Effect of inhaled ciclesonide in non-critically ill hospitalized patients with COVID-19: a multicenter observational study in Japan
Background
Coronavirus disease 2019 (COVID-19) is an ongoing global pandemic. Although systemic steroids play an important role in treating patients with severe COVID-19, the role of inhaled corticosteroids in non-critically ill, hospitalized patients with COVID-19 remains unclear.
Methods
We analyzed non-critically ill, hospitalized patients with COVID-19 who were older than 18 years and were admitted to 64 Japanese hospitals between January and September 2020. We performed propensity score matching analysis to evaluate 28-day mortality and in-hospital mortality with or without inhaled ciclesonide within two days of admission. Sensitivity analyses using inverse probability weighting analysis and the generalized estimating equation method were also performed.
Results
Eligible patients (n = 3,638) were divided into ciclesonide (n = 290) and control (n = 3, 393) groups. One-to-four propensity score matching analysis included 271 ciclesonide users and 1,084 non-users. There were no significant differences between the two groups for 28-day mortality (3.3% vs. 2.3%, risk difference: 1.0%, 95% CI: -1.2 to 3.3), in-hospital mortality (4.8% vs. 2.6%, risk difference: 2.2, 95% CI: -0.5 to 4.9). The sensitivity analysis showed similar outcomes.
Conclusions
From this multicenter observational study in Japan, inhaled ciclesonide did not decrease 28-day mortality and in-hospital mortality in non-critically ill, hospitalized patients with COVID-19. Future large, multinational, randomized trials are required to confirm our results.