(30 July 2020) Itolizumab- associated with a reduction in the COVID-19 disease worsening and mortality

Use of a humanized anti-CD6 monoclonal antibody (itolizumab) in elderly
patients with moderate COVID-19

https://doi.org/10.1101/2020.07.24.20153833

To preliminary assess the effect of itolizumab (CT-RPCEC00000311), a control group was selected among the Cuban COVID-19 patients, which did not receive immunomodulatory therapy. Control subjects were well-matched regarding age, comorbidities and severity of the disease. After the first dose, the course of the disease was favorable and 18 out of 19 (94.7%) patients were discharged clinically recovered with negative RT-PCR at 13 days (median). One dose of itolizumab, circulating IL-6 decreased in the first 24-48 hours in patients with high baseline valuesEvery three moderately ill patients treated with itolizumab, one admission in intensive care unit (ICU) was prevented.  Itolizumab was well tolerated. Its effect is associated with a reduction and controlling IL-6 serum levels. Moreover, treated patients had a favorable clinical outcome, considering their poor prognosis. This treatment is associated significantly with a decrease the risk to be admitted in ICU and reduced 10 times the risk of death. This study corroborates that the timely use of itolizumab, in combination with other antiviral and anticoagulant therapies, is associated with a reduction the COVID-19 disease worsening and mortality. The humanized antibody itolizumab emerges as a therapeutic alternative for patients with COVID-19 and suggests its possible use in patients with cytokine release syndrome from other pathologies.