COVID-19 induced acute respiratory distress syndrome treated with Hyperbaric Oxygen: Interim safety report from a multicenter, randomised, open-label phase II clinical trial (COVID-19-HBO)

Abstract Purpose: A few prospective trials and case series have suggested efficacy of hyperbaric oxygen therapy (HBOT) for treatment of severe COVID-19 but safety is a concern, especially for critically ill patients. We present the safety interim analysis of the randomised controlled trial COVID-19-HBO Methods: Randomised controlled, open label, clinical trial 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 June 3 2020 and May 17 2021, 31 patients with Severe COVID-19 and moderate to severe ARDS; PaO2/FiO2 <26.7kPa (200mmHg) and at least 2 defined risk factors for ICU admission and/or mortality were enrolled in the trial and randomised 1:1 to Best practice or HBOT in addition to Best practice. Subjects allocated to HBOT received maximum 5 treatments 240 kPa, 80 minutes, during 7 days. Follow up was 30 days. Safety endpoints were analysed.Results: Adverse events (AE) were common, hypoxia was most commonly reported, there was no statistically significant difference between the groups. Numerically, serious adverse events (SAE) and barotrauma were more frequent in the control group. Numerically differences were in favor of the HBOT in PFI, NEWS but statistically not significant at day 7, and no difference was observed for the total oxygen burden and Cumulative Pulmonary oxygen Toxicity Dose (CPTD).Conclusions: HBOT appears safe as an intervention for critically ill patients with moderate to severe acute respiratory distress syndrome (ARDS) induced by COVID-19.Trial registration: NCT04327505 (March 31, 2020) and EudraCT 2020-001349-37 (April 24, 2020)