Efficacy of convalescent plasma in hospitalized COVID-19 patients: findings from a controlled trial.

IF 1.9 4区 医学 Q2 BIOLOGY Brazilian Journal of Medical and Biological Research Pub Date : 2024-10-07 eCollection Date: 2024-01-01 DOI:10.1590/1414-431X2024e13627
T P Costa, M Aoki, C M Ribeiro, E Socca, L Itinose, R Basso, L Blanes
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Abstract

The COVID-19 pandemic has driven the search for alternative therapies, including convalescent plasma, historically used in infectious diseases. Despite results in other diseases, its effectiveness against COVID-19 remains uncertain with conflicting results in clinical trials. A pragmatic, single-center, prospective, and open randomized controlled trial was carried out in a hospital in Brazil, with the aim of evaluating the impact of convalescent plasma on the clinical improvement of patients hospitalized with COVID-19. The World Health Organization (WHO) ordinal scale was used to measure clinical improvement, focusing on the reduction in disease severity by up to 2 points, while antibody and C-reactive protein levels were monitored over time. After hospital admission, participants were randomized 1:1 to receive convalescent plasma and standard treatment or to be part of the control group with standard treatment. Follow-up was carried out on days 1, 3, 7, 14 and/or at discharge. From January 14 to April 4, 2022, 38 patients were included, but 3 were excluded due to protocol deviations, resulting in a total of 35 patients: 19 in the control group and 16 in the plasma group. There was no significant difference in clinical improvement between the convalescent plasma group and the control group, nor in secondary outcomes. The study had limitations due to the small number of patients and limited representation of COVID-19 cases. Broader investigations are needed to integrate therapies into medical protocols, both for COVID-19 and other diseases. Conducting randomized studies is challenging due to the complexity of medical conditions and the variety of treatments available.

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疗养血浆对 COVID-19 住院患者的疗效:一项对照试验的结果。
COVID-19 大流行促使人们寻找替代疗法,包括历史上用于传染病的康复血浆。尽管在其他疾病中取得了成果,但其对 COVID-19 的疗效仍不确定,临床试验结果也相互矛盾。在巴西的一家医院开展了一项务实、单中心、前瞻性和开放式随机对照试验,旨在评估疗养血浆对改善 COVID-19 住院患者临床症状的影响。该试验采用世界卫生组织(WHO)的顺序量表来衡量临床改善情况,重点是疾病严重程度最多降低 2 个点,同时随时间推移监测抗体和 C 反应蛋白水平。入院后,参与者按 1:1 的比例被随机分配到接受康复血浆和标准治疗组,或接受标准治疗的对照组。在第 1、3、7、14 天和/或出院时进行随访。从 2022 年 1 月 14 日到 4 月 4 日,共纳入 38 名患者,但有 3 名患者因方案偏差而被排除在外,因此共有 35 名患者:对照组 19 人,血浆组 16 人。疗养血浆组与对照组在临床改善和次要结果方面均无明显差异。由于患者人数较少,且 COVID-19 病例的代表性有限,因此该研究存在局限性。需要进行更广泛的调查,以便将治疗方法整合到COVID-19和其他疾病的医疗方案中。由于医疗条件的复杂性和治疗方法的多样性,开展随机研究具有挑战性。
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来源期刊
CiteScore
4.00
自引率
0.00%
发文量
129
审稿时长
2 months
期刊介绍: The Brazilian Journal of Medical and Biological Research, founded by Michel Jamra, is edited and published monthly by the Associação Brasileira de Divulgação Científica (ABDC), a federation of Brazilian scientific societies: - Sociedade Brasileira de Biofísica (SBBf) - Sociedade Brasileira de Farmacologia e Terapêutica Experimental (SBFTE) - Sociedade Brasileira de Fisiologia (SBFis) - Sociedade Brasileira de Imunologia (SBI) - Sociedade Brasileira de Investigação Clínica (SBIC) - Sociedade Brasileira de Neurociências e Comportamento (SBNeC).
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