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

Phase 2

• Conditions: COVID-19Nitric Oxide Treatment; C01.925.782.600.550.200; D01.339.387; VS3.003.001.006

• Registration Number: RBR-8nfx26
• Lead Sponsor: Pontifícia Universidade Católica do Rio Grande do Sul - PUCRS

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-09-22
• Study Completion: 2021-12-31
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: Not specified
• Target Recruitment: Not specified

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

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.

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Measures

Name	Time	Method
Clinical score recorded daily at 8 am<br>;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)