Department of Pathology and Laboratory Medicine, University of Arkansas for Medical Sciences, Little Rock, AR, USA.
Oklahoma/Texas/and Arkansas Blood Institute, Oklahoma City, OK, USA.
Lab Med. 2022 Nov 3;53(6):623-628. doi: 10.1093/labmed/lmac055.
Many therapies are used to treat COVID-19, the disease caused by the virus SARS-CoV-2, including convalescent plasma. The clinical utility of using 2 units of convalescent plasma for COVID-19 hospitalized patients is not fully understood.
Many therapies are used to treat COVID-19, the disease caused by the virus SARS-CoV-2, including convalescent plasma. The clinical utility of using 2 units of convalescent plasma for COVID-19 hospitalized patients is not fully understood. Our study aims to determine the safety and efficacy of treating hospitalized COVID-19 patients with 2 units of COVID-19 convalescent plasma (CCP).
This was a retrospective study of Arkansas patients treated with CCP using the (US) Food and Drug Administration (FDA) emergency Investigational New Drug (eIND) mechanism from April 9, 2020, through August 9, 2020. It was a multicenter, statewide study in a low-resource setting, which are areas that lack funding for health care cost coverage on various levels including individual, family, or social. Adult patients (n = 165, volunteer sample) in Arkansas who were hospitalized with severe or life-threatening acute COVID-19 disease as defined by the FDA criteria were transfused with 2 units of CCP (250 mL/unit) using the FDA eIND mechanism. The primary outcome was 7- and 30-day mortality after the second unit of CCP.
Unadjusted mortality was 12.1% at 7 days and 23.0% at 30 days. The unadjusted mortality was reduced to 7.7% if the first CCP unit was transfused on the date of diagnosis, 8.7% if transfused within 3 days of diagnosis, and 32.0% if transfused at or after 4 or more days of diagnosis. The risk of death was higher in patients that received low, negative, or missing titer CCP units in comparison to those that received higher titer units.
The provision of 2 units of CCP was associated with a reduction in mortality in patients treated with high titer units within 3 days of COVID-19 diagnosis. Given the results, CCP is a viable, low-cost therapy in resource-constrained states and countries.
许多疗法被用于治疗由病毒 SARS-CoV-2 引起的 COVID-19 疾病,包括恢复期血浆。对于 COVID-19 住院患者使用 2 单位恢复期血浆的临床效果尚未完全了解。
许多疗法被用于治疗由病毒 SARS-CoV-2 引起的 COVID-19 疾病,包括恢复期血浆。对于 COVID-19 住院患者使用 2 单位恢复期血浆的临床效果尚未完全了解。我们的研究旨在确定使用 2 单位 COVID-19 恢复期血浆(CCP)治疗 COVID-19 住院患者的安全性和有效性。
这是一项回顾性研究,纳入了 2020 年 4 月 9 日至 2020 年 8 月 9 日期间使用美国食品和药物管理局(FDA)紧急研究新药(eIND)机制接受 CCP 治疗的阿肯色州患者。这是一项多中心、全州范围的研究,处于医疗保健费用覆盖在个人、家庭或社会各级缺乏资金的低资源环境中。阿肯色州的成年患者(n=165,志愿者样本)符合 FDA 标准定义的患有严重或危及生命的急性 COVID-19 疾病,使用 FDA eIND 机制输注 2 单位 CCP(250 mL/单位)。主要结局是第二单位 CCP 后 7 天和 30 天的死亡率。
未调整的 7 天死亡率为 12.1%,30 天死亡率为 23.0%。如果第一单位 CCP 在诊断日输注、在诊断后 3 天内输注或在诊断后 4 天或更长时间内输注,未调整的死亡率分别降低至 7.7%、8.7%和 32.0%。与接受高滴度单位 CCP 的患者相比,接受低滴度、阴性或缺失滴度 CCP 单位的患者死亡风险更高。
在 COVID-19 诊断后 3 天内接受高滴度单位 CCP 的患者中,提供 2 单位 CCP 与死亡率降低相关。鉴于这些结果,CCP 是资源有限的州和国家可行的、低成本的治疗方法。