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Nitric Oxide Inhalation Therapy for COVID-19 Infections in the ED (NO COV-ED)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04338828
Recruitment Status : Recruiting
First Posted : April 8, 2020
Last Update Posted : May 20, 2020
Sponsor:
Collaborator:
Department of Anesthesia, MGH
Information provided by (Responsible Party):
N. Stuart Harris MD MFA, Massachusetts General Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
COVID19 Drug: Nitric Oxide Gas Other: Inhaled Supplemental Oxygen Phase 2

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 260 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Nitric Oxide Inhalation Therapy for COVID-19 Infections in the Emergency Department
Actual Study Start Date : April 18, 2020
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : April 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Treatment Group
Inhaled nitric oxide
 Drug: Nitric Oxide Gas
Inhaled NO administered at target inspired concentration 140 - 300 ppm for 20-30 minutes
Placebo Comparator: Control Group
Inhaled supplemental oxygen
 Other: Inhaled Supplemental Oxygen
2 L/min oxygen therapy


Outcome Measures
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Primary Outcome Measures :
  1. Rates of return visits to the ED [ Time Frame: 28 days ]
    Difference within treatment and control groups with COVID-related symptoms/disease in their likelihood to return to the ED with worsening symptoms


Secondary Outcome Measures :
  1. Inpatient hospitalizations required [ Time Frame: 28 days ]
    Difference within treatment and control groups with COVID-related symptoms/disease in their likelihood to require hospitalization during their COVID-19 course

  2. Rates of intubation [ Time Frame: 28 days ]
    Difference within treatment and control groups with COVID-related symptoms/disease in their likelihood to require intubation during their COVID-19 course

  3. Rates of mortality [ Time Frame: 28 days ]
    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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04338828


Contacts
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Contact: N. Stuart Harris, MD, MFA 617-724-3290 nsharris@mgh.harvard.edu

Locations
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United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: N. Stuart Harris, MD, MFA    617-724-3290    nsharris@mgh.harvard.edu   
Sponsors and Collaborators
Massachusetts General Hospital
Department of Anesthesia, MGH
More Information
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Responsible Party: N. Stuart Harris MD MFA, Principal Investigator, Division Chief of Wilderness Medicine, Department of Emergency Medicine, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT04338828    
Other Study ID Numbers: 2019P00XXXX
First Posted: April 8, 2020    Key Record Dates
Last Update Posted: May 20, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by N. Stuart Harris MD MFA, Massachusetts General Hospital:
inhaled nitric oxide
emergency department
emergency medicine
respiratory infection
Additional relevant MeSH terms:
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Infection
Nitric Oxide
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
 Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Endothelium-Dependent Relaxing Factors
Vasodilator Agents
Gasotransmitters
Protective Agents