CompletedPhase 1/2

Nitric Oxide Therapy for COVID-19 Patients With Oxygen Requirement

Russia20 participantsStarted 2020-07-24

Plain-language 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 antiviral effect of NO against SARS-coronavirus. The optimal therapeutic regimen of NO gas in spontaneously breathing hypoxemic patients with COVID-19 is not known. We hypothesize that high concentration inhaled NO with an adjunct of continuous low dose administration between the high concentration treatments can be safely administered in hypoxemic COVID-19 patients compared to the high dose treatment alone. Prolonged administration of NO gas may benefit the patients in terms of the severity of the clinical course and time to recovery. Together with a clinical effect on ventilation-perfusion matching, a prolonged regimen would allow also an increase in antiviral activity (dose and time-dependent).

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Change in Methemoglobin level at 48 hours

Timeframe: 48 hours

Trial details

NCT IDNCT04476992

SponsorTomsk National Research Medical Center of the Russian Academy of Sciences

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-07-17