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Randomised, control...
Randomised, controlled, open label, multicentre clinical trial to explore safety and efficacy of hyperbaric oxygen for preventing ICU admission, morbidity and mortality in adult patients with COVID-19
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- Kjellberg, A. (author)
- Karolinska Institutet,Karolinska, SWE
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- Douglas, J. (author)
- Blekingesjukhuset, SWE
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- Pawlik, M. T. (author)
- Catholic Charities Hosp, DEU
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- Kraus, M. (author)
- Bergmannsheil & Kinderklin Buer GmbH, DEU
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- Oscarsson, Nicklas, 1974 (author)
- Gothenburg University,Göteborgs universitet,Institutionen för kliniska vetenskaper, Avdelningen för anestesiologi och intensivvård,Institute of Clinical Sciences, Department of Anesthesiology and Intensive care,Göteborgs University, SWE
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- Zheng, X. W. (author)
- Karolinska Institutet,Karolinska, SWE
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- Bergman, P. (author)
- Karolinska Institutet,Karolinska, SWE
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- Frånberg, Oskar, 1976- (author)
- Blekinge Tekniska Högskola,Institutionen för maskinteknik,Institutionen för matematik och naturvetenskap
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- Kowalski, J. H. (author)
- JK Biostat AB, SWE
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- Nyren, S. P. (author)
- Karolinska, SWE
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- Silvanius, Mårten (author)
- Blekinge Tekniska Högskola,Institutionen för matematik och naturvetenskap,SwAF Diving and Naval Medicine Centre, Swedish Armed Forces, Karlskrona,
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- Skold, M. (author)
- Karolinska Institutet,Karolinska, SWE
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- Catrina, S. B. (author)
- Karolinska Institutet,Karolinska, SWE
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- Rodriguez-Wallberg, K. A. (author)
- Karolinska, SWE
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- Lindholm, P. (author)
- Karolinska Institutet,Karolinska, SWE
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(creator_code:org_t)
- 2021-07-05
- 2021
- English.
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In: BMJ Open. - : BMJ. - 2044-6055. ; 11:7
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https://doi.org/10.1...
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https://bth.diva-por... (primary) (Raw object)
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https://gup.ub.gu.se...
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Abstract
Subject headings
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- Introduction COVID-19 may cause severe pneumonitis and trigger a massive inflammatory response that requires ventilatory support. The intensive care unit (ICU)-mortality has been reported to be as high as 62%. Dexamethasone is the only of all anti-inflammatory drugs that have been tested to date that has shown a positive effect on mortality. We aim to explore if treatment with hyperbaric oxygen (HBO) is safe and effective for patients with severe COVID-19. Our hypothesis is that HBO can prevent ICU admission, morbidity and mortality by attenuating the inflammatory response. The primary objective is to evaluate if HBO reduces the number of ICU admissions compared with best practice treatment for COVID-19, main secondary objectives are to evaluate if HBO reduces the load on ICU resources, morbidity and mortality and to evaluate if HBO mitigates the inflammatory reaction in COVID-19. Methods and analysis A randomised, controlled, phase II, open label, multicentre trial. 200 subjects with severe COVID-19 and at least two risk factors for mortality will be included. Baseline clinical data and blood samples will be collected before randomisation and repeated daily for 7 days, at days 14 and 30. Subjects will be randomised with a computer-based system to HBO, maximum five times during the first 7 days plus best practice treatment or only best practice treatment. The primary endpoint, ICU admission, is defined by criteria for selection for ICU. We will evaluate if HBO mitigates the inflammatory reaction in COVID-19 using molecular analyses. All parameters are recorded in an electronic case report form. An independent Data Safety Monitoring Board will review the safety parameters. Ethics and dissemination The trial is approved by The National Institutional Review Board in Sweden (2020-01705) and the Swedish Medical Product Agency (5.1-2020-36673). Positive, negative and any inconclusive results will be published in peer-reviewed scientific journals with open access.
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 -- Infektionsmedicin (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Infectious Medicine (hsv//eng)
Keyword
- COVID-19
- intensive & critical care
- immunology
- infectious diseases
- thoracic medicine
- therapy
- decompression
- mechanisms
- blood
- General & Internal Medicine
- COVID-19
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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Kjellberg, A.
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Douglas, J.
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Pawlik, M. T.
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Kraus, M.
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Oscarsson, Nickl ...
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Zheng, X. W.
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show more...
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Bergman, P.
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Frånberg, Oskar, ...
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Kowalski, J. H.
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Nyren, S. P.
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Silvanius, Mårte ...
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Skold, M.
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Catrina, S. B.
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Rodriguez-Wallbe ...
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Lindholm, P.
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show less...
- 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 Infectious Medic ...
- Articles in the publication
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BMJ Open
- By the university
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University of Gothenburg
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Karolinska Institutet
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Blekinge Institute of Technology