Respiratory Tract InfectionsPhase 2NCT03331445
Inhaled Gaseous Nitric Oxide (gNO) Antimicrobial Treatment of Difficult Bacterial and Viral Lung (COVID-19) Infections
A Phase 2 study testing Nitric Oxide 0.5 % / Nitrogen 99.5 % Gas for Inhalation in people with Respiratory Tract Infections and Corona Virus Infection, run by Chris Miller at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Respiratory Tract Infections, Corona Virus Infection
- What is being tested?
- Nitric Oxide 0.5 % / Nitrogen 99.5 % Gas for Inhalation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteCanada
- Study dates
- 24 Oct 2017to 30 Jun 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- Has an FEV1 ≥ 30 % of predicted. c. Suspected corona-like viral infection
- Oxygen saturation on room air >92% at screening.
- 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.
Who cannot join
- 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;
Show all 25Show fewer
- 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
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the detailed description
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,
- as confirmed by no unanticipated adverse events
- Absence of a deleterious mean change in FEV1% predicted (absolute) from baseline
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.
- as confirmed by an improvement in pre-treatment bacterial colonization and post-treatment bacterial colonization on Days 19 and 26 as compared to baseline.
Efficacy will be assessed by change in Quality of Life Score.
- as assessed by an improvement in CRISS Score on Day 5, 19 and 26 as compared to baseline measurement;
- as determined by improvement in six-minute walk test with one minute recovery as compared to baseline measurement.
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:
- Proportion of patients with mild COVID2019 who deteriorate to a severe form of the disease requiring mechanical intervention like BIPAP/CPAP, intubation and mechanical ventilation;
- Mortality from all causes during the study period;
- Negative conversion of COVID-19 RT-PCR from upper respiratory tract measured as the proportion of patients with a negative conversion of RT-PCR from an oropharyngeal or a nasopahryngeal swab;
- Time to clinical recovery defined as the time from initiation of the study to discharge or to normalization of fever (defined as <36.6°C from axillary site, or < 37.2°C from oral site or < 37.8°C from rectal or tympanic site), respiratory rate (< 24 bpm while breathing room air);
- Alleviation of symptoms recorded in the Modified Jackson Cols score with particular definition of cough (defined as mild or absent in a patient reported scale of severity).
- Being tested
- Nitric Oxide 0.5 % / Nitrogen 99.5 % Gas for Inhalation
- Keywords
- inhaled nitric oxide, non tuberculous mycobacteria, drug resistant pneumonia, Burkholderia, Aspergillus, COVID-19, Viral Envelope Proteins, SARS-COV-2
- Medical subject headings
- Respiratory Tract Infections, Coronavirus Infections, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nitric Oxide 0.5 % / Nitrogen 99.5 % Gas for InhalationDrug
Also called Thiolanox
Inhaled Nitric Oxide 160ppm balance air
| Study group | Role | What they receive |
|---|---|---|
| 160 ppm Nitric Oxide | Experimental | Not described Receives: Drug: Nitric Oxide 0.5 % / Nitrogen 99.5 % Gas for Inhalation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 26 Days
Secondary outcomes (3)
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
Measured: 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
Measured: 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)
Measured: Day 19 and 26
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2017
- Study start24 Oct 2017
- Primary completion30 Jun 2021
- Study completion30 Jun 2021
Why it stopped: Covid Incidence too low and Funding Completed
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Respiratory Tract InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Model description
- Open label safety study (COVID-19 Sub-study)
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chris Miller
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Mallinckrodt
- Responsible party
- Sponsor-investigator, Chris Miller, Nitric Solutions Inc.
- Investigators
- Jeremy D Road, MD, Principal investigator, MD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03331445
- Sponsor's protocol ID
- NTM-CTP-01: H17-02107
- Status last verified
- Jul 2021
- First submitted
- 25 Oct 2017
- Last updated
- 16 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Deppisch C, Herrmann G, Graepler-Mainka U, Wirtz H, Heyder S, Engel C, Marschal M, Miller CC, Riethmuller J. Gaseous nitric oxide to treat antibiotic resistant bacterial and fungal lung infections in patients with cystic fibrosis: a phase I clinical study. Infection. 2016 Aug;44(4):513-20. doi: 10.1007/s15010-016-0879-x. Epub 2016 Feb 9.
PubMed 26861246Miller C, Miller M, McMullin B, Regev G, Serghides L, Kain K, Road J, Av-Gay Y. A phase I clinical study of inhaled nitric oxide in healthy adults. J Cyst Fibros. 2012 Jul;11(4):324-31. doi: 10.1016/j.jcf.2012.01.003. Epub 2012 Apr 18.
