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Trial record 1 of 2 for:    NCT03331445
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Inhaled Gaseous Nitric Oxide (gNO) Antimicrobial Treatment of Difficult Bacterial and Viral Lung (COVID-19) Infections

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. Identifier: NCT03331445
Recruitment Status : Recruiting
First Posted : November 6, 2017
Last Update Posted : September 9, 2020
Information provided by (Responsible Party):
Chris Miller, Nitric Solutions Inc.

Brief Summary:
Non tuberculous mycobacteria (NTM), Burkholdria spp, Aspergillus in the lung are almost impossible to eradicate with conventional antibiotics. In addition COVID-19 has know current treatment. These patients have few options to treat their lung infection. Nitric oxide has broad bactericidal and virucidal properties. It has been shown that nitric oxide was safe to be inhaled for similar cystic fibrosis patients and reduced drug resistant bacteria in the lungs. Further, research indicates that clinical isolates of NTM, Burkholderia spp, Aspergillus spp and Corona-like viruses can be eradicated by 160ppm NO exposure in the laboratory petri dish. This is not the first time inhaled NO treatment has been used in patients with difficult lung infections. This study will provide more data to see if NO therapy can reduce the bacterial load in the lungs, help the patients breath better; and in the case of COVID-19 act as a anti-viral agent resulting in the reduction of incidence of oxygen therapy, mechanical assistance of BIPAP, CPAP, intubation and mechanical ventilation during the study period.

Condition or disease Intervention/treatment Phase
Respiratory Tract Infections Corona Virus Infection Drug: Nitric Oxide 0.5 % / Nitrogen 99.5 % Gas for Inhalation Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Sequential Assignment
Intervention Model Description: Open label safety study (COVID-19 Sub-study)
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open Label Safety Study of Inhaled Gaseous Nitric Oxide (gNO) for Adults & Adolescents With Non-Tuberculous Mycobacteria, Burkholderia Spp, Aspergillus Spp and Corona-like Viral (Sub-Study) Infections
Actual Study Start Date : October 24, 2017
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : March 31, 2021

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 160 ppm Nitric Oxide Drug: Nitric Oxide 0.5 % / Nitrogen 99.5 % Gas for Inhalation
Inhaled Nitric Oxide 160ppm balance air
Other Name: Thiolanox

Primary Outcome Measures :
  1. Measure the safety of 160ppm inhaled nitric oxide delivery in NTM subjects [ Time Frame: 26 Days ]
    Measure the number of unanticipated adverse events over the duration of the study protocol

Secondary Outcome Measures :
  1. Measure the effect of 160ppm inhaled nitric oxide delivery on lung spirometry in NTM subjects [ Time Frame: Day 5,12,19 and 26 ]
    Measure the change in absolute FEV1.0 change from baseline during 160 ppm inhalation therapy

  2. Measure the antimicrobial effect of 160ppm inhaled nitric oxide on lung NTM bacterial load in the sputum [ Time Frame: Day 19 and 26 ]
    Measure the difference from baseline NTM species bacterial load (0 to +4) in sputum during 160ppm nitric oxide inhalation therapy

  3. Measure the effect of 160ppm inhaled nitric oxide on Quality of Life (CRISS) Score [ Time Frame: Day 19 and 26 ]
    Measure the difference from baseline CRISS (0-100) during 160ppm nitric oxide inhalation therapy (lower score represents higher quality of life)

Other Outcome Measures:
  1. Sub-Study Primary Endpoint(s): Efficacy to reduce respiratory interventions [ Time Frame: Day 26 ]
    Measuring reduction in the incidence of mechanical assistance including oxygen therapy, BIPAP, CPAP, intubation and mechanical ventilation during the study period.

  2. Efficacy in reduction of mortality [ Time Frame: Day 26 ]
    Measured by death from all causes

  3. Antiviral effect [ Time Frame: Day 26 ]
    Assessed by time to negative conversion of COVID-19 RT-PCR from upper respiratory tract

  4. Efficacy on clinical improvement [ Time Frame: Day 26 ]
    Time to clinical recovery as measured by resolution of clinical signs

  5. Efficacy on the respiratory symptoms [ Time Frame: Day 26 ]
    Measured by change in the Modified Jackson Cold Score

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

COVID SubStudy Inclusion Criteria

  • Capable of understanding and providing signed informed consent and ability to adhere to the requirements and restrictions of this protocol;
  • Men and Women ≥ 19 years of age unless local laws dictate otherwise;
  • English speaking;
  • Suspected of exposure to SARS-CoV-2 with fatigue and at least a fever (>37.90 C) or cough or sore throat or a positive swab for SAR-CoV-2 within 5 days of the of enrollment;
  • Must be willing to use an adequate form of contraception (or abstinence) from the time of the first dose with the IMP until after the last dose of IMP.

