Alice T W Song, Vanderson Rocha, Alfredo Mendrone-Júnior, Rodrigo T Calado, Gil C De Santis, Bruno D Benites, Carolina Costa-Lima, Taiani Vargas, Leonardo S Marques, Juliana C Fernandes, Felipe C Breda, Silvano Wendel, Roberta Fachini, Luiz V Rizzo, José Mauro Kutner, Vivian I Avelino-Silva, Rafael R G Machado, Edison L Durigon, Sylvie Chevret, Esper G Kallas
{"title":"用低容量或高容量复原血浆治疗重症 COVID-19 患者与标准护理相比：多中心贝叶斯随机开放标签临床试验（COOP-COVID-19-MCTI）。","authors":"Alice T W Song, Vanderson Rocha, Alfredo Mendrone-Júnior, Rodrigo T Calado, Gil C De Santis, Bruno D Benites, Carolina Costa-Lima, Taiani Vargas, Leonardo S Marques, Juliana C Fernandes, Felipe C Breda, Silvano Wendel, Roberta Fachini, Luiz V Rizzo, José Mauro Kutner, Vivian I Avelino-Silva, Rafael R G Machado, Edison L Durigon, Sylvie Chevret, Esper G Kallas","doi":"10.1016/j.lana.2022.100216","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Administration of convalescent plasma may serve as an adjunct to supportive treatment to prevent COVID-19 progression and death. We aimed to evaluate the efficacy and safety of 2 volumes of intravenous convalescent plasma (CP) with high antibody titers for the treatment of severe cases of COVID-19.</p><p><strong>Methods: </strong>We conducted a Bayesian, randomized, open-label, multicenter, controlled clinical trial in 7 Brazilian hospitals. Adults admitted to hospital with positive RT-PCR for SARS-CoV2, within 10 days of the symptom onset, were eligible. Patients were randomly assigned (1:1:1) to receive standard of care (SoC) alone, or in combination with 200 mL (150-300 mL) of CP (Low-volume), or 400 mL (300-600 mL) of CP (High-volume); infusion had to be performed within 24 h of randomization. Randomization was centralized, stratified by center. The primary outcome was the time until clinical improvement up to day 28, measured by the WHO ten-point scale, assessed in the intention-to-treat population. Interim and terminal analyses were performed in a Bayesian framework. Trial registered at ClinicalTrials.gov: NCT04415086.</p><p><strong>Findings: </strong>Between June 2, 2020, and November 18, 2020, 129 patients were enrolled and randomly assigned to SoC (<i>n</i> = 42), Low-volume (<i>n</i> = 43) or High-volume (<i>n</i> = 44) CP. Donors presented a median titer of neutralizing antibodies of 1:320 (interquartile range, 1:160 to 1:1088). No evidence of any benefit of convalescent plasma was observed, with Bayesian estimate of 28-day clinical improvement of 72.7% (95%CI, 58.8 to 84.7) in the SoC versus 64.1% (95%ci, 53.8 to 73.7) in the pooled experimental groups (mean difference of -8.7%, 95%CI, -24.6 to 8.2). There was one case of cutaneous mild allergic reaction related to plasma transfusion and one case of suspected transfusion-related acute lung injury but deemed not to be related to convalescent plasma infusion.</p><p><strong>Interpretation: </strong>In this prospective, randomized trial of adult hospitalized patients with severe COVID-19, convalescent plasma was not associated with clinical benefits.</p><p><strong>Funding: </strong>Brazilian Ministry of Science, Technology and Innovation, Fundação de Amparo à Pesquisa do Estado de São Paulo.</p>","PeriodicalId":15836,"journal":{"name":"Journal of Geophysical Research","volume":"84 1","pages":"100216"},"PeriodicalIF":0.0000,"publicationDate":"2022-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8923059/pdf/","citationCount":"0","resultStr":"{\"title\":\"Treatment of severe COVID-19 patients with either low- or high-volume of convalescent plasma <i>versus</i> standard of care: A multicenter Bayesian randomized open-label clinical trial (COOP-COVID-19-MCTI).\",\"authors\":\"Alice T W Song, Vanderson Rocha, Alfredo Mendrone-Júnior, Rodrigo T Calado, Gil C De Santis, Bruno D Benites, Carolina Costa-Lima, Taiani Vargas, Leonardo S Marques, Juliana C Fernandes, Felipe C Breda, Silvano Wendel, Roberta Fachini, Luiz V Rizzo, José Mauro Kutner, Vivian I Avelino-Silva, Rafael R G Machado, Edison L Durigon, Sylvie Chevret, Esper G Kallas\",\"doi\":\"10.1016/j.lana.2022.100216\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>Administration of convalescent plasma may serve as an adjunct to supportive treatment to prevent COVID-19 progression and death. We aimed to evaluate the efficacy and safety of 2 volumes of intravenous convalescent plasma (CP) with high antibody titers for the treatment of severe cases of COVID-19.</p><p><strong>Methods: </strong>We conducted a Bayesian, randomized, open-label, multicenter, controlled clinical trial in 7 Brazilian hospitals. Adults admitted to hospital with positive RT-PCR for SARS-CoV2, within 10 days of the symptom onset, were eligible. Patients were randomly assigned (1:1:1) to receive standard of care (SoC) alone, or in combination with 200 mL (150-300 mL) of CP (Low-volume), or 400 mL (300-600 mL) of CP (High-volume); infusion had to be performed within 24 h of randomization. Randomization was centralized, stratified by center. The primary outcome was the time until clinical improvement up to day 28, measured by the WHO ten-point scale, assessed in the intention-to-treat population. Interim and terminal analyses were performed in a Bayesian framework. Trial registered at ClinicalTrials.gov: NCT04415086.