COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04305457

Lorenzo Berra, MD

lberra@mgh.harvard.edu

2020-03-12

Not recruiting

RCT

Randomized

Parallel

Open label

multi-center

Treatment

inclusion criteria: laboratory confirmed covid19 infection defined with a positive rt-pcr from any specimen and/or detection of sars-cov-2 igm/igg antibodies. hospital admission with at least one of the following: fever ≥ 36.6 °c from axillary site; or ≥ 37.2°c from oral site; or ≥ 37.6°c from tympanic or rectal site. respiratory rate ≥ 24 bpm cough spontaneous breathing with or without hypoxia of any degree. gas exchange and ventilation maybe assisted by any continuous continuous airway pressure (cpap), or any system of non invasive ventilation (niv), with positive end-expiratory pressure (peep) ≤ 10 cmh2o.

tracheostomy therapy with high flow nasal cannula any clinical contraindications, as judged by the attending physician patients enrolled in another interventional study hospitalized and confirmed diagnosis of covid-19 for more than 72 hours previous intubation for covid-19 patient not committed to full support (dnr, dni or cmo) patient requiring oxygen at home for lung comorbidities primary cause of hopitalization not due to covid-19

2

Massachusetts General Hospital

18

None

United States

Mild/moderate disease at enrollment

2: Mild/moderate disease at enrollment

70

Reduction in the incidence of patients with mild/moderate COVID-19 requiring intubation and mechanical ventilation

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"}]