COVID-19 trials registries data warehouse

https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-001656-18/NO

Oslo University Hospital - Air Ambulance Department

cbuskop@ous-hf.no

2020-04-24

Recruiting

RCT

Randomized

Parallel

Blind label

single-center

Treatment

All criteria must apply Patients ≥ 18 years of age at the time of inclusion and who are confirmed, suspected or probable cases of covid-19 based on WHO definitions and SpO2 <90% after 3 minutes 10 cm H2O PEEP + 100% O2 and who are treated by a physician who have specifically undergone formal training in pre-hospital INO administration and the present protocol.

Only one criterion needs to apply for exclusion: 1. Patients who after 3 mins of ventilation with 10 cm H2O PEEP + 100% O2 i.e. at time of allocation (t0), have a SpO2 <50%, or a reliable SpO2 is impossible to obtain 2. Patients in severe kidney failure or dialysis, 3. Known or suspected pregnancy based on information on the time of inclusion. 4. Hypersensitivity to the active substance (NO) or to the excipient (N2) 5. Cardiac arrest 6. Patient in prison or custody by police 7. Staff present in treatment situation known to be pregnant 8. Any reason why, in the opinion of the treating physician, it is probably in the best interest of the patient not to participate in the trial. Female participants under the age of 50 years will be asked explicitly about possible pregnancy. If this cannot be obtained from the patient, next of kin will be asked if present. Information regarding exclusion criteria 2, 3 and 4 will be obtained from bystanders, often relatives or friends present at time of inclusion. If no clear information is available, the physicians shall include or exclude based on his/her best judgment at the time of inclusion.

2

Oslo University Hospital

18

100

Norway

Severe/critical disease at enrollment

7: Severe/critical disease at enrollment

54

The primary outcome measure is the change in SpO2, and the null hypothesis is that there is no difference in the change in SpO2 following initiation of INO

Declared number of arm (2.0) differs from found arms (1.0)

Phase 2

[{"arm_notes": "", "treatment_id": 890, "treatment_name": "Nitric oxide gas", "treatment_type": "Gas inhalation", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]