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 range

18 Years

Sex

ALL

See this in plain English?

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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

View on ClinicalTrials.gov More Hypoxemia trials