</p><p><strong>Findings: </strong>Between June 2, 2020, and November 18, 2020, 129 patients were enrolled and randomly assigned to SoC (<i>n</i> = 42), Low-volume (<i>n</i> = 43) or High-volume (<i>n</i> = 44) CP. Donors presented a median titer of neutralizing antibodies of 1:320 (interquartile range, 1:160 to 1:1088). No evidence of any benefit of convalescent plasma was observed, with Bayesian estimate of 28-day clinical improvement of 72.7% (95%CI, 58.8 to 84.7) in the SoC versus 64.1% (95%ci, 53.8 to 73.7) in the pooled experimental groups (mean difference of -8.7%, 95%CI, -24.6 to 8.2). There was one case of cutaneous mild allergic reaction related to plasma transfusion and one case of suspected transfusion-related acute lung injury but deemed not to be related to convalescent plasma infusion.</p><p><strong>Interpretation: </strong>In this prospective, randomized trial of adult hospitalized patients with severe COVID-19, convalescent plasma was not associated with clinical benefits.</p><p><strong>Funding: </strong>Brazilian Ministry of Science, Technology and Innovation, Fundação de Amparo à Pesquisa do Estado de São Paulo.</p>\",\"PeriodicalId\":15836,\"journal\":{\"name\":\"Journal of Geophysical Research\",\"volume\":\"84 1\",\"pages\":\"100216\"},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2022-06-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8923059/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Journal of Geophysical Research\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.1016/j.lana.2022.100216\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2022/3/15 0:00:00\",\"PubModel\":\"Epub\",\"JCR\":\"Q1\",\"JCRName\":\"Earth and Planetary Sciences\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of Geophysical Research","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.1016/j.lana.2022.100216","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2022/3/15 0:00:00","PubModel":"Epub","JCR":"Q1","JCRName":"Earth and Planetary Sciences","Score":null,"Total":0}
Treatment of severe COVID-19 patients with either low- or high-volume of convalescent plasma versus standard of care: A multicenter Bayesian randomized open-label clinical trial (COOP-COVID-19-MCTI).
Background: Administration of convalescent plasma may serve as an adjunct to supportive treatment to prevent COVID-19 progression and death. We aimed to evaluate the efficacy and safety of 2 volumes of intravenous convalescent plasma (CP) with high antibody titers for the treatment of severe cases of COVID-19.
Methods: We conducted a Bayesian, randomized, open-label, multicenter, controlled clinical trial in 7 Brazilian hospitals. Adults admitted to hospital with positive RT-PCR for SARS-CoV2, within 10 days of the symptom onset, were eligible. Patients were randomly assigned (1:1:1) to receive standard of care (SoC) alone, or in combination with 200 mL (150-300 mL) of CP (Low-volume), or 400 mL (300-600 mL) of CP (High-volume); infusion had to be performed within 24 h of randomization. Randomization was centralized, stratified by center. The primary outcome was the time until clinical improvement up to day 28, measured by the WHO ten-point scale, assessed in the intention-to-treat population. Interim and terminal analyses were performed in a Bayesian framework. Trial registered at ClinicalTrials.gov: NCT04415086.
Findings: Between June 2, 2020, and November 18, 2020, 129 patients were enrolled and randomly assigned to SoC (n = 42), Low-volume (n = 43) or High-volume (n = 44) CP. Donors presented a median titer of neutralizing antibodies of 1:320 (interquartile range, 1:160 to 1:1088). No evidence of any benefit of convalescent plasma was observed, with Bayesian estimate of 28-day clinical improvement of 72.7% (95%CI, 58.8 to 84.7) in the SoC versus 64.1% (95%ci, 53.8 to 73.7) in the pooled experimental groups (mean difference of -8.7%, 95%CI, -24.6 to 8.2). There was one case of cutaneous mild allergic reaction related to plasma transfusion and one case of suspected transfusion-related acute lung injury but deemed not to be related to convalescent plasma infusion.
Interpretation: In this prospective, randomized trial of adult hospitalized patients with severe COVID-19, convalescent plasma was not associated with clinical benefits.
Funding: Brazilian Ministry of Science, Technology and Innovation, Fundação de Amparo à Pesquisa do Estado de São Paulo.
期刊介绍：
Journal of Geophysical Research (JGR) publishes original scientific research on the physical, chemical, and biological processes that contribute to the understanding of the Earth, Sun, and solar system and all of their environments and components. JGR is currently organized into seven disciplinary sections (Atmospheres, Biogeosciences, Earth Surface, Oceans, Planets, Solid Earth, Space Physics). Sections may be added or combined in response to changes in the science.
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