 2 8 2023
pubmed: 14 5 2023
entrez: 13 5 2023
Statut: ppublish

Résumé

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). 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. 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 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.

Sections du résumé

BACKGROUND 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 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 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
CONCLUSIONS 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.

Identifiants

DOI: 10.1016/j.jiac.2023.05.012 PMID: 37178973 PMC: PMC10174342
pubmed: 37178973
pii: S1341-321X(23)00122-8
doi: 10.1016/j.jiac.2023.05.012
pmc: PMC10174342
pii:
doi:

Types de publication

Randomized Controlled Trial Multicenter Study Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

869-874

Informations de copyright

Copyright © 2023 Japanese Society of Chemotherapy, Japanese Association for Infectious Diseases, and Japanese Society for Infection Prevention and Control. Published by Elsevier Ltd. All rights reserved.

Déclaration de conflit d'intérêts

Declaration of competing interest The authors declare that they have no conflicts of interest.

Auteurs

Sho Saito (S)

Disease Control and Prevention Center, National Center for Global Health and Medicine, Tokyo, Japan. Electronic address: ssaito@hosp.ncgm.go.jp.

Satoshi Kutsuna (S)

Disease Control and Prevention Center, National Center for Global Health and Medicine, Tokyo, Japan; Department of Infection Control, Graduate School of Medicine Faculty of Medicine, Osaka University, Osaka, Japan.

Imamura Akifumi (I)

Department of Infectious Diseases, Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital, Tokyo, Japan.

Ryota Hase (R)

Department of Infectious Diseases, Japanese Red Cross Narita Hospital, Chiba, Japan.

Rentaro Oda (R)

Division of Infectious Diseases, Tokyo Bay Urayasu Ichikawa Medical Center, Chiba, Japan.

Junko Terada (J)

Center for Clinical Science, National Center for Global Health and Medicine, Tokyo, Japan.

Yosuke Shimizu (Y)

Center for Clinical Science, National Center for Global Health and Medicine, Tokyo, Japan.

Yukari Uemura (Y)

Center for Clinical Science, National Center for Global Health and Medicine, Tokyo, Japan.

Yuki Takamatsu (Y)

Department of Refractory Viral Infections, National Center for Global Health and Medicine Research Institute, Tokyo, Japan.

Akemi Yasuhara (A)

Joint Center for Researchers, Associates and Clinicians Data Center, Department of Data Science, Center for Clinical Sciences, National Center for Global Health and Medicine, Tokyo, Japan.

Katsuyuki Shiratori (K)

Clinical Laboratory Department, National Center for Global Health and Medicine, Tokyo, Japan.

Masahiro Satake (M)

Japanese Red Cross Central Blood Institute, Tokyo, Japan.

Naoya Sakamoto (N)

Department of Infectious Diseases, Tokyo Metropolitan Bokutoh Hospital, Tokyo, Japan.

Yasunari Miyazaki (Y)

Department of Respiratory Medicine, Tokyo Medical and Dental University, Tokyo, Japan.

Hidefumi Shimizu (H)

Department of Respiratory Medicine, JCHO Tokyo Shinjuku Medical Center, Tokyo, Japan.

Tomiteru Togano (T)

Department of Hematology, National Center for Global Health and Medicine, Tokyo, Japan.

Akihiro Matsunaga (A)

Department of Intractable Diseases, National Center for Global Health and Medicine, Tokyo, Japan.

Kazu Okuma (K)

Department of Safety Research on Blood and Biological Products, National Institute of Infectious Diseases, Tokyo, Japan; Department of Microbiology, Faculty of Medicine, Kansai Medical University, Osaka, Japan.

Isao Hamaguchi (I)

Department of Safety Research on Blood and Biological Products, National Institute of Infectious Diseases, Tokyo, Japan.

Kyoko Fujisawa (K)

Disease Control and Prevention Center, National Center for Global Health and Medicine, Tokyo, Japan.

Maki Nagashima (M)

Disease Control and Prevention Center, National Center for Global Health and Medicine, Tokyo, Japan.

