Prediction of Survival by IL-6 in a Randomized Placebo-Controlled Trial of Anakinra in COVID-19 Cytokine Storm.
Prediction of Survival by IL-6 in a Randomized Placebo-Controlled Trial of Anakinra in COVID-19 Cytokine Storm.
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DOI：
10.3390/v15102036
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发表时间：
2023-09-30
期刊：
影响因子：
--
通讯作者：
Chatham WW
中科院分区：
文献类型：
--
作者：
Jackson LE;Khullar N;Beukelman T;Chapleau C;Kamath A;Cron RQ;Chatham WW
(1)背景：一些重症COVID-19患者出现高炎症细胞因子风暴综合征（CSS）。我们评估了阿那白滞素添加到护理标准 (SoC) 中对住院的 COVID-19 CSS 患者的疗效。 （2）方法：在这项单中心、随机、双盲、安慰剂对照试验（NCT04362111）中，我们招募了患有 SARS-CoV-2 感染、有肺炎证据、新的/增加的需氧量、铁蛋白≥ 700 ng/mL、且至少有以下指标中的三个的成年住院患者：D-二聚体≥ 500 ng/mL、血小板计数< 130,000/mm3、WBC < 3500/mm3 或淋巴细胞计数 < 1000/mm3、AST 或 ALT > 2X 正常上限 (ULN)、LDH > 2X ULN、C 反应蛋白 > 100 mg/L。患者被随机 (1:1) 接受 SoC 加阿那白滞素组（每 6 小时皮下注射 100 毫克，持续 10 天）或安慰剂组。所有人都接受了地塞米松治疗。主要结局是生存和出院，无需插管/机械通气。根据修改后的意向治疗方法对数据进行分析。 （3）结果：2020年8月至2021年1月期间，招募了32名患者，其中15名分配至阿那白滞素组，17名分配至安慰剂组。两名接受安慰剂的患者在 48 小时内退出并被排除。平均年龄为 63 岁 (SD 10.3)，20 名患者 (67%) 为男性，20 名患者 (67%) 为白人。第 10 天，一名 (7%) 接受阿那白滞素治疗的患者和两名 (13%) 接受安慰剂的患者死亡 (p = 1.0)。出院时，四名（27%）接受阿那白滞素治疗的患者和四名（27%）接受安慰剂的患者死亡。入组时的 IL-6 水平可预测死亡 (p < 0.01)；阿那白滞素的使用与 CXCL9 水平降低相关。 (4)结论：阿那白滞素联合地塞米松并未显着影响患有CSS的COVID-19肺炎患者的生存。需要进行更多研究来评估患者选择以及阿那白滞素治疗 COVID-19 CSS 的疗效、时机和持续时间。
(1) Background: Some severe COVID-19 patients develop hyperinflammatory cytokine storm syndrome (CSS). We assessed the efficacy of anakinra added to standard of care (SoC) in hospitalized COVID-19 CSS patients. (2) Methods: In this single-center, randomized, double-blind, placebo-controlled trial (NCT04362111), we recruited adult hospitalized patients with SARS-CoV-2 infection, evidence of pneumonia, new/increasing oxygen requirement, ferritin ≥ 700 ng/mL, and at least three of the following indicators: D-dimer ≥ 500 ng/mL, platelet count < 130,000/mm3, WBC < 3500/mm3 or lymphocyte count < 1000/mm3, AST or ALT > 2X the upper limit of normal (ULN), LDH > 2X ULN, C-reactive protein > 100 mg/L. Patients were randomized (1:1) to SoC plus anakinra (100 mg subcutaneously every 6 h for 10 days) or placebo. All received dexamethasone. The primary outcome was survival and hospital discharge without need for intubation/mechanical ventilation. The data were analyzed according to the modified intention-to-treat approach. (3) Results: Between August 2020 and January 2021, 32 patients were recruited, of which 15 were assigned to the anakinra group, and 17 to the placebo group. Two patients receiving the placebo withdrew within 48 h and were excluded. The mean age was 63 years (SD 10.3), 20 (67%) patients were men, and 20 (67%) were White. At Day 10, one (7%) patient receiving anakinra and two (13%) patients receiving the placebo had died (p = 1.0). At hospital discharge, four (27%) patients receiving anakinra and four (27%) patients receiving the placebo had died. The IL-6 level at enrollment was predictive of death (p < 0.01); anakinra use was associated with decreases in CXCL9 levels. (4) Conclusions: Anakinra added to dexamethasone did not significantly impact the survival of COVID-19 pneumonia patients with CSS. Additional studies are needed to assess patient selection and the efficacy, timing, and duration of anakinra treatment for COVID-19 CSS.
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DOI：
10.1016/j.ijid.2020.11.149
发表时间：
2021-03
期刊：
International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases
影响因子：
--
作者：
Balkhair A;Al-Zakwani I;Al Busaidi M;Al-Khirbash A;Al Mubaihsi S;BaTaher H;Al Aghbari J;Al Busaidi I;Al Kindi M;Baawain S;Al Alawi A;Al Lawati A;Al Rawahi B;Al-Baimani K;Al Zidi K;Elfatih N;Dawud B;John B;Rehman F;Yousif F;Al Khadouri G;Saber I;Lal J;Gargouri M;Al-Ward M;AbuDraz N;Al Ruqeishi S;Kumar S;Abdelmottaleb W;Al-Naamani Z;Bin Nazar Z;Balkhair O
通讯作者：
Balkhair O
DOI：
10.1016/s2665-9913(21)00353-2
发表时间：
2022-01
期刊：
The Lancet. Rheumatology
影响因子：
--
作者：
Kelmenson DA;Cron RQ
通讯作者：
Cron RQ
影响因子：
8.8
作者：
Shakoory B;Carcillo JA;Chatham WW;Amdur RL;Zhao H;Dinarello CA;Cron RQ;Opal SM
通讯作者：
Opal SM
DOI：
10.1016/j.jaci.2020.11.006
发表时间：
2021-03
期刊：
The Journal of allergy and clinical immunology
影响因子：
--
作者：
Bozzi G;Mangioni D;Minoia F;Aliberti S;Grasselli G;Barbetta L;Castelli V;Palomba E;Alagna L;Lombardi A;Ungaro R;Agostoni C;Baldini M;Blasi F;Cesari M;Costantino G;Fracanzani AL;Montano N;Monzani V;Pesenti A;Peyvandi F;Sottocorno M;Muscatello A;Filocamo G;Gori A;Bandera A
通讯作者：
Bandera A
影响因子：
8.4
作者：
Langer-Gould, Annette;Smith, Jessica B.;Gould, Michael K.
通讯作者：
Gould, Michael K.