Forty-eight patients with moderate COVID-19-related pneumonia were asked to participate in the prospective case-control study: 33 patients (cases) signed informed consent and received canakinumab (Cohort 1) and 15 patients (Controls) refused to receive the experimental drug and received institutional standard of care (Cohort 2). Results Hospital discharge within 21 days was seen in 63% of patients in Cohort 1 vs. in patients treated with canakinumab and 73.3% (95% CI 43.6C89.1) for Cohort 2. Conclusions Treatment with canakinumab in patients with COVID-19-related pneumonia rapidly restored normal oxygen status, decreased the need for invasive mechanical ventilation, and was associated with earlier hospital discharge and favourable prognosis versus standard of care. 0.05. Results Patient characteristics From 01 to 25 April 2020, 48 patients with moderate COVID-19 Pyridoclax (MR-29072) and pneumonia were included: 33 were treated with canakinumab (Cohort 1) and 15 (Cohort 2) received the institutional standard of care. All Pyridoclax (MR-29072) patients were managed outside of the ICU. Baseline characteristics are summarised in Table 1 . Median age was comparable in Cohort 1 (70 years, range 29C89) and Cohort 2 (69 years, range 44C85). The majority of patients were male (76% for Cohort 1 and 87% in Cohort 2). The range of comorbidities and presenting symptoms were broadly comparable in both groups. Patients in both groups had received treatment with antivirals, hydroxychloroquine and antibiotics (see Supplementary Appendix) before entering the study. For treating COVID-19-related pneumonia, patients in Cohort 1 received canakinumab and heparin and those in Cohort 2 received high-dose (10,000 IU) heparin only. Table 1 Demographic characteristics of patients enrolled in the prospective interventional study. 0.001). In Cohort 2, which received high-dose heparin only, there were no significant changes Rabbit Polyclonal to OR1N1 in clinical benefit and/or reduction in ventilation needed at pre-treatment and post-treatment times (= 0.28). While 13.3% of patients still needed NIV, 26.7% were maintained on CPAP, and supplemental oxygen was needed for 53.3% of patients. At the end of the same period of observation, 6.7% of patients were no longer in need of supplemental oxygen. This study also compared the PaO2:FiO2 ratio and chest CT before starting canakinumab and at 7C10 days after the second injection of the anti-IL1 antibody. The same comparison was performed in Cohort 2 during the same time frame of patients receiving canakinumab. The ventilation approaches in the two cohorts were comparable at baseline; however, more patients needed less invasive types of ventilation after administration of canakinumab. As shown in Table 2 , compared with baseline, patients treated with canakinumab experienced a significant increase in the PaO2:FiO2 ratio ( 0.001) and a reduction in lung damage evaluated by CT (= 0.01). Cohort 2 had clinical benefit only in the PaO2:FiO2 ratio (= 0.05). No significant correlation was observed between the change () in PaO2:FiO2 ratio, or in lung damage in controls (Table S1). Physique 1 shows the changes in lung damage related to COVID-19 induced by Pyridoclax (MR-29072) canakinumab. Table 2 Changes in PaO2/FiO2 ratio and lung damage evaluated by chest CT (%) in Cohort 1 (a) and Cohort 2 Pyridoclax (MR-29072) (b) during the same time period before treatment with canakinumab and at 7C10 days after the second administration of canakinumab. (c) Comparison between the changes measured between before the first administration Pyridoclax (MR-29072) of canakinumab and at follow-up between the two cohorts with regards to the PaO2/FiO2 ratio and lung damage on chest CT scan (%). 0.001), platelets (= 0.005) and neutrophils ( 0.001), and an increase in lymphocytes (= 0.01), over the time of measurement, while no significant variations were found for the same parameters in Cohort 2 (Physique 2 a). The changes over time in immune and inflammatory markers are reported in Tables S3a and S3b, and in Tables S4a and S4b, respectively. Moreover, the neutrophil/lymphocyte ratio, considered as a surrogate.