Introduction:

COVID-19 can lead to a hyper-inflammatory state. CD6 is a glycoprotein expressed on mature T-lymphocytes, which is a crucial regulator of the T-cell activation. Itolizumab is an antibody targeting CD6. Clinical data in autoimmune diseases indicate that it lowers multiple cytokines primarily involving the Th1/Th17 pathway. Objective: to preliminarily assess the safety and impact of itolizumab on interleukin-6, pulmonary function and mortality of COVID-19 patients.

Methods:

Sixty-eight moderate, severe and critical patients were included in an expanded-access trial in Cuba. Itolizumab was administered together with other therapies included in the national protocol for SARS-CoV-2.

Results:

All patients completed the first infusion and 41 received 2 doses. Median age was 68 and 94 % have comorbidities. Itolizumab improved the lung function and was well tolerated; 3 subjects had related serious adverse events. Interleukin-6 decreased in individuals with high levels and did not change in those with lower concentration. 14-day lethality rate was 4 % and 18 % for moderate and severe patients. Although this was not a randomized study, preliminary data suggest that itolizumab reduced the death probability in comparison to controls. Time to treatment, neurological manifestations, biomarkers like NLR, neutrophil count and interleukin-6 were significantly associated with higher lethality. Conclusions. Itolizumab can disrupt the inflammatory cascade and might prevent the COVID-19 associated morbidity and mortality.

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