Nitric Oxide Gas Inhalation Therapy for Mild/Moderate COVID-19

NCT04305457 | Terminated Phase 2 Results FDA Drug

• 1 other identifier: NOgas mildCOVID-19
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 2

Brief Summary

The scientific community is in search for novel therapies that can help to face the ongoing epidemics of novel Coronavirus (SARS-Cov-2) 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 SARS-CoV-2 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.

Conditions

Coronavirus Infections; Pneumonia, Viral; Acute Respiratory Distress Syndrome

Keywords

COVID-19; ARDS; Mechanical Ventilation; Nitric Oxide

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Mild/Moderate COVID-19 Requiring Intubation and Mechanical Ventilation

  The primary outcome will be the number of participants requiring intubation and mechanical ventilation, as a marker of deterioration from a mild to a severe form of COVID-19. Patients with indication to intubation and mechanical ventilation but concomitant DNI (Do Not Intubate) or not intubated for any other reason external to the clinical judgment of the attending physician will be considered as meeting the criteria for the primary endpoint.

  28 days

Secondary Outcomes (2)

• Mortality

  28 days

• Time to Clinical Recovery

  28 days

Other Outcomes (1)

• Negative Conversion of COVID-19 RT-PCR From Upper Respiratory Tract

  7 days

Study Arms (2)

Nitric Oxide inhalation

EXPERIMENTAL

Nitric Oxide will be delivered through a non invasive CPAP system (with minimal pressure support to decrease discomfort due to the facial mask) or through a non-rebreathing mask system.

Drug: Nitric Oxide

Control

NO INTERVENTION

Patients assigned to the control group will not receive any gas therapy.

Interventions

Nitric Oxide DRUG

Nitric Oxide (NO) will be delivered together with the standard of care for a period of 20-30 minutes 2 times per day for 14 consecutive days from time of enrollment. Targeted No inhaled concentration will be maintained between 140 and 180 ppm. The gas will be delivered through a CPAP circuit ensuring an end-expiratory pressure between 2 and 10 cmH2O or through a non-rebreathing mask without positive end-expiratory pressure, depending on the clinical needs of the subject.

Also known as: Nitric Oxide inhalation

Nitric Oxide inhalation

Eligibility Criteria

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

You may qualify if:

• Laboratory confirmed COVID19 infection defined with a positive RT-PCR from any specimen and/or detection of SARS-CoV-2 IgM/IgG antibodies.
• 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
• 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.

You may not qualify if:

• Tracheostomy
• Therapy with high flow nasal cannula
• Any clinical contraindications, as judged by the attending physician
• Patients enrolled in another interventional study
• Hospitalized and confirmed diagnosis of COVID-19 for more than 72 hours
• Previous intubation for COVID-19
• Patient not committed to full support (DNR, DNI or CMO)
• Patient requiring oxygen at home for lung comorbidities
• Primary cause of hopitalization not due to COVID-19

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• University of Alabama at Birmingham: collaborator

Study Sites (2)

Louisiana State University Health Shreveport

Shreveport, Louisiana, 71103, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114-2621, United States

Location

MeSH Terms

Conditions

Coronavirus Infections; Pneumonia, Viral; Respiratory Distress Syndrome; COVID-19

Interventions

Nitric Oxide

Condition Hierarchy (Ancestors)

Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Intervention Hierarchy (Ancestors)

Reactive Nitrogen Species; Free Radicals; Inorganic Chemicals; Nitrogen Oxides; Nitrogen Compounds; Oxides; Oxygen Compounds; Organic Chemicals

Results Point of Contact

• Title: Lorenzo Berra, MD
• Organization: Massachusetts General Hospital

lberra@mgh.harvard.edu

617-726-3030

Study Officials

• Lorenzo Berra, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Model Details: This study includes a randomized, parallel arm clinical trial in which subjects will be randomized to receive either inhaled nitric oxide (in addition to the standard of care) or the standard of care alone.

Study Record Dates

• First Submitted: March 9, 2020
• First Posted: March 12, 2020
• Study Start: March 21, 2020
• Primary Completion: August 23, 2023
• Study Completion: August 23, 2023
• Last Updated: March 23, 2026
• Results First Posted: March 23, 2026

Record last verified: 2026-03

Locations

US (2)