Nitric Oxide Inhalation Therapy for COVID-19 Infections in the ED

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

Summary

The spread of novel Coronavirus (2019-nCoV) related infection (COVID-19) has led to many patient presentations in the emergency department for respiratory complaints, with many of these patients requiring ICU admission and ventilatory support. While COVID-19 patients have an increased need for supportive care, there is currently no specific treatment directed against 2019-nCoV. Nitric oxide inhalation has been used as a pulmonary vasodilator and has been found to have antiviral activity against other coronavirus strains. The primary aim of this study is to determine whether inhaled NO improves short term respiratory status, prevents future hospitalization, and improves the clinical course in patients diagnosed with COVID-19 specifically in the emergency department.

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

Details

• Lead Sponsor: Massachusetts General Hospital
• Collaborators: Department of Anesthesia, Critical Care and Pain Medicine (DACCPM), Massachusetts General Hospital; Department of Anesthesia, MGH
• Treatments: Nitric Oxide

Criteria

Inclusion Criteria:

• Age ≥ 18 years old

• Presentation to the ED with respiratory symptoms likely caused by COVID-19

• Patient displays at least one of the following

1. respiratory rate ≥ 24

2. new cough

3. new atypical chest pain

4. new dyspnea

5. oxygen saturation < 97% at rest

6. chest x-ray with new changes consistent with COVID-related airspace disease

• Cleared for discharge home by attending physician

• Obtained COVID testing (results not required at time of enrollment)

• Onset of symptoms ≤12 days prior to ED visit

Exclusion Criteria:

• Attending physician estimation (< 50% likelihood) of other more likely non-COVID etiology

• Presence of tracheostomy

• Requirement of oxygen therapy to maintain resting oxygen saturation of > 94%

• Clinical contraindication to use of inhaled nitric oxide