Introduction: COVID may cause severe pneumonitis and trigger a massive inflammatory response that requires ventilatory support. Dexamethasone is the only of all anti-inflammatory drugs that have been tested to date that has shown a positive effect on mortality. Our hypothesis is that HBO can prevent ICU admission, morbidity and mortality by attenuating the inflammatory response.
Methods and analysis: A randomised, controlled, phase II, open label, multicentre trial. Baseline clinical data and blood samples will be collected before randomisation and repeated daily for 7 days, at days 14 and Subjects will be randomised with a computer-based system to HBO, maximum five times during the first 7 days plus best practice treatment or only best practice treatment.
All parameters are recorded in an electronic case report form. An independent Data Safety Monitoring Board will review the safety parameters. Positive, negative and any inconclusive results will be published in peer-reviewed scientific journals with open access. Trial registration: NCT EudraCT number: Re-use permitted under CC BY. Published by BMJ. Abstract Introduction: COVID may cause severe pneumonitis and trigger a massive inflammatory response that requires ventilatory support.
Substances Pharmaceutical Preparations. Associated data ClinicalTrials.
