The purpose of this open label, 2-phase, study is to obtain information on the safety of 80 ppm and the safety and efficacy of 150 ppm Nitric Oxide given in addition to the standard of care of patients with COVID-19 caused by SARS-CoV-2.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Nitric Oxide delivered via LungFit system. Patients will receive inhalations of 150 ppm for 40 minutes 4 time per day plus standard supportive care.
Nitric Oxide delivered via LungFit system. Patients will receive inhalations of 80 ppm for 40 minutes 4 time per day plus standard supportive care.
Time to deterioration
Time to deterioration as measured by any one of the following: * need for non-invasive ventilation * need for high flow nasal cannula (HFNC) or * need for intubation * Death from any cause
Time frame: up to 14 days
Time to stable oxygen saturation
Time to patient having stable oxygen saturation (SpO2) of greater than 92% for longer than 3 hr on room air
Time frame: up to 14 days
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