PMC:7784786 / 13157-16527
Annnotations
{"target":"https://pubannotation.org/docs/sourcedb/PMC/sourceid/7784786","sourcedb":"PMC","sourceid":"7784786","source_url":"https://www.ncbi.nlm.nih.gov/pmc/7784786","text":"Discussion\nCRS is characterized by high levels of inflammatory cytokines. Among them, IL-6 is considered a major mediator of this hyperinflammation [18,19]. Most of the COVID-19 patients-related papers showed the CRS as one of the main hallmark of the disease [20]. Additionally, IL-6 levels predict severity in COVID-19 patients [21]. There is high heterogeneity of IL-6 values among papers for classifying severe and nonsevere patients. In a large meta-analysis of 52 manuscripts, Elshazli and coworkers found that the IL-6 level associated with COVID-19 severity was 22.9 pg/ml [22]. In a series of patients treated with itolizumab a cutoff of 28 pg/ml discriminates severe patients from nonsevere (manuscript just accepted in Immunity and Aging). In the present study, the IL-6 concentration of the three patients was above this cutoff. It confirms the classification of these patients as severe and that the CRS is probably occurring.\nSeveral anticytokine therapies have been tried for treating the hyperinflammatory phase of COVID-19 [20,23–25]. Here, we report the use of a well-known anti-inflammatory antibody targeting CD6 to treat the CRS arising in COVID-19 patients. Using an anti-CD6 antibody could reduce the concentration of several pro-inflammatory cytokines, including IL-6, IFN-γ, TNF-α and IL-17, among others, representing an advantage as compared with single-cytokine targeting antibodies. The antibody would not exacerbate lymphopenia since it does not induce complement or antibody dependent cytotoxicity [10,11].\nThese three SARS-CoV2 patients developed severe respiratory distress together with multifocal interstitial pneumonia. Two patients required invasive mechanical ventilation while the third patient only needed oxygen supply. They all received the anti-CD6 antibody itolizumab in combination with other drugs incorporated into the Cuban national protocol, including lopinavir/ritonavir, chloroquine and IFNα-2b. Regarding to laboratory parameters, AST is strongly associated with mortality risk compared with other parameters, reflecting liver and kidney injury [26,27]. In our cases, critically ill patients showed a significant reduction of AST concentration after the treatment suggesting an improvement in the function of these organs.\nItolizumab was very safe and did not seem to exacerbate opportunistic secondary infections. Unfortunately, we did no measure neither the frequency nor the total amount of circulating T cells in these initial patients. The impact of itolizumab on circulating T cells are being implementing in new recruited patients.\nOur preliminary findings support that IL-6 levels correlated with the severity of the disease and that the antibody was capable of reducing IL-6 concentration in all three subjects. One patient died after subsequent respiratory and cardiovascular complications. In this particular case, IL-6 concentration was extremely elevated at the moment of itolizumab infusion. Although, the levels of IL-6 decreased during treatment, the values at 7 days kept still very high (above 300 pg/ml). There was a transient improvement of respiratory function but it was not enough. Presumably, the consequences of the hyperinflammatory syndrome (thrombosis, alveolar damage and severe tissue hypoxia) were irreversible at the moment of treatment and patient died as consequence of these 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