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Inhaled ciclesonide in adults hospitalised with COVID-19: a randomised controlled open-label trial (HALT COVID-19)
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...
Autores principales: | , , , , , , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BMJ Publishing Group
2023
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9950582/ https://www.ncbi.nlm.nih.gov/pubmed/36813503 http://dx.doi.org/10.1136/bmjopen-2022-064374 |
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author | Brodin, Daniel Tornhammar, Per Ueda, Peter Krifors, Anders Westerlund, Eli Athlin, Simon Wojt, Sandra Elvstam, Olof Neumann, Anca Elshani, Arsim Giesecke, Julia Edvardsson-Källkvist, Jens Bunpuckdee, Sayam Unge, Christian Larsson, Martin Johansson, Björn Ljungberg, Johan Lindell, Jonas Hansson, Johan Blennow, Ola Andersson, Daniel Peter |
author_facet | Brodin, Daniel Tornhammar, Per Ueda, Peter Krifors, Anders Westerlund, Eli Athlin, Simon Wojt, Sandra Elvstam, Olof Neumann, Anca Elshani, Arsim Giesecke, Julia Edvardsson-Källkvist, Jens Bunpuckdee, Sayam Unge, Christian Larsson, Martin Johansson, Björn Ljungberg, Johan Lindell, Jonas Hansson, Johan Blennow, Ola Andersson, Daniel Peter |
author_sort | Brodin, Daniel |
collection | PubMed |
description | 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. |
format | Online Article Text |
id | pubmed-9950582 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2023 |
publisher | BMJ Publishing Group |
record_format | MEDLINE/PubMed |
spelling | pubmed-99505822023-02-25 Inhaled ciclesonide in adults hospitalised with COVID-19: a randomised controlled open-label trial (HALT COVID-19) Brodin, Daniel Tornhammar, Per Ueda, Peter Krifors, Anders Westerlund, Eli Athlin, Simon Wojt, Sandra Elvstam, Olof Neumann, Anca Elshani, Arsim Giesecke, Julia Edvardsson-Källkvist, Jens Bunpuckdee, Sayam Unge, Christian Larsson, Martin Johansson, Björn Ljungberg, Johan Lindell, Jonas Hansson, Johan Blennow, Ola Andersson, Daniel Peter BMJ Open Infectious Diseases 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. BMJ Publishing Group 2023-02-22 /pmc/articles/PMC9950582/ /pubmed/36813503 http://dx.doi.org/10.1136/bmjopen-2022-064374 Text en © 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. https://creativecommons.org/licenses/by-nc/4.0/This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/ (https://creativecommons.org/licenses/by-nc/4.0/) . |
spellingShingle | Infectious Diseases Brodin, Daniel Tornhammar, Per Ueda, Peter Krifors, Anders Westerlund, Eli Athlin, Simon Wojt, Sandra Elvstam, Olof Neumann, Anca Elshani, Arsim Giesecke, Julia Edvardsson-Källkvist, Jens Bunpuckdee, Sayam Unge, Christian Larsson, Martin Johansson, Björn Ljungberg, Johan Lindell, Jonas Hansson, Johan Blennow, Ola Andersson, Daniel Peter Inhaled ciclesonide in adults hospitalised with COVID-19: a randomised controlled open-label trial (HALT COVID-19) |
title | Inhaled ciclesonide in adults hospitalised with COVID-19: a randomised controlled open-label trial (HALT COVID-19) |
title_full | Inhaled ciclesonide in adults hospitalised with COVID-19: a randomised controlled open-label trial (HALT COVID-19) |
title_fullStr | Inhaled ciclesonide in adults hospitalised with COVID-19: a randomised controlled open-label trial (HALT COVID-19) |
title_full_unstemmed | Inhaled ciclesonide in adults hospitalised with COVID-19: a randomised controlled open-label trial (HALT COVID-19) |
title_short | Inhaled ciclesonide in adults hospitalised with COVID-19: a randomised controlled open-label trial (HALT COVID-19) |
title_sort | inhaled ciclesonide in adults hospitalised with covid-19: a randomised controlled open-label trial (halt covid-19) |
topic | Infectious Diseases |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9950582/ https://www.ncbi.nlm.nih.gov/pubmed/36813503 http://dx.doi.org/10.1136/bmjopen-2022-064374 |
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