Nitric Oxide Gas Inhalation Therapy for Mild/Moderate COVID-19 (NoCovid)
Coronavirus Infections, Pneumonia, Viral, Acute Respiratory Distress Syndrome
About this trial
This is an interventional treatment trial for Coronavirus Infections focused on measuring COVID-19, ARDS, Mechanical Ventilation, Nitric Oxide
Eligibility Criteria
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.
Exclusion Criteria:
- 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
Sites / Locations
- Providence HealthCare Network
- Louisiana State University Health Shreveport
- Massachusetts General Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
No Intervention
Experimental
Nitric Oxide inhalation
Control
Nitric Oxide Inhalation (Non-Randomized)
Nitric Oxide will be delivered through a non invasive CPAP system (with minimal pressure support to decrease discomfort due to the facial mask) or through a non-rebreathing mask system.
Patients assigned to the control group will not receive any gas therapy.
All subjects part of this arm will receive nitric oxide gas either as an inpatient or outpatient. Nitric Oxide will be delivered through a non invasive CPAP system (with minimal pressure support to decrease discomfort due to the facial mask) or through a non-rebreathing mask system. Patients in this arm will not be randomized, so that all patients receive the study medication.