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Hyperbaric oxygen for treatment of long COVID-19 syndrome (HOT-LoCO): protocol for a randomised, placebo-controlled, double-blind, phase II clinical trial

INTRODUCTION: Long COVID-19, where symptoms persist 12 weeks after the initial SARS-CoV-2-infection, is a substantial problem for individuals and society in the surge of the pandemic. Common symptoms are fatigue, postexertional malaise and cognitive dysfunction. There is currently no effective treat...

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Autores principales: Kjellberg, Anders, Abdel-Halim, Lina, Hassler, Adrian, El Gharbi, Sara, Al-Ezerjawi, Sarah, Boström, Emil, Sundberg, Carl Johan, Pernow, John, Medson, Koshiar, Kowalski, Jan H, Rodriguez-Wallberg, Kenny A, Zheng, Xiaowei, Catrina, Sergiu, Runold, Michael, Ståhlberg, Marcus, Bruchfeld, Judith, Nygren-Bonnier, Malin, Lindholm, Peter
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BMJ Publishing Group 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9638753/
https://www.ncbi.nlm.nih.gov/pubmed/36323462
http://dx.doi.org/10.1136/bmjopen-2022-061870
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author Kjellberg, Anders
Abdel-Halim, Lina
Hassler, Adrian
El Gharbi, Sara
Al-Ezerjawi, Sarah
Boström, Emil
Sundberg, Carl Johan
Pernow, John
Medson, Koshiar
Kowalski, Jan H
Rodriguez-Wallberg, Kenny A
Zheng, Xiaowei
Catrina, Sergiu
Runold, Michael
Ståhlberg, Marcus
Bruchfeld, Judith
Nygren-Bonnier, Malin
Lindholm, Peter
author_facet Kjellberg, Anders
Abdel-Halim, Lina
Hassler, Adrian
El Gharbi, Sara
Al-Ezerjawi, Sarah
Boström, Emil
Sundberg, Carl Johan
Pernow, John
Medson, Koshiar
Kowalski, Jan H
Rodriguez-Wallberg, Kenny A
Zheng, Xiaowei
Catrina, Sergiu
Runold, Michael
Ståhlberg, Marcus
Bruchfeld, Judith
Nygren-Bonnier, Malin
Lindholm, Peter
author_sort Kjellberg, Anders
collection PubMed
description INTRODUCTION: Long COVID-19, where symptoms persist 12 weeks after the initial SARS-CoV-2-infection, is a substantial problem for individuals and society in the surge of the pandemic. Common symptoms are fatigue, postexertional malaise and cognitive dysfunction. There is currently no effective treatment and the underlying mechanisms are unknown, although several hypotheses exist, with chronic inflammation as a common denominator. In prospective studies, hyperbaric oxygen therapy (HBOT) has been suggested to be effective for the treatment of similar syndromes such as chronic fatigue syndrome and fibromyalgia. A case series has suggested positive effects of HBOT in long COVID-19. This randomised, placebo-controlled clinical trial will explore HBOT as a potential treatment for long COVID-19. The primary objective is to evaluate if HBOT improves health-related quality of life (HRQoL) for patients with long COVID-19 compared with placebo/sham. The main secondary objective is to evaluate whether HBOT improves endothelial function, objective physical performance and short-term HRQoL. METHODS AND ANALYSIS: A randomised, placebo-controlled, double-blind, phase II clinical trial in 80 previously healthy subjects debilitated due to long COVID-19, with low HRQoL. Clinical data, HRQoL questionnaires, blood samples, objective tests and activity metre data will be collected at baseline. Subjects will be randomised to a maximum of 10 treatments with hyperbaric oxygen or sham treatment over 6 weeks. Assessments for safety and efficacy will be performed at 6, 13, 26 and 52 weeks, with the primary endpoint (physical domains in RAND 36-Item Health Survey) and main secondary endpoints defined at 13 weeks after baseline. Data will be reviewed by an independent data safety monitoring board. ETHICS AND DISSEMINATION: The trial is approved by the Swedish National Institutional Review Board (2021–02634) and the Swedish Medical Products Agency (5.1-2020-36673). Positive, negative and inconclusive results will be published in peer-reviewed scientific journals with open access. TRIAL REGISTRATION NUMBER: NCT04842448.
