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An anti-CD6 monoclonal antibody (itolizumab) reduces circulating IL-6 in severe COVID-19 elderly patients
Immunity & Ageing ( IF 7.9 ) Pub Date : 2020-11-14 , DOI: 10.1186/s12979-020-00207-8
Danay Saavedra , Ana Laura Añé-Kourí , Naivy Sánchez , Lázaro Manuel Filgueira , Julio Betancourt , Carlos Herrera , Leniel Manso , Elibet Chávez , Armando Caballero , Carlos Hidalgo , Geydi Lorenzo , Meylan Cepeda , Carmen Valenzuela , Mayra Ramos , Kalet León , Zaima Mazorra , Tania Crombet

Since the COVID-19 outbreak an unprecedented challenge for healthcare systems around the world has been placed. In Cuba, the first case of COVID-19 was reported on March 11. Elderly with multiple comorbidities have been the most risky population. Although most patients present a mild to moderate disease, some have developed severe symptoms. One of the possible mechanisms underlying rapid disease progression is a cytokine storm, in which interleukin (IL) -6 seems to be a major mediator. Itolizumab is a humanized recombinant anti-CD6 monoclonal antibody (MAb), with the ability of reducing serum interferon gamma (INF-γ), tumour necrosis factor alpha (TNFα) and IL-6. Based on these previous results in patients with psoriasis and rheumatoid arthritis, an expanded access clinical trial was approved by the Cuban regulatory agency for COVID-19 critically, severely and moderately ill patients. We show here a short kinetic of IL-6 serum concentration in the first 24 COVID-19 patients treated with itolizumab. Most of patients were elderly with multiple comorbidities. We found that with one itolizumab dose, the circulating IL-6 decreased in critically and severely ill patients, whereas in moderately ill patients the values didn’t rise as compared to their low baseline levels. These findings suggest that itolizumab could be an attractive therapeutic option to decrease the negative outcome of the cytokine storm in COVID-19 patients. CECMED IIC RD-EC 179, RPCEC00000311. Registered 4 May 2020 - Retrospectively registered, http://rpcec.sld.cu/ensayos/RPCEC00000311-Sp or http://rpcec.sld.cu/trials/RPCEC00000311-En

中文翻译:

抗CD6单克隆抗体(itolizumab)降低严重COVID-19老年患者的循环IL-6

自从COVID-19爆发以来,全球医疗系统面临着前所未有的挑战。在古巴,3月11日报告了第一例COVID-19病例。患有多种合并症的老年人是最危险的人群。尽管大多数患者呈现轻度至中度疾病,但有些患者已出现严重症状。疾病快速发展的潜在可能机制之一是细胞因子风暴,其中白介素(IL)-6似乎是主要的介质。Itolizumab是一种人源化重组抗CD6单克隆抗体(MAb),具有降低血清干扰素γ(INF-γ),肿瘤坏死因子α(TNFα)和IL-6的能力。基于先前在银屑病和类风湿性关节炎患者中获得的结果,古巴监管机构严格批准了一项针对COVID-19的扩大准入临床试验,重症和中病患者。我们在这里显示了接受itolizumab治疗的前24例COVID-19患者中IL-6血清浓度的短暂变化。大多数患者是患有多种合并症的老年人。我们发现,使用一种剂量的itolizumab,重症和重症患者的循环IL-6降低,而中度患者与低基线水平相比,其值并未升高。这些发现表明,在降低COVID-19患者中细胞因子风暴的阴性结果方面,阿托珠单抗可能是一种有吸引力的治疗选择。CECMED IIC RD-EC 179,RPCEC00000311。2020年5月4日注册-追溯注册,http://rpcec.sld.cu/ensayos/RPCEC00000311-Sp或http://rpcec.sld.cu/trials/RPCEC00000311-En 我们在这里显示了接受itolizumab治疗的前24例COVID-19患者中IL-6血清浓度的短暂变化。大多数患者是患有多种合并症的老年人。我们发现,使用一种剂量的itolizumab,重症和重症患者的循环IL-6降低,而中度患者与低基线水平相比,其值并未升高。这些发现表明,在降低COVID-19患者中细胞因子风暴的阴性结果方面,阿托珠单抗可能是一种有吸引力的治疗选择。CICMED IIC RD-EC 179,RPCEC00000311。2020年5月4日注册-追溯注册,http://rpcec.sld.cu/ensayos/RPCEC00000311-Sp或http://rpcec.sld.cu/trials/RPCEC00000311-En 我们在这里显示了接受itolizumab治疗的前24例COVID-19患者中IL-6血清浓度的短暂变化。大多数患者是患有多种合并症的老年人。我们发现,使用一种剂量的itolizumab,重症和重症患者的循环IL-6降低,而中度患者与低基线水平相比,其值并未升高。这些发现表明,在降低COVID-19患者中细胞因子风暴的阴性结果方面,阿托珠单抗可能是一种有吸引力的治疗选择。CICMED IIC RD-EC 179,RPCEC00000311。2020年5月4日注册-追溯注册,http://rpcec.sld.cu/ensayos/RPCEC00000311-Sp或http://rpcec.sld.cu/trials/RPCEC00000311-En 我们发现,使用一种剂量的itolizumab,重症和重症患者的循环IL-6降低,而中度患者与低基线水平相比,其值并未升高。这些发现表明,在降低COVID-19患者中细胞因子风暴的阴性结果方面,阿托珠单抗可能是一种有吸引力的治疗选择。CECMED IIC RD-EC 179,RPCEC00000311。2020年5月4日注册-追溯注册,http://rpcec.sld.cu/ensayos/RPCEC00000311-Sp或http://rpcec.sld.cu/trials/RPCEC00000311-En 我们发现,在服用一种单剂量的itolizumab的情况下,危重和重症患者的循环IL-6降低,而中度患者的基线IL-6值却没有升高。这些发现表明,在降低COVID-19患者中细胞因子风暴的阴性结果方面,阿托珠单抗可能是一种有吸引力的治疗选择。CICMED IIC RD-EC 179,RPCEC00000311。2020年5月4日注册-追溯注册,http://rpcec.sld.cu/ensayos/RPCEC00000311-Sp或http://rpcec.sld.cu/trials/RPCEC00000311-En 这些发现表明,在降低COVID-19患者中细胞因子风暴的阴性结果方面,阿托珠单抗可能是一种有吸引力的治疗选择。CICMED IIC RD-EC 179,RPCEC00000311。2020年5月4日注册-追溯注册,http://rpcec.sld.cu/ensayos/RPCEC00000311-Sp或http://rpcec.sld.cu/trials/RPCEC00000311-En 这些发现表明,在降低COVID-19患者中细胞因子风暴的阴性结果方面,阿托珠单抗可能是一种有吸引力的治疗选择。CICMED IIC RD-EC 179,RPCEC00000311。2020年5月4日注册-追溯注册,http://rpcec.sld.cu/ensayos/RPCEC00000311-Sp或http://rpcec.sld.cu/trials/RPCEC00000311-En
更新日期:2020-11-15
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