Covid 19 Clinical Trials

	Name (Synonyms)	Correlation
D000860	Hypoxia NIH	0.21
D011024	Pneumonia, Viral NIH	0.12
D011014	Pneumonia NIH	0.06
D045169	Severe Acute Respiratory Syndrome NIH	0.05
D018352	Coronavirus Infections NIH	0.04

Correlated HPO Terms (2)

	Name (Synonyms)	Correlation
HP:0012418	Hypoxemia HPO	0.21
HP:0002090	Pneumonia HPO	0.06

There is one clinical trial.

Clinical Trials

1 A Safety Study on the Use of Intermittent Versus Continuous Inhalation of NO in Spontaneous Breathing COVID-19 Patients

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).

NCT04476992 Hypoxemia Pneumonia, Viral Coronavirus Infection Drug: Nitric Oxide-Sessions Drug: Nitric Oxide-Continuous and Sessions

MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Pneumonia, Viral Pneumonia Hypoxia

HPO:Hypoxemia Pneumonia

Primary Outcomes

Description: The primary outcome will be evaluated with the difference in Methemoglobin levels between the groups at 48 hours after randomization.

Measure: Change in Methemoglobin level at 48 hours

Time: 48 hours

Secondary Outcomes

Description: The primary outcome will be evaluated with the difference in Methemoglobineamia between the groups at 96 hours after randomization.

Measure: Change in Methemoglobin level at 96 hours

Time: 96 hours

Description: The secondary outcome, "Improve the oxygenation at 48 hours," will be evaluated with the measure of the difference in oxygenation among the groups at 48 hours. Oxygenation will be measured in terms of the SpO2/FiO2 ratio.

Measure: Improvement in oxygenation between the groups at 48 hours or at discharge if before 48 hours

Time: 48 hours

Description: The secondary outcome, "Improve the oxygenation at 96 hours," will be evaluated with the measure of the difference in oxygenation between the groups at 96 hours. Oxygenation will be measured in terms of the SpO2/FiO2 ratio.

Measure: Improvement in oxygenation between the groups at 96 hours or at discharge if before 96 hours

Time: 96 hours

Description: The secondary outcome "difference in the rate of negative RT-PCR for SARS CoV-2" will be evaluated as the rate of negativization of the RT-PCR for SARS-CoV-2 at 5 days after randomization, at discharge and at 28 days after randomization.

Measure: Rate of positive RT-PCR for SARS-CoV-2 between groups in 5 days, discharge, and 28 days

Time: 28 days

Description: The secondary outcome "different time to clinical recovery" will be evaluated as the time between the randomization and the clinical indication to interrupt the administration of oxygen for 24 hours.

Measure: Time to clinical recovery among groups, defined as time to interruption of oxygen administration for 24 hours or discharge

Time: 28 days

Description: The secondary outcome "Different reduction in inflammatory markers" will be evaluated as improvement in the inflammatory markers (IL-6; Ferritin; White Blood Cells; Leucocyte count; CRP; D-Dimer) observed in blood samples collected at day 1, 2, 3, 4, and 7 compared to the Baseline value.

Measure: Reduction in the inflammatory markers among groups

Time: 7 days

Description: The secondary outcome "rate of AKI between groups" will be evaluated as the presence of a comparable rate of AKI during the hospital stay. The AKI will be defined according to the KDIGO classification.

Measure: Rate of Acute Kidney Disease (AKI) between groups during hospitalization

Time: 28 days

Description: The secondary outcome "Difference in Katz score between groups" will be evaluated as the difference in Katz Activities of Daily Living between Baseline and day 28. This questionnaire will coincide with the 28-day phone call to assess health status and survival.

Measure: Difference in Katz score between groups

Time: 28 days

Other Outcomes

Description: 1. The exploratory outcome "Effect of nitric oxide on heart function in COVID-19 hypoxemic patients" will be evaluated as: the changes observed in heart ultrasound at 48 and 96 hours (or at discharge) compared to the Baseline in all groups. the changes observed in heart ultrasound during the administration of NO comparing pre-treatment, during treatment, and post-treatment.

Measure: Effect of NO gas treatment on cardiovascular hemodynamics assessed using cardiac ultrasound in COVID-19 hypoxemic patients

Time: 96 hours

Description: 2. The secondary outcome "Effect of NO gas on lung function in COVID-19 hypoxemic patients" will be evaluated as: the changes observed in spirometry at 48 and 96 hours (or at discharge) compared to the Baseline in all groups. the changes observed in spirometry during the administration of NO comparing pre-treatment, during treatment, and post-treatment.

Measure: Effect of NO gas treatment on lung function evaluated with serial spirometry in COVID-19 hypoxemic patients

Time: 96 hours