Status:
COMPLETED
Nitric Oxide Therapy for COVID-19 Patients With Oxygen Requirement
Lead Sponsor:
Tomsk National Research Medical Center of the Russian Academy of Sciences
Collaborating Sponsors:
Siberian State Medical University
Conditions:
Hypoxemia
Pneumonia, Viral
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
Preliminary data support the effect of Nitric Oxide (NO) on improving the oxygenation in mechanically ventilated patients and spontaneously breathing patients with COVID-19. In vitro studies showed an...
Detailed Description
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, sh...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 24 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 17 2021
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04476992
Start Date
July 24 2020
End Date
September 17 2021
Last Update
January 26 2023
Active Locations (1)
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1
Cardiology Research Institute, Tomsk National Research Medical Center, Russian Academy of Sciences
Tomsk, Russia, 634012