Timing of corticosteroids in non-severe non-hospitalized COVID-19 patients: open-label, two-center, randomized controlled study (TICS-COV19 study)
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Background/Aims: Corticosteroids (CSs) are frequently used in coronavirus disease 2019 (COVID-19); however, their utility remains controversial in mild to moderate cases. The timing of CSs initiation during the disease course remains unaddressed. The study aims to evaluate the impact of early CSs in non-severe COVID-19. Methods: A randomized controlled, open-label study was conducted on 754 COVID-19 patients randomized into a study group (n = 377) in which patients received CSs with COVID-19 protocol and a control group (n = 377) in which patients received COVID-19 protocol only. Results: Both groups were comparable regarding baseline characteristics, presenting symptoms, and inflammatory markers. The composite endpoint (need for O2, need for hospitalization or 28-day mortality) was significantly (p = 0.004) lower in the CS group 42 (11.14%) versus the control group 70 (18.67%) with odds ratio 0.55 (95% confidence interval [CI], 0.36 to 0.83), absolute risk reduction 7.53% (95% CI, 2.46% to 12.59%) and number needed to treat of 13.29 (95% CI, 7.94 to 40.61). Regarding severity at day 10, only (11.1%) of the study group patients were severe versus (18.7%) of the control group patients (p < 0.001). The median time-to-return to daily activity in the CS group was 8.0 days, while in the control group, it was 22.0 days (p < 0.001). Conclusions: In non-severe COVID-19, CS may decrease hospitalization, severity, and mortality.
Abstract
Background/Aims: Corticosteroids (CSs) are frequently used in coronavirus disease 2019 (COVID-19); however, their utility remains controversial in mild to moderate cases. The timing of CSs initiation during the disease course remains unaddressed. The study aims to evaluate the impact of early CSs in non-severe COVID-19. Methods: A randomized controlled, open-label study was conducted on 754 COVID-19 patients randomized into a study group (n = 377) in which patients received CSs with COVID-19 protocol and a control group (n = 377) in which patients received COVID-19 protocol only. Results: Both groups were comparable regarding baseline characteristics, presenting symptoms, and inflammatory markers. The composite endpoint (need for O2, need for hospitalization or 28-day mortality) was significantly (p = 0.004) lower in the CS group 42 (11.14%) versus the control group 70 (18.67%) with odds ratio 0.55 (95% confidence interval [CI], 0.36 to 0.83), absolute risk reduction 7.53% (95% CI, 2.46% to 12.59%) and number needed to treat of 13.29 (95% CI, 7.94 to 40.61). Regarding severity at day 10, only (11.1%) of the study group patients were severe versus (18.7%) of the control group patients (p < 0.001). The median time-to-return to daily activity in the CS group was 8.0 days, while in the control group, it was 22.0 days (p < 0.001). Conclusions: In non-severe COVID-19, CS may decrease hospitalization, severity, and mortality.
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