Inhaled Gaseous Nitric Oxide (gNO) Antimicrobial Treatment of Difficult Bacterial and Viral Lung (COVID-19) Infections
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ClinicalTrials.gov Identifier: NCT03331445 |
Recruitment Status :
Terminated
(Covid Incidence too low and Funding Completed)
First Posted : November 6, 2017
Last Update Posted : July 16, 2021
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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 |

Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 13 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 |
Actual Primary Completion Date : | June 30, 2021 |
Actual Study Completion Date : | June 30, 2021 |

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 |
- 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
- 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
- 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
- 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)
- 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.
- Efficacy in reduction of mortality [ Time Frame: Day 26 ]Measured by death from all causes
- Antiviral effect [ Time Frame: Day 26 ]Assessed by time to negative conversion of COVID-19 RT-PCR from upper respiratory tract
- Efficacy on clinical improvement [ Time Frame: Day 26 ]Time to clinical recovery as measured by resolution of clinical signs
- Efficacy on the respiratory symptoms [ Time Frame: Day 26 ]Measured by change in the Modified Jackson Cold Score

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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:
- 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:
- 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:
- positive pregnancy test at screening or
- lactating or
- 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.

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): NCT03331445
Canada, British Columbia | |
Nitric Solutions-Mobile Unit | |
Vancouver, British Columbia, Canada, V7H2Y4 |
Principal Investigator: | Jeremy D Road, MD | MD |
Responsible Party: | Chris Miller, CSO, Nitric Solutions Inc. |
ClinicalTrials.gov Identifier: | NCT03331445 |
Other Study ID Numbers: |
NTM-CTP-01: H17-02107 |
First Posted: | November 6, 2017 Key Record Dates |
Last Update Posted: | July 16, 2021 |
Last Verified: | July 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
inhaled nitric oxide non tuberculous mycobacteria drug resistant pneumonia Burkholderia |
Aspergillus COVID-19 Viral Envelope Proteins SARS-COV-2 |
Infections Communicable Diseases Respiratory Tract Infections Coronavirus Infections Disease Attributes Pathologic Processes 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 Antioxidants Molecular Mechanisms of Pharmacological Action Neurotransmitter Agents Endothelium-Dependent Relaxing Factors Vasodilator Agents Gasotransmitters Protective Agents |