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

Autor:	Brodin D; Department of Medicine, Capio S:t Göran's Hospital, Stockholm, Sweden., Tornhammar P; Functional Area of Emergency Medicine, Karolinska Institute, Stockholm, Sweden., Ueda P; Clinical Epidemiology Division, Department of Medicine, Solna, Karolinska Institutet, Stockholm, Sweden., Krifors A; Department of Physiology and Pharmacology, Karolinska Institutet, Stockholm, Sweden.; Centre for Clinical Research Västmanland, Uppsala University, Uppsala, Sweden., Westerlund E; Department of Clinical Sciences, Danderyd Hospital, Stockholm, Sweden., Athlin S; School of Medical Science, Örebro University, Örebro, Sweden., Wojt S; Department of Internal Medicine, Danderyd Hospital, Stockholm, Sweden., Elvstam O; Department of Infectious Diseases, Central Hospital Växjö, Vaxjo, Sweden., Neumann A; Department of Medicine, Capio S:t Göran's Hospital, Stockholm, Sweden., Elshani A; Department of Medicine and Geriatrics, Karlskoga Hospital, Karlskoga, Sweden., Giesecke J; Functional Area of Emergency Medicine, Karolinska Institute, Stockholm, Sweden., Edvardsson-Källkvist J; Karolinska University Hospital, Stockholm, Sweden., Bunpuckdee S; Functional Area of Emergency Medicine, Karolinska Institute, Stockholm, Sweden., Unge C; Department of Internal Medicine, Danderyd Hospital, Stockholm, Sweden., Larsson M; Department of Endocrinology, Karolinska University Hospital, Stockholm, Sweden.; Department of Molecular Medicine and Surgery, Karolinska Institutet, Stockholm, Sweden., Johansson B; Department of Infectious Diseases, Halland's Hospital Halmstad, Halmstad, Sweden., Ljungberg J; Department of Infectious Diseases, Halland's Hospital Halmstad, Halmstad, Sweden., Lindell J; Department of Infectious Diseases, Visby Hospital, Visby, Sweden., Hansson J; Department of Infectious Diseases, Östersund Hospital, Ostersund, Sweden., Blennow O; Department of Medicine, Capio S:t Göran's Hospital, Stockholm, Sweden ola.blennow@regionstockholm.se.; Department of Infectious Diseases, Karolinska University Hospital, Stockholm, Sweden., Andersson DP; Department of Medicine Huddinge H7, Karolinska Institutet, Karolinska University Hospital, Stockholm, Sweden.
Jazyk:	angličtina
Zdroj:	BMJ open [BMJ Open] 2023 Feb 22; Vol. 13 (2), pp. e064374. Date of Electronic Publication: 2023 Feb 22.
DOI:	10.1136/bmjopen-2022-064374
Abstrakt:	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. Competing Interests: Competing interests: This study received non-financial support from COVIS Pharma (study drug donation). The authors have no conflict of interest to disclose. (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)
Databáze:	MEDLINE
Externí odkaz:	Zobrazit plný text záznamu