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

NCT04338828 | Terminated Phase 2 DMC FDA Drug

• 1 other identifier: 2019P00XXXX
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID19

Keywords

inhaled nitric oxide; emergency department; emergency medicine; respiratory infection

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Inpatient hospitalizations required

  28 days

• Rates of intubation

  28 days

• Rates of mortality

  28 days

Study Arms (2)

Treatment Group

EXPERIMENTAL

Inhaled nitric oxide

Drug: Nitric Oxide Gas

Control Group

PLACEBO COMPARATOR

Inhaled supplemental oxygen

Other: Inhaled Supplemental Oxygen

Interventions

Nitric Oxide Gas DRUG

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

Treatment Group

Inhaled Supplemental Oxygen OTHER

2 L/min oxygen therapy

Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years old
• Presentation to the ED with respiratory symptoms likely caused by COVID-19
• Patient displays at least one of the following
• respiratory rate ≥ 24
• new cough
• new atypical chest pain
• new dyspnea
• oxygen saturation \< 97% at rest
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

COVID-19; Emergencies; Respiratory Tract Infections

Interventions

Endothelium-Dependent Relaxing Factors

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Vasodilator Agents; Cardiovascular Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Division Chief of Wilderness Medicine, Department of Emergency Medicine

Study Record Dates

• First Submitted: April 5, 2020
• First Posted: April 8, 2020
• Study Start: April 18, 2020
• Primary Completion: January 14, 2021
• Study Completion: March 1, 2021
• Last Updated: January 6, 2022

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)