Exclusion Criteria

  • Prior Tracheostomy;
  • Concomitant treatment involving high flow nasal cannula;
  • Any clinical contraindications, as judged by the attending physician;
  • Mentally or neurologically disabled patients who are considered not fit to consent to their participation in the study;
  • Prior COVID-19 infection or a positive swab for SARS-CoV-2 greater than 5 days from enrollment;
  • Family members in the same household already on the study;
  • Hydroxychloroquine, colchicine and other experimental antiviral medications;
  • unwilling to practice a medically acceptable form of contraception from screening to Day 26 (acceptable forms of contraception: abstinence, hormonal birth control, intrauterine device, or barrier method plus a spermicidal agent).

Recruitment on hold for following Criteria during COVID-19 Pandemic

Inclusion Criteria:

  • Written informed consent.
  • Has been previously diagnosed with NTM, Burkholderia spp and Aspergillus spp. or Corona-like viral infection:

    1. NTM, Burkholderia spp and Aspergillus spp defined as positive culture(s) of at least one species of Mycobacterium avium Complex (MAC) or Mycobacterium abscessus Complex (MABSCor Burkholderia spp and Aspergillus spp) or Corona-like viral infection:
    2. History of repeatedly positive cultures (2 or more), irregardless of therapy
  • Male or female ≥14 years of age.
  • Female not pregnant at time of study.
  • Has an FEV1 ≥ 30 % of predicted. c. Suspected corona-like viral infection
  • Oxygen saturation on room air >92% at screening.

    a. Able to breathe without supplemental oxygen for 60 minutes

  • Non-smoker for at least 6 months prior to screening and agrees not to smoke during the study.
  • Willing and able to comply with the treatment schedule and procedures.

Exclusion Criteria:

  • Use of an investigational drug within 30 days of screening
  • History of frequent epistaxis (>1 episode/month)
  • Significant hemoptysis within 30 days (≥ 5 mL of blood in one coughing episode or > 30 mL of blood in a 24 hour period)
  • History of reactive pulmonary vascular hypertension
  • Methemoglobin >3% at screening
  • Liver function insufficiency (ALT/ AST >3 of normal values)
  • Hemoglobin <11 g/dl
  • Thrombocytopenia (platelet count <100,000/mm3) at screening
  • Prothrombin time international ratio (INR) > 1.3 at screening
  • Changes to antibiotics (e.g. azithromycin) from 7 days prior to screening through last treatment day. (Subjects may be taking antibiotics or antivirals during this time period, but they cannot start, stop or change doses during this time period)
  • On supplemental oxygen during gNO treatment (SaO2 < 90% for 50 minutes while resting in a chair).
  • For women of child bearing potential:

    1. positive pregnancy test at screening or
    2. lactating or
    3. unwilling to practice a medically acceptable form of contraception from screening to Day 36 (acceptable forms of contraception: abstinence, hormonal birth control, intrauterine device, or barrier method plus a spermicidal agent)
  • Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.

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 identifier (NCT number): NCT03331445

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Contact: Chris C Miller, Ph.D. 778-899-0607

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Canada, British Columbia
Nitric Solutions-Mobile Unit Recruiting
Vancouver, British Columbia, Canada, V7H2Y4
Contact: Chris C Miller, Ph.D    778-899-0607   
Sponsors and Collaborators
Chris Miller
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Principal Investigator: Jeremy D Road, MD MD
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Responsible Party: Chris Miller, CSO, Nitric Solutions Inc. Identifier: NCT03331445    
Other Study ID Numbers: NTM-CTP-01: H17-02107
First Posted: November 6, 2017    Key Record Dates
Last Update Posted: September 9, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Chris Miller, Nitric Solutions Inc.:
inhaled nitric oxide
non tuberculous mycobacteria
drug resistant pneumonia
Viral Envelope Proteins
Additional relevant MeSH terms:
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Communicable Diseases
Respiratory Tract Infections
Coronavirus Infections
Severe Acute Respiratory Syndrome
Respiratory Tract Diseases
Virus Diseases
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Nitric Oxide
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Free Radical Scavengers
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Endothelium-Dependent Relaxing Factors
Vasodilator Agents
Protective Agents