Inhaled ciclesonide in adults hospitalised with COVID-19 : a randomised controlled open-label trial (HALT COVID-19)
© 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..
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.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2023 |
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| Erschienen: |
2023 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:13 |
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| Enthalten in: |
BMJ open - 13(2023), 2 vom: 22. Feb., Seite e064374 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Brodin, Daniel [VerfasserIn] |
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| Links: |
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| Themen: |
COVID-19 |
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| Anmerkungen: |
Date Completed 24.02.2023 Date Revised 09.03.2023 published: Electronic ClinicalTrials.gov: NCT04381364 Citation Status MEDLINE |
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| doi: |
10.1136/bmjopen-2022-064374 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| 100 | 1 | |a Brodin, Daniel |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Inhaled ciclesonide in adults hospitalised with COVID-19 |b a randomised controlled open-label trial (HALT COVID-19) |
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| 500 | |a Date Revised 09.03.2023 | ||
| 500 | |a published: Electronic | ||
| 500 | |a ClinicalTrials.gov: NCT04381364 | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a © 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. | ||
| 520 | |a 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 | ||
| 520 | |a DESIGN: Multicentre, randomised, controlled, open-label trial | ||
| 520 | |a SETTING: 9 hospitals (3 academic hospitals and 6 non-academic hospitals) in Sweden between 1 June 2020 and 17 May 2021 | ||
| 520 | |a PARTICIPANTS: Adults hospitalised with COVID-19 and receiving oxygen therapy | ||
| 520 | |a INTERVENTION: Inhaled ciclesonide 320 µg two times a day for 14 days versus standard care | ||
| 520 | |a 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 | ||
| 520 | |a 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 | ||
| 520 | |a 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 | ||
| 520 | |a TRIAL REGISTRATION NUMBER: NCT04381364 | ||
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| 700 | 1 | |a Unge, Christian |e verfasserin |4 aut | |
| 700 | 1 | |a Larsson, Martin |e verfasserin |4 aut | |
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| 700 | 1 | |a Andersson, Daniel Peter |e verfasserin |4 aut | |
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