Hyperinflammation distinguishes COVID-19 patients who develop a slight disease or none, from those progressing to severe and critical conditions. CIGB-258 is a therapeutic option for the latter group of patients. This drug is an altered peptide ligand (APL) derived from the cellular stress protein 60 (HSP60). In preclinical models, this peptide developed anti-inflammatory effects and increased regulatory T cell (Treg) activity. Results from a phase I clinical trial with rheumatoid arthritis (RA) patients indicated that CIGB-258 was safe and reduced inflammation. The aim of this study was to examine specific biomarkers associated with hyperinflammation, some cytokines linked to the cytokine storm granzyme B and perforin in a cohort of COVID-19 patients treated with this peptide. All critically ill patients were under invasive mechanical ventilation and received the intravenous administration of 1 or 2 mg of CIGB-258 every 12 h. Seriously ill patients were treated with oxygen therapy receiving 1 mg of CIGB-258 every 12 h and all patients recovered from their severe condition. Biomarker levels associated with hyperinflammation, such as interleukin (IL)-6, IL-10, tumor necrosis factor (TNF-α), granzyme B, and perforin, significantly decreased during treatment. Furthermore, we studied the ability of CIGB-258 to induce Tregs in COVID-19 patients and found that Tregs were induced in all patients studied. Altogether, these results support the therapeutic potential of CIGB-258 for diseases associated with hyperinflammation. Clinical trial registry: RPCEC00000313

过度炎症将出现轻微疾病或无疾病的 COVID-19 患者与进展为严重和危重症的患者区分开来。 CIGB-258是后一组患者的治疗选择。该药物是一种源自细胞应激蛋白 60 (HSP60) 的改变肽配体 (APL)。在临床前模型中，这种肽具有抗炎作用并增加调节性 T 细胞 (Treg) 活性。类风湿性关节炎 (RA) 患者的 I 期临床试验结果表明 CIGB-258 是安全的，并且可以减少炎症。本研究的目的是在接受该肽治疗的一组 COVID-19 患者中检查与过度炎症相关的特定生物标志物、与细胞因子风暴颗粒酶 B 和穿孔素相关的一些细胞因子。所有危重患者均接受有创机械通气，每12小时静脉注射1或2 mg CIGB-258。重症患者接受氧疗，每12小时接受1毫克CIGB-258，所有患者均从重症中康复。与过度炎症相关的生物标志物水平，如白细胞介素 (IL)-6、IL-10、肿瘤坏死因子 (TNF-α)、颗粒酶 B 和穿孔素，在治疗期间显着降低。此外，我们研究了 CIGB-258 在 COVID-19 患者中诱导 Tregs 的能力，发现所有研究的患者中都诱导了 Tregs。总而言之，这些结果支持 CIGB-258 对于与过度炎症相关的疾病的治疗潜力。临床试验注册：RPCEC00000313