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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 LU orcid ; Neumann, Anca and Elshani, Arsim , et al. (2023) In BMJ Open 13(2).
Abstract

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... (More)

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.

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publishing date
type
Contribution to journal
publication status
published
subject
keywords
Male, Humans, Adult, Middle Aged, Female, COVID-19, SARS-CoV-2, Pregnenediones, Oxygen, Treatment Outcome
in
BMJ Open
volume
13
issue
2
article number
e064374
publisher
BMJ Publishing Group
external identifiers
  • pmid:36813503
  • scopus:85148548652
ISSN
2044-6055
DOI
10.1136/bmjopen-2022-064374
language
English
LU publication?
no
additional info
© 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.
id
69dc4b84-f0ce-44dc-af38-a05957303f0e
date added to LUP
2023-02-26 07:19:05
date last changed
2024-04-19 20:19:23
@article{69dc4b84-f0ce-44dc-af38-a05957303f0e,
  abstract     = {{<p>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.</p><p>DESIGN: Multicentre, randomised, controlled, open-label trial.</p><p>SETTING: 9 hospitals (3 academic hospitals and 6 non-academic hospitals) in Sweden between 1 June 2020 and 17 May 2021.</p><p>PARTICIPANTS: Adults hospitalised with COVID-19 and receiving oxygen therapy.</p><p>INTERVENTION: Inhaled ciclesonide 320 µg two times a day for 14 days versus standard care.</p><p>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.</p><p>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 &lt;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.</p><p>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.</p><p>TRIAL REGISTRATION NUMBER: NCT04381364.</p>}},
  author       = {{Brodin, Daniel and Tornhammar, Per and Ueda, Peter and Krifors, Anders and Westerlund, Eli and Athlin, Simon and Wojt, Sandra and Elvstam, Olof and Neumann, Anca and Elshani, Arsim and Giesecke, Julia and Edvardsson-Källkvist, Jens and Bunpuckdee, Sayam and Unge, Christian and Larsson, Martin and Johansson, Björn and Ljungberg, Johan and Lindell, Jonas and Hansson, Johan and Blennow, Ola and Andersson, Daniel Peter}},
  issn         = {{2044-6055}},
  keywords     = {{Male; Humans; Adult; Middle Aged; Female; COVID-19; SARS-CoV-2; Pregnenediones; Oxygen; Treatment Outcome}},
  language     = {{eng}},
  month        = {{02}},
  number       = {{2}},
  publisher    = {{BMJ Publishing Group}},
  series       = {{BMJ Open}},
  title        = {{Inhaled ciclesonide in adults hospitalised with COVID-19 : a randomised controlled open-label trial (HALT COVID-19)}},
  url          = {{http://dx.doi.org/10.1136/bmjopen-2022-064374}},
  doi          = {{10.1136/bmjopen-2022-064374}},
  volume       = {{13}},
  year         = {{2023}},
}