Shinobu Ashida (S)

Disease Control and Prevention Center, National Center for Global Health and Medicine, Tokyo, Japan.

Mari Terada (M)

Disease Control and Prevention Center, National Center for Global Health and Medicine, Tokyo, Japan; Center for Clinical Science, National Center for Global Health and Medicine, Tokyo, Japan.

Akiko Kimura (A)

Center for Clinical Science, National Center for Global Health and Medicine, Tokyo, Japan.

Shinichiro Morioka (S)

Disease Control and Prevention Center, National Center for Global Health and Medicine, Tokyo, Japan.

Keiji Matsubayashi (K)

Japanese Red Cross Central Blood Institute, Tokyo, Japan.

Nelson Hirokazu Tsuno (NH)

Japanese Red Cross Kanto-Koshin-etsu Block Blood Center, Tokyo, Japan.

Makiko Kojima (M)

Japanese Red Cross Central Blood Institute, Tokyo, Japan; Japanese Red Cross Kanto-Koshin-etsu Block Blood Center, Tokyo, Japan.

Madoka Kuramitsu (M)

Department of Safety Research on Blood and Biological Products, National Institute of Infectious Diseases, Tokyo, Japan.

Kenta Tezuka (K)

Department of Safety Research on Blood and Biological Products, National Institute of Infectious Diseases, Tokyo, Japan.

Emi Ikebe (E)

Department of Safety Research on Blood and Biological Products, National Institute of Infectious Diseases, Tokyo, Japan.

Yukihito Ishizaka (Y)

Department of Intractable Diseases, National Center for Global Health and Medicine, Tokyo, Japan.

Maeda Kenji (M)

Department of Refractory Viral Infections, National Center for Global Health and Medicine Research Institute, Tokyo, Japan.

Akira Hangaishi (A)

Department of Hematology, National Center for Global Health and Medicine, Tokyo, Japan.

Ayako Mikami (A)

Center for Clinical Science, National Center for Global Health and Medicine, Tokyo, Japan; Center for Clinical Research, National Center for Child Health and Development, Tokyo, Japan.

Wataru Sugiura (W)

Center for Clinical Science, National Center for Global Health and Medicine, Tokyo, Japan.

Norio Ohmagari (N)

Disease Control and Prevention Center, National Center for Global Health and Medicine, Tokyo, Japan.

Hiroaki Mitsuya (H)

Department of Refractory Viral Infections, National Center for Global Health and Medicine Research Institute, Tokyo, Japan.

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Classifications MeSH

questionsmedicales.fr › Eucaryotes › Animaux › Chordés › Vertébrés › Mammifères › Eutheria › Primates › Haplorhini › Catarrhini › Hominidae › Humains › Efficacy of convalescent plasma therapy for...
questionsmedicales.fr › Maladies de l'appareil respiratoire › Infections de l'appareil respiratoire › Pneumopathie infectieuse › Pneumopathie virale › COVID-19 › Efficacy of convalescent plasma therapy for...
questionsmedicales.fr › Virus › Virus à ARN › Virus à ARN à brin positif › Nidovirales › Coronaviridae › Coronavirus › Betacoronavirus › Virus du SRAS › SARS-CoV-2 › Efficacy of convalescent plasma therapy for...
questionsmedicales.fr › Régions géographiques › Iles › Japon › Efficacy of convalescent plasma therapy for...
questionsmedicales.fr › Techniques d'investigation › Techniques immunologiques › Immunisation passive › Transfert adoptif › Sérothérapie COVID-19 › Efficacy of convalescent plasma therapy for...
questionsmedicales.fr › Techniques d'investigation › Techniques immunologiques › Immunisation passive › Efficacy of convalescent plasma therapy for...
questionsmedicales.fr › Qualité, accès, évaluation des soins de santé › Qualité des soins de santé › Mécanismes d'évaluation des soins de santé › Évaluation des résultats et des processus en soins de santé › Évaluation de résultat (soins) › Résultat thérapeutique › Efficacy of convalescent plasma therapy for...