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

NCT ID: NCT04338828

Last Updated: 2022-01-06

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 47 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-04-18
• Study Completion Date: 2021-03-01

Brief 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.

Detailed 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.

Conditions

COVID19

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Treatment Group

Inhaled nitric oxide

Group Type: EXPERIMENTAL

Nitric Oxide Gas

Intervention Type: DRUG

Inhaled NO administered at target inspired concentration 140 - 300 ppm for 20-30 minutes

Control Group

Inhaled supplemental oxygen

Group Type: PLACEBO_COMPARATOR

Inhaled Supplemental Oxygen

Intervention Type: OTHER

2 L/min oxygen therapy

Interventions

Nitric Oxide Gas

Inhaled NO administered at target inspired concentration 140 - 300 ppm for 20-30 minutes

Intervention Type: DRUG

Inhaled Supplemental Oxygen

2 L/min oxygen therapy

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

N. Stuart Harris MD MFA

Principal Investigator, Division Chief of Wilderness Medicine, Department of Emergency Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

2019P00XXXX

Identifier Type: -

Identifier Source: org_study_id