Nitric Oxide Therapy for COVID-19 Patients With Oxygen Requirement

Launched by TOMSK NATIONAL RESEARCH MEDICAL CENTER OF THE RUSSIAN ACADEMY OF SCIENCES · Jul 16, 2020

Keywords

ClinConnect Summary

Coronavirus disease 2019 (COVID-19) consists mainly of a respiratory infection that spans from a mild involvement of the upper respiratory tract to severe pneumonia leading to respiratory distress, shock, and death. Fever, cough, and dyspnea/tachypnea, together with myalgia and fatigue, have been identified as the most common presenting symptoms. Most of the patients remain in a state of mild upper respiratory tract disease for a relatively long period (a median of 8-10 days), after which a proportion of up to 25% may develop severe hypoxemia and ARDS with the necessity of mechanical ventil...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • COVID-19 confirmed by a positive RT-PCR test
• • Hospital admission within 11 days from the onset of symptoms
• • Spontaneous breathing with oxygen requirement ≥1 L/min
• • Expected discharge \> 96 hours at randomization
• Exclusion Criteria:
• • Pregnancy
• • Presence of a tracheostomy
• • Assistance by any non-invasive CPAP or NIV at the screening
• • Treatment with high flow nasal cannula at the screening
• • Clinical contraindication to the use of NO
• • Patients enrolled in another interventional trial
• • Hospitalized and confirmed diagnosis of COVID-19 for more than 7 days
• • Previous intubation for COVID-19
• • Subject not committed to full support (DNR, DNI or CMO)
• • Subject requiring oxygen at home for lung comorbidities
• • The primary cause of hospitalization not due to COVID-19
• • Subject receiving vasopressor at the time of screening
• • History of malignancy or other irreversible disease/conditions with 6-month mortality \>50%
• • Oxygen saturation of 100% at screening, despite oxygen requirement
• • Patients on dialysis at the time of enrollment