Inhaled ciclesonide in adults hospitalised with COVID-19: a randomised controlled open-label trial (HALT COVID-19)

• Published in: BMJ Open
• Main Authors: Peter Ueda, Johan Hansson, Johan Ljungberg, Anders Krifors, Björn Johansson, Martin Larsson, Per Tornhammar, Daniel Peter Andersson, Daniel Brodin, Eli Westerlund, Simon Athlin, Sandra Wojt, Olof Elvstam, Anca Neumann, Arsim Elshani, Julia Giesecke, Jens Edvardsson-Källkvist, Sayam Bunpuckdee, Christian Unge, Jonas Lindell, Ola Blennow
• Format: Article
• Language: English
• Published: BMJ Publishing Group 2023-02-01
• Online Access: https://bmjopen.bmj.com/content/13/2/e064374.full

Objective To assess the efficacy of inhaled ciclesonide in reducing the duration of oxygen therapy (an indicator of time to clinical improvement) among adults hospitalised with COVID-19.Design Multicentre, randomised, controlled, open-label trial.Setting 9 hospitals (3 academic hospitals and 6 non-academic hospitals) in Sweden between 1 June 2020 and 17 May 2021.Participants Adults hospitalised with COVID-19 and receiving oxygen therapy.Intervention Inhaled ciclesonide 320 µg two times a day for 14 days versus standard care.Main outcome measures Primary outcome was duration of oxygen therapy, an indicator of time to clinical improvement. Key secondary outcome was a composite of invasive mechanical ventilation/death.Results Data from 98 participants were analysed (48 receiving ciclesonide and 50 receiving standard care; median (IQR) age, 59.5 (49–67) years; 67 (68%) men). Median (IQR) duration of oxygen therapy was 5.5 (3–9) days in the ciclesonide group and 4 (2–7) days in the standard care group (HR for termination of oxygen therapy 0.73 (95% CI 0.47 to 1.11), with the upper 95% CI being compatible with a 10% relative reduction in oxygen therapy duration, corresponding to a <1 day absolute reduction in a post-hoc calculation). Three participants in each group died/received invasive mechanical ventilation (HR 0.90 (95% CI 0.15 to 5.32)). The trial was discontinued early due to slow enrolment.Conclusions In patients hospitalised with COVID-19 receiving oxygen therapy, this trial ruled out, with 0.95 confidence, a treatment effect of ciclesonide corresponding to more than a 1 day reduction in duration of oxygen therapy. Ciclesonide is unlikely to improve this outcome meaningfully.Trial registration number NCT04381364.