Outcomes and analysis
toxicity
ADVERSE EVENTS, EVENT, SECONDARY
Regarding the primary objective of the study in the intention to treat population, 11 (22%) patients in the control arm and 6 (12%) in the experimental arm reached an OSCI grade of 5 or higher (p = 0.29).In the “per protocol” population numbers were smaller (p = 0.0002) with 4 (9%) and 7 (16%) in the control and experimental arms respectively (p = 0.52). Worsening of SpFiO2 was observed in 11 (24%) patients in the control arm and 11 (24%) in the experimental arm (p > 0.99). Median time (days) to SpFiO2 worsening (1 [IQR 1-2.5] vs 2 [IQR 1-3]; p=0.43), time to clinical worsening (2.5 [IQR 2-10.8] vs 3.0 [IQR 2.5-10.5]; p = 0.77) and time from randomization to discharge (7.0 [IQR 5.0 - 10] vs 8.0 [IQR 5.0 - 11.8]; p=0.5) was similar in the control and experimental arms (Clinical outcomes. Cumulative distribution for different clinical outcomes (time to event in days): SpFiO2 worsening [< 300] Three patients required admission to the ICU (one in the control and 2 in the experimental arm) and four died (2 in the control and 2 in the experimental arm).Additional analysis included the number and percentage of patients with SpFiO2 recovery and clinical recovery, time to clinical improvement, time to SpFiO2 recovery and time to lymphocyte recovery, with no significant difference between groups (Overall population outcome by study arm.OSCI: WHO-Ordinal Scale for Clinical Improvement *t-Student; ** Chi-squared test, *** Fisher test; **** Mann-Whitney U test.Up to 13 cases (28%) crossed over to the ruxolitinib treatment arm.Median time on ruxolitinib treatment was 11 (9 - 12) days for patients allocated to the experimental arm and 11 (8 – 13.8) days for those who were initially assigned to SOC and crossed over to receive ruxolitinib.All patients who received ruxolitinib reached a dose of 10mg BID or greater.In the overall ‘per protocol’ population, 30% were on statins before study entry (equally distributed in both arms).Also, there were no significant differences regarding the administration of corticosteroids (77%), anticoagulants (97%), tocilizumab (29%) or any other drug (Regarding toxicity, there were no severe adverse events attributed to the experimental treatment and dose interruptions were not required. All secondary effects were equally distributed between the study arms (