Background 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. Results 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. Conclusion These findings suggest that itolizumab could be an attractive therapeutic option to decrease the negative outcome of the cytokine storm in COVID-19 patients. Trial registration 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
【저자키워드】 COVID-19, IL-6, itolizumab, Cytokine release syndrome, 【초록키워드】 Necrosis, Cytokine storm, clinical trial, elderly, monoclonal antibody, outcome, rheumatoid arthritis, Regulatory, Disease progression, serum, COVID-19 outbreak, Patient, Mild, Alpha, mechanism, COVID-19 patients, interferon gamma, Concentration, dose, COVID-19 patient, kinetic, Healthcare system, INF-γ, therapeutic option, moderate disease, severe symptoms, Registered, TNFα, circulating, baseline levels, severely ill patients, agency, multiple comorbidities, Cuba, MOST, humanized, decrease, Result, reported, approved, treated, reducing, ill patient, ill patients, multiple comorbidity, the cytokine storm, 【제목키워드】 severe COVID-19, monoclonal antibody, Elderly patient, circulating, reduce,