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

Brodin, Daniel (författare)
Department of Medicine, Capio S:t Göran's Hospital, Stockholm, Sweden,Capio St Gorans Hosp, Dept Med, Stockholm, Sweden.
Tornhammar, Per (författare)
Functional Area of Emergency Medicine, Karolinska Institute, Stockholm, Sweden,Karolinska Inst, Funct Area Emergency Med, Stockholm, Sweden.
Ueda, Peter (författare)
Karolinska Institutet
visa fler...
Krifors, Anders (författare)
Uppsala universitet,Centrum för klinisk forskning, Västerås,Karolinska Inst, Dept Physiol & Pharmacol, Stockholm, Sweden.;Uppsala Univ, Ctr Clin Res Vastmanland, Uppsala, Sweden.
Westerlund, Eli (författare)
Karolinska Institutet
Athlin, Simon, 1971- (författare)
Örebro universitet,Institutionen för medicinska vetenskaper,Örebro Univ, Sch Med Sci, Örebro, Sweden.
Wojt, Sandra (författare)
Department of Internal Medicine, Danderyd Hospital, Stockholm, Sweden,Danderyd Hosp, Dept Internal Med, Stockholm, Sweden.
Elvstam, Olof (författare)
Department of Infectious Diseases, Central Hospital Växjö, Vaxjö, Sweden,Cent Hosp Växjö, Dept Infect Dis, Växjö, Sweden.
Neumann, Anca (författare)
Department of Medicine, Capio S:t Göran's Hospital, Stockholm, Sweden,Capio St Gorans Hosp, Dept Med, Stockholm, Sweden.
Elshani, Arsim (författare)
Department of Medicine and Geriatrics, Karlskoga Hospital, Karlskoga, Sweden,Karlskoga Hosp, Dept Med & Geriatr, Karlskoga, Sweden.
Giesecke, Julia (författare)
Functional Area of Emergency Medicine, Karolinska Institute, Stockholm, Sweden,Karolinska Inst, Funct Area Emergency Med, Stockholm, Sweden.
Edvardsson-Källkvist, Jens (författare)
Karolinska University Hospital, Stockholm, Sweden,Karolinska Univ Hosp, Stockholm, Sweden.
Bunpuckdee, Sayam (författare)
Functional Area of Emergency Medicine, Karolinska Institute, Stockholm, Sweden,Karolinska Inst, Funct Area Emergency Med, Stockholm, Sweden.
Unge, Christian (författare)
Department of Internal Medicine, Danderyd Hospital, Stockholm, Sweden,Danderyd Hosp, Dept Internal Med, Stockholm, Sweden.
Larsson, Martin (författare)
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.
Johansson, Björn (författare)
Department of Infectious Diseases, Halland's Hospital Halmstad, Halmstad, Sweden,Hallands Hosp Halmstad, Dept Infect Dis, Halmstad, Sweden.
Ljungberg, Johan (författare)
Department of Infectious Diseases, Halland's Hospital Halmstad, Halmstad, Sweden,Hallands Hosp Halmstad, Dept Infect Dis, Halmstad, Sweden.
Lindell, Jonas (författare)
Department of Infectious Diseases, Visby Hospital, Visby, Sweden,Visby Hosp, Dept Infect Dis, Visby, Sweden.
Hansson, Johan (författare)
Department of Infectious Diseases, Östersund Hospital, Östersund, Sweden,Östersund Hosp, Dept Infect Dis, Östersund, Sweden.
Blennow, Ola (författare)
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.
Andersson, Daniel Peter (författare)
Karolinska Institutet
visa färre...
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
Engelska.
Ingår i: BMJ Open. - : BMJ Publishing Group Ltd. - 2044-6055. ; 13:2
  • Tidskriftsartikel (refereegranskat)
Abstract Ämnesord
Stäng  
  • 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.

Ämnesord

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)

Nyckelord

COVID-19
clinical trials
respiratory infections

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