Objectives

Cytokine release syndrome (CRS) is a potentially severe complication of COVID-19 most commonly resulting in respiratory failure. This ten-patient study was designed to determine the efficacy of therapeutic plasma exchange (TPE) in improving oxygenation and in reducing the cytokine load in a critically ill subset of patients.

Methods

Five single volume plasma exchanges over eight days within a 14-day study period. In mechanically ventilated patients, oxygenation was measured via the PaO2/FiO2 (P/F) ratio and the oxygenation index (OI) daily for 14 days. Supplemental oxygen requirements were tracked daily for non-ventilated patients.

Results

Non-ventilated patients were liberated from supplemental oxygen after TPE. The response was rapid with an 87% average reduction in oxygenation requirements following and average time to return to room air of 5.25 days. All mechanically ventilated patients demonstrated improvement in oxygenation with a 78% average improvement in the P/F ratio and a 43% improvement in OI. C-reactive protein (CRP) and serum levels of IL-6, IL-8, IL-10, TNFα, IFNγ and GM-CSF, were measured daily with immediate post TPE levels drawn on days 1, 2, 4, 6 and 8. All patients demonstrated significant reductions in CRP, IL-6, IL-10 and TNFα.

Conclusions

In the majority of patients with Penn class 3 and 4 CRS complicating COVID-19, TPE demonstrated a prompt improvement in oxygenation and reduction in cytokine load without compromising patient safety. As this pilot study was envisioned to be hypothesis generating, expanded trials using TPE alone and in conjunction with novel pharmacologic agents are warranted.

Registration

ClinicalTrials.gov NCT04374149.

中文翻译：

---

治疗性血浆置换治疗并发 COVID-19 的 Penn 3 类和 4 类细胞因子释放综合征的疗效

目标

细胞因子释放综合征 (CRS) 是 COVID-19 的一种潜在严重并发症，最常导致呼吸衰竭。这项包含 10 名患者的研究旨在确定治疗性血浆置换 (TPE) 在改善氧合作用和减少危重患者亚组细胞因子负荷方面的功效。

方法

在 14 天的研究期内，在八天内进行了五次单体积血浆交换。在机械通气患者中，每天通过 PaO2/FiO2 (P/F) 比率和氧合指数 (OI) 测量氧合情况，持续 14 天。每天跟踪非通气患者的补充氧气需求。

结果

非通气患者在 TPE 后从补充氧气中解放出来。反应迅速，氧合需求平均减少 87%，恢复室内空气的平均时间为 5.25 天。所有机械通气患者均表现出氧合改善，P/F 比平均改善 78%，OI 改善 43%。每天测量 C 反应蛋白 (CRP) 和血清 IL-6、IL-8、IL-10、TNFα、IFNγ 和 GM-CSF 水平，并在第 1、2、4、6 天和8. 所有患者均表现出 CRP、IL-6、IL-10 和 TNFα 的显着降低。

结论

在大多数患有 Penn 3 级和 4 级 CRS 并发 COVID-19 的患者中，TPE 显示出在不损害患者安全的情况下迅速改善氧合和减少细胞因子负荷。由于该初步研究被设想为产生假设，因此有必要扩大单独使用 TPE 并与新型药物结合使用的试验。

登记

ClinicalTrials.gov NCT04374149。