Nitric Oxide Gas Inhalation Therapy for Mild/Moderate COVID19 Infection

• Status: Withdrawn
• Trial end date: 2022-02-01
• 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 (COVID-19) 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 COVID-19 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: Xijing Hospital
• Collaborators: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico; Massachusetts General Hospital
• Treatments: Nitric Oxide

Criteria

Inclusion Criteria:

1. Laboratory confirmed COVID19 infection defined with a positive RT-PCR from any specimen.

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

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

• Respiratory rate ≥ 24 bpm

• 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.

4. ≤ 8 days since onset of the symptoms

Exclusion Criteria:

1. Pregnancy, or positive pregnancy test in a predose examination

2. Open tracheostomy

3. Therapy with high flow nasal cannula

4. Clinical controindication, as deemed by the attending physician