Inhaled Ciclesonide for Community-Based COVID-19: A Placebo-Controlled Randomised Trial

Inhaled corticosteroids have been proposed as treatment for acute COVID-19 infection in the community. We sought to determine the efficacy and safety of inhaled ciclesonide 320 mcg daily for 14 days compared to placebo in reducing the time to first recovery from all symptoms within 28 days of randomisation.

We conducted a two-arm, double blind, placebo-controlled, community-based randomised trial. Participants received inhaled ciclesonide 320 mcg daily or matching placebo for 14 days. The primary outcome was time to recovery of symptoms to day 28. An updated systematic review of all controlled trials of inhaled corticosteroids for acute COVID-19 was then undertaken.

There were 189 people randomised and 185 completed treatment; 96% were COVID-19 vaccinated. No difference was seen in the time to first recovery using a proportional hazards analysis, recovery rate ratio 1.04 (95% CI; 0.77, 1.40). The median time to recovery with ciclesonide was 7 days (95% CI 6-9), compared with placebo of 7 days (95% CI 6-9), p = 0.84. There were no significant differences in secondary outcomes, including time to sustained recovery and respiratory symptoms. The treatment was safe and well tolerated.

In a highly vaccinated (> 90%) population exposed to Omicron variants of SARS-CoV-2, the addition of inhaled ciclesonide had no effect on accelerating recovery from acute symptoms. These trial results and updated combined evidence of placebo-controlled trials do not support the use of inhaled corticosteroids for the treatment of COVID-19.

ACTRN12620000566932.