Hyperbaric oxygen as an adjuvant treatment for patients with COVID-19 severe hypoxaemia: a randomised controlled trial

Abstract

BackgroundHyperbaric oxygen (HBO2) therapy has been proposed to treat hypoxaemia and reduce inflammation in COVID-19. Our objective was to analyse safety and efficacy of HBO2 in treatment of hypoxaemia in patients with COVID-19 and evaluate time to hypoxaemia correction.MethodsThis was a multicentre, open-label randomised controlled trial conducted in Buenos Aires, Argentina, between July and November 2020. Patients with COVID-19 and severe hypoxaemia (SpO2 ≤90% despite oxygen supplementation) were assigned to receive either HBO2 treatment or the standard treatment for respiratory symptoms for 7 days. HBO2 treatment was planned for ≥5 sessions (1 /day) for 90 min at 1.45 atmosphere absolute (ATA). Outcomes were time to normalise oxygen requirement to SpO2 ≥93%, need for mechanical respiratory assistance, development of acute respiratory distress syndrome and mortality within 30 days. A sample size of 80 patients was estimated, with a planned interim analysis after determining outcomes on 50% of patients.ResultsThe trial was stopped after the interim analysis. 40 patients were randomised, 20 in each group, age was 55.2±9.2 years. At admission, frequent symptoms were dyspnoea, fever and odynophagia; SpO2 was 85.1%±4.3% for the whole group. Patients in the treatment group received an average of 6.2±1.2 HBO2 sessions. Time to correct hypoxaemia was shorter in treatment group versus control group; median 3 days (IQR 1.0–4.5) versus median 9 days (IQR 5.5–12.5), respectively (p<0.010). OR for recovery from hypoxaemia in the HBO2 group at day 3 compared with the control group was 23.2 (95% CI 1.6 to 329.6; p=0.001) Treatment had no statistically significant effect on acute respiratory distress syndrome, mechanical ventilation or death within 30 days after admission.ConclusionOur findings support the safety and efficacy of HBO2 in the treatment of COVID-19 and severe hypoxaemia.Trial registration numberNCT04477954.

Hyperbaric oxygen therapy for patients with COVID-19

“…The study by Cannellotto and colleagues1 balanced many factors relating to COVID-19 so as to be maximally safe for the enroled participants. The authors selected a very low treatment pressure, 1.45 ATA, and by doing so attempted to minimise any haemodynamic risks for the enroled patients.…”

How to Restore Oxidative Balance That Was Disrupted by SARS-CoV-2 Infection

“…More oxygen is dissolved in plasma in high-pressure environments. HBOT therapy was applied in COVID-19 patients with severe hypoxia and proved to be more efficient in correcting saturation compared to standard therapy [ 33 ]. Hyperoxia induced by HBOT seems to decrease pro-inflammatory cytokines through the inhibition of nuclear factor kappa B (NF-κB), which induces the expression of pro-inflammatory genes [ 34 ].…”

Prevention and Treatment of Life-Threatening COVID-19 May Be Possible with Oxygen Treatment

“…Some studies specifically describe patients reporting the prompt resolution of labored breathing following a single HBOT treatment [ 81 , 82 , 83 , 84 , 85 ]. In one very recent study, aimed at becoming RCT-compatible, it was possible to correct severe hypoxemia with mild HBOT (0.45 ATA overpressure) in three days compared with nine days in the controls [ 86 ]. The elevation of the pressure by 0.45 ATA (corresponding to an altitude of 2400 m) is equal to that used in airplanes prophylactically to correct potentially fatal hypobaria.…”

“…The authors of COVID-19-HBOT studies conclude in common that well-defined RCT-compatible clinical trials are urgently needed [ 82 , 83 , 84 , 85 , 86 ]. However, designing such a trial may be difficult.…”