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

COVID19 Clinical Trial

— NO COV-ED  

Official title:

Nitric Oxide Inhalation Therapy for COVID-19 Infections in the Emergency Department

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04338828
• Other study ID #: 2019P00XXXX
• Status: Terminated
• Phase: Phase 2
• Start date: April 18, 2020
• Est. completion date: March 1, 2021

Study information

• Verified date: December 2021
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Preliminary data support a microbicidal effect of high concentration inhaled NO. We hypothesize that high concentration inhaled NO can have a viricidal effect against SARS-Cov-2 and prevent the deterioration to a severe form of COVID-19 when administered at an early stage of the disease. Additional potential mechanisms why INO may be effective in this indication: 1)improves V/Q ratio, 2) reduces PVR and PAP, 3) Anti-thrombotic in lung. This would have potential benefit for the patients in terms of reducing the severity of the clinical course and time to recovery. An additional benefit could be for the society since a faster and a less severe clinical course could protect limited hospital resources (ED, floor, and ICU) from being overwhelmed.

The primary aim is to prevent the deterioration of mild COVID-19 infection (defined by a RT-PCR positive for SARS-CoV-2 in a specimen from any site) with respiratory signs/ symptoms to a more severe form of the disease as defined by the patient needing to 1) return to the ED, 2) be admitting to the hospital, 3) be intubated, 4) and all cause 28 day mortality.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 47
• Est. completion date: March 1, 2021
• Est. primary completion date: January 14, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• COVID19
• Infections

Intervention

Drug:
• Nitric Oxide Gas
Inhaled NO administered at target inspired concentration 140 - 300 ppm for 20-30 minutes

Other:
• Inhaled Supplemental Oxygen
2 L/min oxygen therapy

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rates of return visits to the ED	Difference within treatment and control groups with COVID-related symptoms/disease in their likelihood to return to the ED with worsening symptoms	28 days
Secondary	Inpatient hospitalizations required	Difference within treatment and control groups with COVID-related symptoms/disease in their likelihood to require hospitalization during their COVID-19 course	28 days
Secondary	Rates of intubation	Difference within treatment and control groups with COVID-related symptoms/disease in their likelihood to require intubation during their COVID-19 course	28 days
Secondary	Rates of mortality	Difference within treatment and control groups with COVID-related symptoms/disease in their likelihood to die of any cause within 28 days of their initial ED visit	28 days