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Inhaled ciclesonide...
Inhaled ciclesonide in adults hospitalised with COVID-19 : a randomised controlled open-label trial (HALT COVID-19)
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- Brodin, Daniel (author)
- Department of Medicine, Capio S:t Göran's Hospital, Stockholm, Sweden,Capio St Gorans Hosp, Dept Med, Stockholm, Sweden.
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- Tornhammar, Per (author)
- Functional Area of Emergency Medicine, Karolinska Institute, Stockholm, Sweden,Karolinska Inst, Funct Area Emergency Med, Stockholm, Sweden.
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- Ueda, Peter (author)
- Karolinska Institutet
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- Krifors, Anders (author)
- Karolinska Institutet,Uppsala universitet,Centrum för klinisk forskning, Västerås,Karolinska Inst, Dept Physiol & Pharmacol, Stockholm, Sweden.;Uppsala Univ, Ctr Clin Res Vastmanland, Uppsala, Sweden.
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- Westerlund, Eli (author)
- Karolinska Institutet
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- Athlin, Simon, 1971- (author)
- Örebro universitet,Institutionen för medicinska vetenskaper,Örebro Univ, Sch Med Sci, Örebro, Sweden.
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- Wojt, Sandra (author)
- Department of Internal Medicine, Danderyd Hospital, Stockholm, Sweden,Danderyd Hosp, Dept Internal Med, Stockholm, Sweden.
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- Elvstam, Olof (author)
- Department of Infectious Diseases, Central Hospital Växjö, Vaxjö, Sweden,Cent Hosp Växjö, Dept Infect Dis, Växjö, Sweden.
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- Neumann, Anca (author)
- Department of Medicine, Capio S:t Göran's Hospital, Stockholm, Sweden,Capio St Gorans Hosp, Dept Med, Stockholm, Sweden.
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- Elshani, Arsim (author)
- Department of Medicine and Geriatrics, Karlskoga Hospital, Karlskoga, Sweden,Karlskoga Hosp, Dept Med & Geriatr, Karlskoga, Sweden.
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- Giesecke, Julia (author)
- Functional Area of Emergency Medicine, Karolinska Institute, Stockholm, Sweden,Karolinska Inst, Funct Area Emergency Med, Stockholm, Sweden.
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- Edvardsson-Källkvist, Jens (author)
- Karolinska University Hospital, Stockholm, Sweden,Karolinska Univ Hosp, Stockholm, Sweden.
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- Bunpuckdee, Sayam (author)
- Functional Area of Emergency Medicine, Karolinska Institute, Stockholm, Sweden,Karolinska Inst, Funct Area Emergency Med, Stockholm, Sweden.
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- Unge, Christian (author)
- Department of Internal Medicine, Danderyd Hospital, Stockholm, Sweden,Danderyd Hosp, Dept Internal Med, Stockholm, Sweden.
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- Larsson, Martin (author)
- Department of Endocrinology, Karolinska University Hospital, Stockholm, Sweden; Department of Molecular Medicine and Surgery, Karolinska Institutet, Stockholm, Sweden,Karolinska Univ Hosp, Dept Endocrinol, Stockholm, Sweden.;Karolinska Inst, Dept Mol Med & Surg, Stockholm, Sweden.
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- Johansson, Björn (author)
- Department of Infectious Diseases, Halland's Hospital Halmstad, Halmstad, Sweden,Hallands Hosp Halmstad, Dept Infect Dis, Halmstad, Sweden.
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- Ljungberg, Johan (author)
- Department of Infectious Diseases, Halland's Hospital Halmstad, Halmstad, Sweden,Hallands Hosp Halmstad, Dept Infect Dis, Halmstad, Sweden.
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- Lindell, Jonas (author)
- Department of Infectious Diseases, Visby Hospital, Visby, Sweden,Visby Hosp, Dept Infect Dis, Visby, Sweden.
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- Hansson, Johan (author)
- Department of Infectious Diseases, Östersund Hospital, Östersund, Sweden,Östersund Hosp, Dept Infect Dis, Östersund, Sweden.
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- Blennow, Ola (author)
- Department of Medicine, Capio S:t Göran's Hospital, Stockholm, Sweden; Department of Infectious Diseases, Karolinska University Hospital, Stockholm, Sweden,Capio St Gorans Hosp, Dept Med, Stockholm, Sweden.;Karolinska Univ Hosp, Dept Infect Dis, Stockholm, Sweden.
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- Andersson, Daniel Peter (author)
- Karolinska Institutet
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Department of Medicine, Capio S:t Göran's Hospital, Stockholm, Sweden Capio St Gorans Hosp, Dept Med, Stockholm, Sweden (creator_code:org_t)
- 2023-02-22
- 2023
- English.
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In: BMJ Open. - : BMJ Publishing Group Ltd. - 2044-6055. ; 13:2
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Abstract
Subject headings
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- 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.
Subject headings
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Anestesi och intensivvård (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Anesthesiology and Intensive Care (hsv//eng)
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Kardiologi (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Cardiac and Cardiovascular Systems (hsv//eng)
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Allmänmedicin (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- General Practice (hsv//eng)
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Pediatrik (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Pediatrics (hsv//eng)
Keyword
- COVID-19
- clinical trials
- respiratory infections
Publication and Content Type
- ref (subject category)
- art (subject category)
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BMJ Open
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- By the author/editor
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Brodin, Daniel
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Tornhammar, Per
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Ueda, Peter
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Krifors, Anders
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Westerlund, Eli
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Athlin, Simon, 1 ...
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show more...
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Wojt, Sandra
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Elvstam, Olof
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Neumann, Anca
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Elshani, Arsim
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Giesecke, Julia
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Edvardsson-Källk ...
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Bunpuckdee, Saya ...
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Unge, Christian
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Larsson, Martin
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Johansson, Björn
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Ljungberg, Johan
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Lindell, Jonas
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Hansson, Johan
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Blennow, Ola
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Andersson, Danie ...
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- About the subject
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- MEDICAL AND HEALTH SCIENCES
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MEDICAL AND HEAL ...
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and Clinical Medicin ...
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and Anesthesiology a ...
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- MEDICAL AND HEALTH SCIENCES
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MEDICAL AND HEAL ...
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and Clinical Medicin ...
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and Cardiac and Card ...
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- MEDICAL AND HEALTH SCIENCES
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MEDICAL AND HEAL ...
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and Clinical Medicin ...
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and General Practice
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- MEDICAL AND HEALTH SCIENCES
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MEDICAL AND HEAL ...
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and Clinical Medicin ...
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and Pediatrics
- Articles in the publication
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BMJ Open
- By the university
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Örebro University
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Uppsala University
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Karolinska Institutet