COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04425031

Bodil Steen Rasmussen

Not reported

2020-06-11

Not recruiting

RCT

Randomized

Parallel

Blind label

multi-center

Treatment

inclusion criteria: - acutely admitted to the icu and - aged ≥ 18 years and - receives supplemental oxygen with a flow of at least 10 l per minutes in an open system including high-flow systems or recieves supplemental oxygen in a closed system including invasive or non-invasive ventilation or continuous positive airway pressure (cpap)-systems and - expected to receive supplemental oxygen for at least 24 hours in the icu and - having an arterial line for pao2 monitoring and - confirmed severe acute respiratory syndrome coronavirus 2 (sars-cov-2) infection (covid-19) in the time leading to or during current hospital admission

- cannot be randomised within twelve hours after present icu admission - chronic mechanical ventilation for any reason - use of home oxygen - previous treatment with bleomycin - organ transplant during current hospital admission - withdrawal from active therapy or brain death deemed imminent - fertile woman (< 50 years of age) with positive urine human gonadotropin (hcg) or plasma-hcg - carbon monoxide poisoning - cyanide poisoning - methaemoglobinaemia - paraquat poisoning - any condition expected to involve the use of hyperbaric oxygen (hbo) - sickle cell disease - consent not obtainable according to national regulations - previously randomised into the hot-covid trial

2

Aalborg University Hospital

18

100

Denmark;Norway;Switzerland

Critical disease at enrollment

8: Critical disease at enrollment

726

Days alive without organ support

None

Phase 4

[{"arm_notes": "", "treatment_id": 943, "treatment_name": "Oxygen", "treatment_type": "Gas inhalation", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "", "treatment_id": 943, "treatment_name": "Oxygen", "treatment_type": "Gas inhalation", "pharmacological_treatment": "Non pharmacological treatment"}]