A two-arm, randomized, controlled, multi-centric, open-label phase-2 study to evaluate the efficacy and safety of Itolizumab in moderate to severe ARDS patients due to COVID-19.
A two-arm, randomized, controlled, multi-centric, open-label phase-2 study to evaluate the efficacy and safety of Itolizumab in moderate to severe ARDS patients due to COVID-19.
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DOI：
10.1080/14712598.2021.1905794
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发表时间：
2021-05
影响因子：
4.6
通讯作者：
Athalye SN
中科院分区：
文献类型：
--
作者：
Kumar S;De Souza R;Nadkar M;Guleria R;Trikha A;Joshi SR;Loganathan S;Vaidyanathan S;Marwah A;Athalye SN
目的：在一项多中心、开放标签、双臂、对照、随机、II期研究中，评价了免疫调节mAb Itolizumab治疗COVID-19患者中因细胞因子释放导致的中重度急性呼吸窘迫综合征（ARDS）的有效性和安全性。方法：患者随机（2：1）分配至A组（最佳支持治疗[BSC]+Itolizumab）和B组（BSC）。关注的主要结局是入组后30天的死亡率降低。结果：筛选了36例患者，其中5例作为首次剂量哨兵治疗，其余患者随机分组，而4例患者筛选失败。A组2例患者在接受一次完整输注前停药，并被替换。1个月结束时，B组有3例死亡，A组无死亡（p = 0.0296; 95% CI =-0.3 [-0.61，-0.08]）。研究结束时，A组中更多患者的SpO 2改善而FiO 2未增加（p = 0.0296），PaO 2改善（p = 0.0296），IL-6（43 vs 212 pg/ml; p = 0.0296）和肿瘤坏死因子-α（9 vs 39 pg/ml; p = 0.0253）水平降低。一过性淋巴细胞减少症（A组：11例患者）和输注反应（7例患者）是常报告的治疗相关安全性事件。结论：Itolizumab是一种有前景、安全有效的免疫调节疗法，用于治疗COVID-19患者因细胞因子释放导致的ARDS，具有生存和恢复获益。
Objective: Efficacy and safety of Itolizumab, an immunomodulatory mAb, in treating moderate-to-severe acute respiratory distress syndrome (ARDS) due to cytokine release in COVID-19 patients was evaluated in a multi-centric, open-label, two-arm, controlled, randomized, phase-2 study. Methods: Patients were randomized (2:1) to Arm-A (best supportive care [BSC]+Itolizumab) and Arm-B (BSC). Primary outcome of interest was reduction in mortality 30-days after enrollment. Results: Thirty-six patients were screened, five treated as first-dose-sentinels and rest randomized, while four patients were screen-failures. Two patients in Arm-A discontinued prior to receiving one complete infusion and were replaced. At end of 1-month, there were three deaths in Arm-B, and none in Arm-A (p = 0.0296; 95% CI = −0.3 [−0.61, −0.08]). At end of study, more patients in Arm-A had improved SpO2 without increasing FiO2 (p = 0.0296), improved PaO2 (p = 0.0296), and reduction in IL-6 (43 vs 212 pg/ml; p = 0.0296) and tumor necrotic factor-α (9 vs 39 pg/ml; p = 0.0253) levels. Transient lymphopenia (Arm-A: 11 patients) and infusion reactions (7 patients) were commonly reported treatment-related safety events. Conclusion: Itolizumab is a promising, safe and effective immunomodulatory therapy for treatment of ARDS due to cytokine release in COVID-19 patients, with survival and recovery-benefit.
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DOI：
10.4103/ijmr.ijmr_2234_20
发表时间：
2020-05
期刊：
The Indian journal of medical research
影响因子：
--
作者：
Chatterjee P;Anand T;Singh KJ;Rasaily R;Singh R;Das S;Singh H;Praharaj I;Gangakhedkar RR;Bhargava B;Panda S
通讯作者：
Panda S
影响因子：
3.7
作者：
Bughani U;Saha A;Kuriakose A;Nair R;Sadashivarao RB;Venkataraman R;Patel S;Deshchougule AT;S SK;Montero E;Pai HV;Palanivelu DV;Melarkode R;Nair P
通讯作者：
Nair P
DOI：
10.1186/s12941-020-00362-2
发表时间：
2020-05-15
影响因子：
5.7
作者：
Chen, Wei;Zheng, Kenneth I.;Qiao, Zengpei
通讯作者：
Qiao, Zengpei
影响因子：
158.5
作者：
Boulware, David R.;Pullen, Matthew F.;Hullsiek, Kathy H.
通讯作者：
Hullsiek, Kathy H.
影响因子：
3.4
作者：
Chopra, Arvind;Chandrashekara, S.;Montero, Enrique
通讯作者：
Montero, Enrique