Nitric Oxide Gas Inhalation Therapy for Mild/Moderate COVID-19

• Status: Active, not recruiting
• Trial end date: 2022-04-01
• Target enrollment: 0
• Participant gender: All

Summary

The scientific community is in search for novel therapies that can help to face the ongoing epidemics of novel Coronavirus (SARS-Cov-2) originated in China in December 2019. At present, there are no proven interventions to prevent progression of the disease. Some preliminary data on SARS pneumonia suggest that inhaled Nitric Oxide (NO) could have beneficial effects on SARS-CoV-2 due to the genomic similarities between this two coronaviruses. In this study we will test whether inhaled NO therapy prevents progression in patients with mild to moderate COVID-19 disease.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Massachusetts General Hospital
• Collaborators: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico; University of Alabama at Birmingham; Xijing Hospital
• Treatments: Nitric Oxide

Criteria

Inclusion Criteria:

1. Laboratory confirmed COVID19 infection defined with a positive RT-PCR from any specimen and/or detection of SARS-CoV-2 IgM/IgG antibodies.

2. Hospital admission with at least one of the following:

1. fever ≥ 36.6 °C from axillary site; or ≥ 37.2°C from oral site; or ≥ 37.6°C from tympanic or rectal site.

2. Respiratory rate ≥ 24 bpm

3. cough

3. Spontaneous breathing with or without hypoxia of any degree. Gas exchange and ventilation maybe assisted by any continuous continuous airway pressure (CPAP), or any system of Non Invasive Ventilation (NIV), with Positive End-Expiratory Pressure (PEEP) ≤ 10 cmH2O.

Exclusion Criteria:

1. Tracheostomy

2. Therapy with high flow nasal cannula

3. Any clinical contraindications, as judged by the attending physician

4. Patients enrolled in another interventional study

5. Hospitalized and confirmed diagnosis of COVID-19 for more than 72 hours

6. Previous intubation for COVID-19

7. Patient not committed to full support (DNR, DNI or CMO)

8. Patient requiring oxygen at home for lung comorbidities

9. Primary cause of hopitalization not due to COVID-19