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COVID-19-Induced Acute Respiratory Distress Syndrome Treated with Hyperbaric Oxygen: Interim Safety Report from a Randomized Clinical Trial (COVID-19-HBO).

ABSTRACT:

Background

A few prospective trials and case series have suggested that hyperbaric oxygen therapy (HBOT) may be efficacious for the treatment of severe COVID-19, but safety is a concern for critically ill patients. We present an interim analysis of the safety of HBOT via a randomized controlled trial (COVID-19-HBO).

Methods

A randomized controlled, open-label, clinical trial was conducted in compliance with good clinical practice to explore the safety and efficacy of HBOT for severe COVID-19 in critically ill patients with moderate acute respiratory distress syndrome (ARDS). Between 3 June 2020, and 17 May 2021, 31 patients with severe COVID-19 and moderate-to-severe ARDS, a ratio of arterial oxygen partial pressure to fractional inspired oxygen (PaO2/FiO2) < 26.7 kPa (200 mmHg), and at least two defined risk factors for intensive care unit (ICU) admission and/or mortality were enrolled in the trial and randomized 1:1 to best practice, or HBOT in addition to best practice. The subjects allocated to HBOT received a maximum of five treatments at 2.4 atmospheres absolute (ATA) for 80 min over seven days. The subjects were followed up for 30 days. The safety endpoints were analyzed.

Results

Adverse events (AEs) were common. Hypoxia was the most common adverse event reported. There was no statistically significant difference between the groups. Numerically, serious adverse events (SAEs) and barotrauma were more frequent in the control group, and the differences between groups were in favor of the HBOT in PaO2/FiO2 (PFI) and the national early warning score (NEWS); statistically, however, the differences were not significant at day 7, and no difference was observed for the total oxygen burden and cumulative pulmonary oxygen toxicity dose (CPTD).

Conclusion

HBOT appears to be safe as an intervention for critically ill patients with moderate-to-severe ARDS induced by COVID-19.

Clinical trial registration

NCT04327505 (31 March 2020) and EudraCT 2020-001349-37 (24 April 2020).

SUBMITTER: Kjellberg A 

PROVIDER: S-EPMC10381696 | biostudies-literature | 2023 Jul

REPOSITORIES: biostudies-literature

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COVID-19-Induced Acute Respiratory Distress Syndrome Treated with Hyperbaric Oxygen: Interim Safety Report from a Randomized Clinical Trial (COVID-19-HBO).

Kjellberg Anders A   Douglas Johan J   Hassler Adrian A   Al-Ezerjawi Sarah S   Boström Emil E   Abdel-Halim Lina L   Liwenborg Lovisa L   Hetting Eric E   Jonasdottir Njåstad Anna Dora AD   Kowalski Jan J   Catrina Sergiu-Bogdan SB   Rodriguez-Wallberg Kenny A KA   Lindholm Peter P  

Journal of clinical medicine 20230724 14

<h4>Background</h4>A few prospective trials and case series have suggested that hyperbaric oxygen therapy (HBOT) may be efficacious for the treatment of severe COVID-19, but safety is a concern for critically ill patients. We present an interim analysis of the safety of HBOT via a randomized controlled trial (COVID-19-HBO).<h4>Methods</h4>A randomized controlled, open-label, clinical trial was conducted in compliance with good clinical practice to explore the safety and efficacy of HBOT for seve  ...[more]