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Hyperbaric Oxygen Therapy for COVID-19 Patients: A Prospective, Randomized Controlled Trial
27 Pages Posted: 9 Apr 2021More...
Introduction: The hallmarks of pulmonary derangement due to severe COVID-19 disease include hypoxemia and a dysregulated and excessive immune response, i.e. a "cytokine storm". Several case series reported on the beneficial effect of hyperbaric oxygen therapy (HBOT) on COVID-19 patients. The aim of the current study was to evaluate the effects of HBOT on COVID-19 patients using a prospective randomized controlled design.
Methods: Thirty-one severe COVID-19 inpatients, suffering from respiratory insufficiency in addition to at least one other risk factor, were randomized to HBOT or a control arms in a 2:1 ratio. Patients underwent baseline evaluations which included symptoms questionnaire, vital signs and blood tests. The HBOT arm patients underwent eight HBOT sessions twice daily. The evaluation was repeated on day 5, the day after the last HBOT session.
Results: Compared to the control group, one day following the last HBOT session, there was a significant increase in room air saturation in the HBOT patients (F=15·269, p=0·001), significant improvement in the NEWS severity score (F=16·379, p=0·001) and a decreased respiratory rate (F=15·269, p=0·001). There was a significant decrease in CRP and LDH in the HBOT group compared to the control group (CRP: F=5·322, p=0·032, LDH: F=5·599, p=0·027) and a significantly higher proportion developed COVID-19 IgG antibodies compared to the control group (p<0·001).
Conclusion: This study demonstrates, for the first time in a prospective randomized clinical trial, that HBOT is a safe therapeutic modality that can improve oxygenation, attenuate inflammation and improve the clinical status of severely ill COVID-19 patients. Larger scale studies are needed to evaluate the effect on inpatient mortality.
Trial Registration: The study was registered at clinicaltrials.gov NCT04358926.
Funding Statement: The study was supported by the research fund of Shamir
Declaration of Interests: Amir Hadanny, Yair Bechor, Yonatan Zemel work for AVIV Scientific
LTD., Shai Efrati is a shareholder at AVIV Scientific LTD., all other authors have nothing to disclose.
Ethics Approval Statement: This study was approved by the Institutional Review Board (IRB) at Shamir Medical Center and the Israeli National Review Board.
Suggested Citation: Suggested Citation