COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04306393

Lorenzo Berra, MD

lberra@mgh.harvard.edu

2020-03-12

Completed

RCT

Randomized

Parallel

Blind label

multi-center

Treatment

inclusion criteria: (1) adult patients, >/= 18 year-old; (2) patients admitted to the icu; (3) patients who are intubated and mechanically ventilated; (4) confirmed diagnosis of sars-cov2 by positive rt-pcr.

(1) patients intubated for more than 72 hours from initiation of the treatment gas; (2) subjects enrolled in another interventional research study; (3) physician of record opposed to enrolling the patient due to perceived safety concerns; or any condition that does not allow the protocol to be followed safely; (4) subjects with past medical history of lung malignancy or pneumonectomy or lung transplant; (5) subjects receiving a tidal volume < 3 cc/kg of ideal body weight at the time of enrollment; (6) subjects with severe burns involving more than 40% of total body surface area; (7) subjects that have experienced cardiac arrest with cpr for longer than 30 minutes; (8) subjects with a presumed severe deficit in cerebral function with fixed dilated pupil; (9) subjects receiving renal replacement therapy at the time of enrollment; (10) subjects who have an impaired ability to ventilate without assistance; (11) subjects who have a history of malignancy or other irreversible disease/conditions with a 6-month mortality > 50%; (12) subjects not fully committed to full support at the time of enrollment; (13) subject receiving inhaled nitric oxide gas prior to enrollment; (14) subject's hospital admission unrelated to covid-19.

2

Massachusetts General Hospital

18

99

Sweden;United States

Severe disease at enrollment

6: Severe disease at enrollment

200

Change of arterial oxygenation at 48 hours from enrollment

None

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"}]