A Randomized, Controlled, Open Label, Multicentre Clinical Trial to Explore Safety and Efficacy of Hyperbaric Oxygen for Preventing ICU Admission, Morbidity and Mortality in Adult Patients With COVID-19
Main objective: To evaluate if HBO reduce the number of ICU admissions compared to Best practice for COVID-19
Main secondary objectives:
To evaluate if HBO:
– reduces mortality in severe cases of COVID-19.
– reduces morbidity associated with COVID-19.
– reduce the load on ICU resources in COVID-19.
– mitigate the inflammatory reaction in COVID-19.
Other secondary objectives (in selection):
To evaluate if HBO is safe for SARS-CoV-2 positive patients and staff.
Study design: Randomized, controlled, phase II, open label, multicentre
Study population: Adult patients with SARS-CoV-2 infection, with at least two risk factor for increased mortality, likely to develop ARDS criteria and need intubation within 7 days of admission to hospital.
Number of subjects: 200 (20+180)
Investigational product: Hyperbaric oxygen (HBO) compared with best practice treatment HBO:
HBO 1.6-2.4 ATA for 30-60 min, maximum 5 treatments first 7 days Control: Best practice treatment for COVID-19
SARS (Severe Acute Respiratory Syndrome)
May 8, 2020
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