A randomized controlled study on the safety and efficacy of microhyperbaric oxygen therapy in patients with severe COVID-19 infection

Introduction: COVID-19 pandemic remains an acute global emergency. The situation was especially worrying in mainland China. However, paxlovid shortage led to the underuse of recommended antivirus treatment. Hyperbaric oxygen therapy (HBOT) could increase SpO 2 in COVID-19 patients with severe hypoxemia. The prior trials suggested this potential effectiveness while the study design and sample size may not be sufficient in illustrating the effectiveness and safety of HBOT. Therefore, we designed the current protocol to examine the hypothesis that HBO may improve disease severity and decrease mortality after infection. Methods and analysis: This study is an open-label randomized controlled trial. A total of 40 COVID-19 patients with disease progression scale 5 or higher will be randomly assigned to control group or HBOT group. The control group will receive usual care according to the latest guidelines of the centers of disease control and prevention for COVID-19. Besides the usual care, the patients in HBOT group will receive 7 low-pressure (1.6 atmosphere absolute) HBOT sessions in consecutive 7 days. The primary outcome was defined as World Health Organization clinical progression scale difference before and after the seven-day study. Secondary outcomes include pulse oximetry value at the end of study; duration of hospitalization; newly developed COVID-related symptoms or comorbidity; serum inflammatory biomarks; chest imaging improvement; and HBOT associated adverse events.