PubMed 22520076Yaacoby-Bianu K, Gur M, Toukan Y, Nir V, Hakim F, Geffen Y, Bentur L. Compassionate Nitric Oxide Adjuvant Treatment of Persistent Mycobacterium Infection in Cystic Fibrosis Patients. Pediatr Infect Dis J. 2018 Apr;37(4):336-338. doi: 10.1097/INF.0000000000001780.
PubMed 28885458
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03331445
- Acronym / sponsor ID
- NTM-CTP-01: H17-02107
- Keywords
- inhaled nitric oxide, non tuberculous mycobacteria, drug resistant pneumonia, Burkholderia, Aspergillus, COVID-19, Viral Envelope Proteins, SARS-COV-2
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Covid Incidence too low and Funding Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Chris MillerIndustry (pharma, biotech, devices)
- Collaborators
- Mallinckrodt
- Study start
- 24 Oct 2017 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 6 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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,
- as confirmed by no unanticipated adverse events
- Absence of a deleterious mean change in FEV1% predicted (absolute) from baseline
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.
- as confirmed by an improvement in pre-treatment bacterial colonization and post-treatment bacterial colonization on Days 19 and 26 as compared to baseline.
Efficacy will be assessed by change in Quality of Life Score.
- as assessed by an improvement in CRISS Score on Day 5, 19 and 26 as compared to baseline measurement;
- as determined by improvement in six-minute walk test with one minute recovery as compared to baseline measurement.
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:
- Proportion of patients with mild COVID2019 who deteriorate to a severe form of the disease requiring mechanical intervention like BIPAP/CPAP, intubation and mechanical ventilation;
- Mortality from all causes during the study period;
- Negative conversion of COVID-19 RT-PCR from upper respiratory tract measured as the proportion of patients with a negative conversion of RT-PCR from an oropharyngeal or a nasopahryngeal swab;
- Time to clinical recovery defined as the time from initiation of the study to discharge or to normalization of fever (defined as <36.6°C from axillary site, or < 37.2°C from oral site or < 37.8°C from rectal or tympanic site), respiratory rate (< 24 bpm while breathing room air);
- Alleviation of symptoms recorded in the Modified Jackson Cols score with particular definition of cough (defined as mild or absent in a patient reported scale of severity).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Open label safety study (COVID-19 Sub-study)
| Arm | Type | Receives |
|---|---|---|
| 160 ppm Nitric Oxide | Experimental | Drug: Nitric Oxide 0.5 % / Nitrogen 99.5 % Gas for Inhalation |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Written informed consent.
- Has been previously diagnosed with NTM, Burkholderia spp and Aspergillus spp. or Corona-like viral infection:
- 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
Key exclusion criteria (25 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nitric Oxide 0.5 % / Nitrogen 99.5 % Gas for InhalationAlso: ThiolanoxInhaled Nitric Oxide 160ppm balance air | Drug | 160 ppm Nitric Oxide |
Primary outcome
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
3 secondary outcomes
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 antimicrobial effect of 160ppm inhaled nitric oxide on lung NTM bacterial load in the sputum
Time frame: Day 19 and 26
Measure the effect of 160ppm inhaled nitric oxide on Quality of Life (CRISS) Score
Time frame: Day 19 and 26
Results and safety
The study was stopped early (reason given: Covid Incidence too low and Funding Completed). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2021.
- Background: PubMed 26861246Deppisch C, Herrmann G, Graepler-Mainka U, Wirtz H, Heyder S, Engel C, Marschal M, Miller CC, Riethmuller J. Gaseous nitric oxide to treat antibiotic resistant bacterial and fungal lung infections in patients with cystic fibrosis: a phase I clinical study. Infection. 2016 Aug;44(4):513-20. doi: 10.1007/s15010-016-0879-x. Epub 2016 Feb 9.
- Background: PubMed 22520076Miller C, Miller M, McMullin B, Regev G, Serghides L, Kain K, Road J, Av-Gay Y. A phase I clinical study of inhaled nitric oxide in healthy adults. J Cyst Fibros. 2012 Jul;11(4):324-31. doi: 10.1016/j.jcf.2012.01.003. Epub 2012 Apr 18.
- Background: PubMed 28885458Yaacoby-Bianu K, Gur M, Toukan Y, Nir V, Hakim F, Geffen Y, Bentur L. Compassionate Nitric Oxide Adjuvant Treatment of Persistent Mycobacterium Infection in Cystic Fibrosis Patients. Pediatr Infect Dis J. 2018 Apr;37(4):336-338. doi: 10.1097/INF.0000000000001780.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeremy D Road, MD principal investigator
MD
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nitric Oxide 0.5 % / Nitrogen 99.5 % Gas for Inhalation in people with Respiratory Tract Infections and Corona Virus Infection, run by Chris Miller at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 16 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Covid Incidence too low and Funding Completed). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure the safety of 160ppm inhaled nitric oxide delivery in NTM subjects (time frame: 26 Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03331445, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2021.