A Phase 2 interventional study of Nitric Oxide 0.5 % / Nitrogen 99.5 % Gas for Inhalation in Respiratory Tract Infections and Corona Virus Infection, sponsored by Chris Miller. Terminated at 1 site in Canada. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2021-07-16.
Sponsored by Chris Miller · Phase 2, Interventional, and Treatment
Among 11 studies testing Nitric Oxide in COVID-19 — none open to participants now, none under way, none of them phase 3. Nitric Oxide · COVID-19.
Among the 11 studies testing Nitric Oxide in COVID-19, this one is the 8th largest by enrollment, is the only one that started in 2017, is one of 7 in phase 2, and was the 1st registered.
7,990 studies on the registry are indexed under COVID-19; 466 are open to participants now.
Browse COVID-19 studies →None of the 11 studies testing Nitric Oxide in COVID-19 is open now. The open studies under COVID-19, anywhere →
Nitric Oxide: first FDA approval 1999 (INOMAX), first EMA approval 2001. What it is approved for, and how studies give it, is on its page →
Of the 356 COVID-19 studies recruiting now, 207 (58%) set no upper age limit and 83 (23%) stop at 75 or younger; 91 take children under 18; 136 take healthy volunteers.
This study: 19 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
11 studies; the count open now beside each. This study's row is marked.
First in 2017; this study’s year is marked. 1 started in 2017.
This study's enrollment of 13 is below the median of 102 across 4,364 interventional studies indexed under COVID-19.
Median enrollment 47 across the 11 interventional studies. Of the 9 that completed or were terminated, 4 (44%) have results posted.
This tab as a report to print or save as PDF → With an account.
4 of 11 have an industry lead sponsor. The 8 most frequent:
This is the only study on the registry with Chris Miller as lead sponsor.
Chris Miller has 1 study filed under COVID-19 — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 11 studies testing Nitric Oxide in COVID-19, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
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.
Main Study
Primary Objective: Assess the safety of inhaled NO (gNO) in adults \& adolescents with NTM, Burkholderia, Aspergillus Lung Infections and Viral Lung (COVID-19) Infections
Safety will be evaluated by unanticipated adverse events in clinical labs (hematology, coagulation, and serum chemistries); in vitals; in inspired concentration of NO, O2 and NO2 delivered to each subject and; in real time methemoglobin and oxygen saturation levels.
Primary Endpoint:
Determine the safety of gNO in the NTM population,
Secondary safety Endpoint: Determine the efficacy of inhaled NO in adults with NTM, Burkholderia and Aspergillus Lung Infections
Efficacy will be evaluated by measuring the change in lung function with spirometry (specifically absolute change in FEV1 % predicted) from baseline to Days 5, 12, 19 and 26.
Secondary Efficacy Endpoint Determine the presence of an efficacy signal of gNO in the NTM, Burkholderia and Aspergillus Lung Infections
Efficacy will be assessed by the antimicrobial effect of inhaled NO on the density of NTM species and other microorganisms in sputum. Serial measurements of these microbial colony counts in sputum have been previously used as a measure of antimicrobial activity in other clinical trials of antibiotics in NTM.
Efficacy will be assessed by change in Quality of Life Score.
COVID-19 Substudy
Primary Endpoint:
Efficacy will be evaluated by measuring reduction in the incidence of mechanical assistance of BIPAP, CPAP, intubation and mechanical ventilation during the study period.
Secondary Endpoints:
7,990 studies on the registry are indexed under COVID-19; 466 are open to participants now.
This study's enrollment of 13 is below the median of 102 across 4,364 interventional studies indexed under COVID-19.
Browse COVID-19 studies →This is the only study on the registry with Chris Miller as lead sponsor.
Compared within COVID-19, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Respiratory Tract Infections. The counts are of registry records indexed under each term, refreshed daily. How we classify →
COVID SubStudy Inclusion Criteria
Exclusion Criteria
Recruitment on hold for following Criteria during COVID-19 Pandemic
Inclusion Criteria:
Has been previously diagnosed with NTM, Burkholderia spp and Aspergillus spp. or Corona-like viral infection:
Oxygen saturation on room air >92% at screening.
a. Able to breathe without supplemental oxygen for 60 minutes
Exclusion Criteria:
For women of child bearing potential:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
FEV1
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Nitric Oxide 0.5 % / Nitrogen 99.5 % Gas for Inhalation
Drug page: Nitric Oxide
Inhaled Nitric Oxide 160ppm balance air
Also known as: Thiolanox
Measure the safety of 160ppm inhaled nitric oxide delivery in NTM subjects
Measure the number of unanticipated adverse events over the duration of the study protocol
Time frame: 26 Days
Measure the effect of 160ppm inhaled nitric oxide delivery on lung spirometry in NTM subjects
Measure the change in absolute FEV1.0 change from baseline during 160 ppm inhalation therapy
Time frame: Day 5,12,19 and 26
Measure the antimicrobial effect of 160ppm inhaled nitric oxide on lung NTM bacterial load in the sputum
Measure the difference from baseline NTM species bacterial load (0 to +4) in sputum during 160ppm nitric oxide inhalation therapy
Time frame: Day 19 and 26
Measure the effect of 160ppm inhaled nitric oxide on Quality of Life (CRISS) Score
Measure the difference from baseline CRISS (0-100) during 160ppm nitric oxide inhalation therapy (lower score represents higher quality of life)
Time frame: Day 19 and 26
Sub-Study Primary Endpoint(s): Efficacy to reduce respiratory interventions
Measuring reduction in the incidence of mechanical assistance including oxygen therapy, BIPAP, CPAP, intubation and mechanical ventilation during the study period.
Time frame: Day 26
Efficacy in reduction of mortality
Measured by death from all causes
Time frame: Day 26
Antiviral effect
Assessed by time to negative conversion of COVID-19 RT-PCR from upper respiratory tract
Time frame: Day 26
Efficacy on clinical improvement
Time to clinical recovery as measured by resolution of clinical signs
Time frame: Day 26
Efficacy on the respiratory symptoms
Measured by change in the Modified Jackson Cold Score
Time frame: Day 26
Plan to share: No
Ran from Oct 2017 to primary completion in Jun 2021, 44 months.
How these figures are worked out, and which studies are left out of them.
This study is terminated, as verified in Jul 2021. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Nitric Oxide