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spelling pubmed-96387532022-11-07 Hyperbaric oxygen for treatment of long COVID-19 syndrome (HOT-LoCO): protocol for a randomised, placebo-controlled, double-blind, phase II clinical trial Kjellberg, Anders Abdel-Halim, Lina Hassler, Adrian El Gharbi, Sara Al-Ezerjawi, Sarah Boström, Emil Sundberg, Carl Johan Pernow, John Medson, Koshiar Kowalski, Jan H Rodriguez-Wallberg, Kenny A Zheng, Xiaowei Catrina, Sergiu Runold, Michael Ståhlberg, Marcus Bruchfeld, Judith Nygren-Bonnier, Malin Lindholm, Peter BMJ Open Pharmacology and Therapeutics INTRODUCTION: Long COVID-19, where symptoms persist 12 weeks after the initial SARS-CoV-2-infection, is a substantial problem for individuals and society in the surge of the pandemic. Common symptoms are fatigue, postexertional malaise and cognitive dysfunction. There is currently no effective treatment and the underlying mechanisms are unknown, although several hypotheses exist, with chronic inflammation as a common denominator. In prospective studies, hyperbaric oxygen therapy (HBOT) has been suggested to be effective for the treatment of similar syndromes such as chronic fatigue syndrome and fibromyalgia. A case series has suggested positive effects of HBOT in long COVID-19. This randomised, placebo-controlled clinical trial will explore HBOT as a potential treatment for long COVID-19. The primary objective is to evaluate if HBOT improves health-related quality of life (HRQoL) for patients with long COVID-19 compared with placebo/sham. The main secondary objective is to evaluate whether HBOT improves endothelial function, objective physical performance and short-term HRQoL. METHODS AND ANALYSIS: A randomised, placebo-controlled, double-blind, phase II clinical trial in 80 previously healthy subjects debilitated due to long COVID-19, with low HRQoL. Clinical data, HRQoL questionnaires, blood samples, objective tests and activity metre data will be collected at baseline. Subjects will be randomised to a maximum of 10 treatments with hyperbaric oxygen or sham treatment over 6 weeks. Assessments for safety and efficacy will be performed at 6, 13, 26 and 52 weeks, with the primary endpoint (physical domains in RAND 36-Item Health Survey) and main secondary endpoints defined at 13 weeks after baseline. Data will be reviewed by an independent data safety monitoring board. ETHICS AND DISSEMINATION: The trial is approved by the Swedish National Institutional Review Board (2021–02634) and the Swedish Medical Products Agency (5.1-2020-36673). Positive, negative and inconclusive results will be published in peer-reviewed scientific journals with open access. TRIAL REGISTRATION NUMBER: NCT04842448. BMJ Publishing Group 2022-11-02 /pmc/articles/PMC9638753/ /pubmed/36323462 http://dx.doi.org/10.1136/bmjopen-2022-061870 Text en © Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. https://creativecommons.org/licenses/by-nc/4.0/This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/ (https://creativecommons.org/licenses/by-nc/4.0/) .
spellingShingle Pharmacology and Therapeutics
Kjellberg, Anders
Abdel-Halim, Lina
Hassler, Adrian
El Gharbi, Sara
Al-Ezerjawi, Sarah
Boström, Emil
Sundberg, Carl Johan
Pernow, John
Medson, Koshiar
Kowalski, Jan H
Rodriguez-Wallberg, Kenny A
Zheng, Xiaowei
Catrina, Sergiu
Runold, Michael
Ståhlberg, Marcus
Bruchfeld, Judith
Nygren-Bonnier, Malin
Lindholm, Peter
Hyperbaric oxygen for treatment of long COVID-19 syndrome (HOT-LoCO): protocol for a randomised, placebo-controlled, double-blind, phase II clinical trial
title Hyperbaric oxygen for treatment of long COVID-19 syndrome (HOT-LoCO): protocol for a randomised, placebo-controlled, double-blind, phase II clinical trial
title_full Hyperbaric oxygen for treatment of long COVID-19 syndrome (HOT-LoCO): protocol for a randomised, placebo-controlled, double-blind, phase II clinical trial
title_fullStr Hyperbaric oxygen for treatment of long COVID-19 syndrome (HOT-LoCO): protocol for a randomised, placebo-controlled, double-blind, phase II clinical trial
title_full_unstemmed Hyperbaric oxygen for treatment of long COVID-19 syndrome (HOT-LoCO): protocol for a randomised, placebo-controlled, double-blind, phase II clinical trial
title_short Hyperbaric oxygen for treatment of long COVID-19 syndrome (HOT-LoCO): protocol for a randomised, placebo-controlled, double-blind, phase II clinical trial
title_sort hyperbaric oxygen for treatment of long covid-19 syndrome (hot-loco): protocol for a randomised, placebo-controlled, double-blind, phase ii clinical trial
topic Pharmacology and Therapeutics
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9638753/
https://www.ncbi.nlm.nih.gov/pubmed/36323462
http://dx.doi.org/10.1136/bmjopen-2022-061870
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