Kurtz Pedro, Righy Cassia, Gadelha Monica, Bozza Fernando A, Bozza Patricia T, Gonçalves Bruno, Bastos Leonardo S L, Vale Andre M, Higa Luiza M, Castilho Leda, Monteiro Fabio L, Charris Nestor, Fialho Fernanda, Turon Ricardo, Guterres Alexandro, Lyra Miranda Renan, de Azeredo Lima Carlos Henrique, de Caro Vanessa, Prazeres Marco Aurelio, Ventura Nina, Gaspari Clara, Miranda Fabio, Jose da Mata Paulo, Pêcego Margarida, Mateos Sheila, Lopes Maria Esther, Castilho Shirley, Oliveira Álvaro, Boquimpani Carla, Rabello Andréa, Lopes Josiane, Neto Orlando Conceição, Ferreira Orlando da C, Tanuri Amilcar, Filho Paulo Niemeyer, Amorim Luiz
Instituto Estadual do Cérebro Paulo Niemeyer, Rio de Janeiro, Brazil.
D'Or Institute for Research and Education, Rio de Janeiro, Brazil.
Front Med (Lausanne). 2021 Jan 28;8:630982. doi: 10.3389/fmed.2021.630982. eCollection 2021.
Convalescent plasma is a potential therapeutic option for critically ill patients with coronavirus disease 19 (COVID-19), yet its efficacy remains to be determined. The aim was to investigate the effects of convalescent plasma (CP) in critically ill patients with COVID-19. This was a single-center prospective observational study conducted in Rio de Janeiro, Brazil, from March 17th to May 30th, with final follow-up on June 30th. We included 113 laboratory-confirmed COVID-19 patients with respiratory failure. Primary outcomes were time to clinical improvement and survival within 28 days. Secondary outcomes included behavior of biomarkers and viral loads. Kaplan-Meier analyses and Cox proportional-hazards regression using propensity score with inverse-probability weighing were performed. 41 patients received CP and 72 received standard of care (SOC). Median age was 61 years (IQR 48-68), disease duration was 10 days (IQR 6-13), and 86% were mechanically ventilated. At least 29 out of 41CP-recipients had baseline IgG titers ≥ 1:1,080. Clinical improvement within 28 days occurred in 19 (46%) CP-treated patients, as compared to 23 (32%) in the SOC group [adjusted hazard ratio (aHR) 0.91 (0.49-1.69)]. There was no significant change in 28-day mortality (CP 49% vs. SOC 56%; aHR 0.90 [0.52-1.57]). Biomarker assessment revealed reduced inflammatory activity and increased lymphocyte count after CP. In this study, CP was not associated with clinical improvement or increase in 28-day survival. However, our study may have been underpowered and included patients with high IgG titers and life-threatening disease. The study protocol was retrospectively registered at the Brazilian Registry of Clinical Trials (ReBEC) with the identification RBR-4vm3yy (http://www.ensaiosclinicos.gov.br).
康复期血浆是新型冠状病毒肺炎（COVID-19）重症患者的一种潜在治疗选择，但其疗效仍有待确定。目的是研究康复期血浆（CP）对COVID-19重症患者的影响。这是一项于3月17日至5月30日在巴西里约热内卢进行的单中心前瞻性观察性研究，最终随访于6月30日进行。我们纳入了113例实验室确诊的COVID-19呼吸衰竭患者。主要结局是临床改善时间和28天内的生存率。次要结局包括生物标志物和病毒载量的变化。采用倾向评分逆概率加权法进行Kaplan-Meier分析和Cox比例风险回归分析。41例患者接受了CP治疗，72例接受了标准治疗（SOC）。中位年龄为61岁（四分位间距48-68岁），病程为10天（四分位间距6-13天），86%的患者接受了机械通气。41例接受CP治疗的患者中至少有29例基线IgG滴度≥1:1080。28天内，19例（46%）接受CP治疗的患者出现临床改善，而SOC组为23例（32%）[调整后风险比（aHR）0.91（0.49-1.69）]。28天死亡率无显著变化（CP组为49%，SOC组为56%；aHR 0.90[0.52-1.57]）。生物标志物评估显示，CP治疗后炎症活性降低，淋巴细胞计数增加。在本研究中，CP与临床改善或28天生存率提高无关。然而，我们的研究可能效力不足，且纳入了高IgG滴度和危及生命疾病的患者。该研究方案已在巴西临床试验注册中心（ReBEC）进行回顾性注册，识别号为RBR-4vm3yy（http://www.ensaiosclinicos.gov.br）。
