Effect of Inhaled Nitric Oxide for the treatment of COVID-19

Category Primary study
Registry of TrialsBrazilian Registry of Clinical Trials
Year 2020
INTERVENTION: Drug Experimental group: 55 participants with high clinical suspicion and / or medical diagnostic confirmation of COVID‐19 will receive nitric oxide inhalation at 160 parts per million (ppm) for 6 hours in the first 48 hours of hospitalization, single or fractional dose. The subjects will be followed up to 60 days after being included in this study. Control Group: 55 participants with high clinical suspicion and/or medical diagnostic confirmation of COVID‐19 will be selected for follow‐up and will receive only conventional treatment as stipulated by the local medical team. The subjects will be followed up to 60 days after being included in this study. Nitric Oxide CONDITION: C01.925.782.600.550.200 COVID‐19 COVID‐19 ; COVID‐19 D01.339.387 VS3.003.001.006 PRIMARY OUTCOME: It is expected to evaluate the days without respiratory support (supplemental oxygen, CNAF, NIV, VM, ECMO) in 15 days. A live day without respiratory support was defined as any day on which the patient did not receive supplemental oxygen or invasive or non‐invasive mechanical ventilation, from randomization to the 15th. Considering an average of 11 days and a standard deviation of 5 days in free days of ventilatory support, 110 patients (55 for each arm) will be sufficient to detect an average difference of 3 days between the study groups (experimental vs control), with 80% power and a two‐tailed alpha of 0, 05. A value of 0 will be assigned to patients who died during the 15‐day window. SECONDARY OUTCOME: Clinical score recorded daily at 8 am ; Inflammatory markers in plasma, obtained on day 0 and day 5 Mortality in 30 and 60 days PCR negative for SARS‐CoV‐2 at discharge or after 5 \ days Proportion of patients who progress to severe disease (respiratory failure, septic shock or multiple organ failure) INCLUSION CRITERIA: Hospitalized patients with proven or high suspicion of coronavirus infection; signing a consent form and/or assent; older than 10 years. Score clinical 4 (receiving supplemental oxygen).
Epistemonikos ID: 4801a16cc86655c82b2b89e6329621acf540847a
First added on: Oct 09, 2020