COVID-19 Nitric Oxide Treatment
Conditions
Interventions
Protocol A
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
Sponsors
Pontifícia Universidade Católica do Rio Grande do Sul - PUCRS
Conselho Nacional de Desenvolvimento Científico e Tecnológico - CNPq
Eligibility
Age
10 Years to 100 Years
Inclusion criteria
Inclusion criteria: Protocol A 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). Protocol B Non hospitalized patients with proven or high suspicion of coronavirus infection; signing a consent form and/or assent; older than 10 years. Score clinical 2 (at home with limitations).
Exclusion criteria
Exclusion criteria: Protocol A Participant in any other clinical trial of an experimental treatment for COVID-19; pregnancy; clinical contraindication of the attending physician; use of a nitric oxide donor agent, such as nitroglycerin or drugs known to increase methaemoglobin, such as lidocaine, prilocaine, benzocaine or dapsone; heart failure, left ventricular dysfunction; history of hemoptysis. Protocol B Participant in any other clinical trial of an experimental treatment for COVID-19; Pregnancy; clinical contraindication of the attending physician; indication for hospitalization at the time of evaluation; use of a nitric oxide donor agent, such as nitroglycerin or drugs prepared by increasing methemoglobin, such as lidocaine, prilocaine, benzocaine, or dapsone; heart failure, left ventricular dysfunction; hx of hemoptysis.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Clinical score recorded daily at 8 am ;PCR negative for SARS-CoV-2 at discharge or after 5 \ days;Inflammatory markers in plasma, obtained on day 0 and day 5;Mortality in 30 and 60 days;Proportion of patients who progress to severe disease (respiratory failure, septic shock or multiple organ failure) | — |
Countries
Brazil
Contacts
Public ContactMarcus Jones
PUCRS
Outcome results
None listed