Infectious Disease & Beleghata General Hospital, Kolkata, India.
Department of Tropical Medicine, School of Tropical Medicine, Kolkata, India.
Nat Commun. 2022 Jan 19;13(1):383. doi: 10.1038/s41467-022-28064-7.
A single center open label phase 2 randomised control trial (Clinical Trial Registry of India No. CTRI/2020/05/025209) was done to assess clinical and immunological benefits of passive immunization using convalescent plasma therapy. At the Infectious Diseases and Beleghata General Hospital in Kolkata, India, 80 patients hospitalized with severe COVID-19 disease and fulfilling the inclusion criteria (aged more than 18 years, with either mild ARDS having PaO2/FiO2 200-300 or moderate ARDS having PaO2/FiO2 100-200, not on mechanical ventilation) were recruited and randomized into either standard of care (SOC) arm (N = 40) or the convalescent plasma therapy (CPT) arm (N = 40). Primary outcomes were all-cause mortality by day 30 of enrolment and immunological correlates of response to therapy if any, for which plasma abundance of a large panel of cytokines was quantitated before and after intervention to assess the effect of CPT on the systemic hyper-inflammation encountered in these patients. The secondary outcomes were recovery from ARDS and time taken to negative viral RNA PCR as well as to report any adverse reaction to plasma therapy. Transfused convalescent plasma was characterized in terms of its neutralizing antibody content as well as proteome. The trial was completed and it was found that primary outcome of all-cause mortality was not significantly different among severe COVID-19 patients with ARDS randomized to two treatment arms (Mantel-Haenszel Hazard Ratio 0.6731, 95% confidence interval 0.3010-1.505, with a P value of 0.3424 on Mantel-Cox Log-rank test). No adverse effect was reported with CPT. In severe COVID-19 patients with mild or moderate ARDS no significant clinical benefit was registered in this clinical trial with convalescent plasma therapy in terms of prespecified outcomes.
一项单中心、开放性标签的 2 期随机对照试验（印度临床试验注册中心编号 CTRI/2020/05/025209）旨在评估使用恢复期血浆疗法进行被动免疫的临床和免疫获益。在印度加尔各答的传染病和贝莱加塔综合医院，招募了 80 名患有严重 COVID-19 疾病并符合纳入标准（年龄大于 18 岁，轻度 ARDS 患者的 PaO2/FiO2 为 200-300，中度 ARDS 患者的 PaO2/FiO2 为 100-200，未接受机械通气）的住院患者，并将其随机分为标准治疗（SOC）组（N=40）或恢复期血浆治疗（CPT）组（N=40）。主要结局是入组后第 30 天的全因死亡率，以及如果有任何免疫相关的治疗反应，通过在干预前后定量检测大量细胞因子的血浆丰度来评估 CPT 对这些患者全身炎症反应的影响。次要结局是 ARDS 的恢复以及病毒 RNA PCR 转为阴性所需的时间，以及报告任何对血浆治疗的不良反应。输注的恢复期血浆在其中和抗体含量和蛋白质组方面进行了特征描述。该试验已经完成，结果发现，随机分为两个治疗组的 ARDS 严重 COVID-19 患者的全因死亡率主要结局无显著差异（Mantel-Haenszel 危害比 0.6731，95%置信区间 0.3010-1.505，Mantel-Cox 对数秩检验的 P 值为 0.3424）。CPT 未报告不良反应。在轻度或中度 ARDS 的严重 COVID-19 患者中，在该临床试验中，恢复期血浆治疗在预定结局方面未显示出显著的临床获益。
