COVID-19Phase 1NCT04383002
High Dose Inhaled Nitric Oxide for COVID-19 (ICU Patients)
A Phase 1 study testing Nitric Oxide in people with COVID-19, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
Novel therapies are desperately needed for treatment of COVID-19 patients. At present, there are no proven interventions to prevent progression of the disease or to rapidly treat patients with COVID-19 related respiratory failure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19
- What is being tested?
- Nitric Oxide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteCanada
- Study dates
- 2 Sep 2020to 11 Jun 2021
- Phase
- Phase 1
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Confirmed infection with COVID-19 positive RT-PCR tracheal aspirate prior to treatment
- Use of mechanical ventilation with or without ECMO
- Male or female ages > 18 years
- < 14 days from symptom initiation to study enrolment and < 7 days from intubation to study enrolment
Who cannot join
- Patients on other interventional clinical trials
- Subjects diagnosed with congestive or unstable heart disease including heart failure, left ventricular dysfunction (LVEF < 40 %) or myocardial damage, severe pulmonary hypertension and/or unstable hypertension
- Subjects diagnosed with immunodeficiency
- Hematology: patients with clinically significant anemia e.g. Hemoglobin < 100 and thrombocytopenia e.g. Platelets < 75
- Subjects with clinically significant history of, or active bleeding including active pulmonary or gastrointestinal bleeding
- Hepatic Function: Patients with abnormal liver function defined as any two of the following ALT >3x ULN, AST >3x ULN, Total bilirubin < 1.5 X ULN
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- Patient receiving drugs that have a contraindication with NO e.g. use of a nitric oxide donor agent such as nitroglycerin or drugs known to increase methemoglobin such as lidocaine, prilocaine, benzocaine or dapsone at screening as relevant to the proposed study population
- Pregnancy
- Subjects with a known hypersensitivity to methylene blue, subjects with glucose-6-phosphate dehydrogenase (G6PD) deficiency
- Known or suspected thalassemia, sickle cell disease, or other conditions associated with poor oxygen carrying capacity
Trial locations and contacts
1 site in 1 country.
Canada1 site
University Health Network, Toronto General Hospital
Toronto, Ontario, M5G 2C4
About this study
Official title: Use of High Dose Inhaled Nitric Oxide in Intubated Patients Admitted With COVID-19
Novel therapies are desperately needed for treatment of COVID-19 patients. At present, there are no proven interventions to prevent progression of the disease or to rapidly treat patients with COVID-19 related respiratory failure. Data on the original coronavirus -SARS pneumonia suggested that high dose (>160ppm) inhaled Nitric Oxide could have beneficial effects also on COVID-19, due to the genomic similarities between these two coronaviruses (1-3). This study will test whether high dose inhaled nitric oxide is safe and can reverse virus burden and respiratory failure in patients on mechanical ventilation.
- Conditions
- COVID-19
- Being tested
- Nitric Oxide
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nitric OxideDrug
iNO will be given at 160ppm for 6 hours, once a day, for 2 days
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care (control) | No intervention | Patients will receive standard of care therapy |
| Inhaled Nitric Oxide | Experimental | Not described Receives: Drug: Nitric Oxide |
What is being measured
The primary outcome is the main question the study is designed to answer.
COVID-19 PCR status at completion of treatment (day 7) from tracheal aspirate
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2020
- Study start2 Sep 2020
- Primary completion11 May 2021
- Study completion11 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marcelo Cypel, MD, Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04383002
- Sponsor's protocol ID
- 20-5449
- Status last verified
- May 2021
- First submitted
- 1 May 2020
- Last updated
- 11 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of High Dose Inhaled Nitric Oxide in Intubated Patients Admitted With COVID-19
- ClinicalTrials.gov ID
- NCT04383002
- Acronym / sponsor ID
- 20-5449
- Conditions
- COVID-19
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- 2 Sep 2020 (actual)
- Primary completion
- 11 May 2021 (actual)
- Study completion
- 11 Jun 2021 (actual)
- First posted
- 11 May 2020 (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.
Novel therapies are desperately needed for treatment of COVID-19 patients. At present, there are no proven interventions to prevent progression of the disease or to rapidly treat patients with COVID-19 related respiratory failure. Data on the original coronavirus -SARS pneumonia suggested that high dose (>160ppm) inhaled Nitric Oxide could have beneficial effects also on COVID-19, due to the genomic similarities between these two coronaviruses (1-3). This study will test whether high dose inhaled nitric oxide is safe and can reverse virus burden and respiratory failure in patients on mechanical ventilation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of Care (control) | No intervention | –Patients will receive standard of care therapy |
| Inhaled Nitric Oxide | Experimental | Drug: Nitric Oxide |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Confirmed infection with COVID-19 positive RT-PCR tracheal aspirate prior to treatment
- Use of mechanical ventilation with or without ECMO
- Male or female ages > 18 years
- < 14 days from symptom initiation to study enrolment and < 7 days from intubation to study enrolment
Key exclusion criteria (10 listed)
- Patients on other interventional clinical trials
- Subjects diagnosed with congestive or unstable heart disease including heart failure, left ventricular dysfunction (LVEF < 40 %) or myocardial damage, severe pulmonary hypertension and/or unstable hypertension
- Subjects diagnosed with immunodeficiency
- Hematology: patients with clinically significant anemia e.g. Hemoglobin < 100 and thrombocytopenia e.g. Platelets < 75
- Subjects with clinically significant history of, or active bleeding including active pulmonary or gastrointestinal bleeding
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 OxideiNO will be given at 160ppm for 6 hours, once a day, for 2 days | Drug | Inhaled Nitric Oxide |
Primary outcome
COVID-19 PCR status at completion of treatment (day 7) from tracheal aspirate
Time frame: 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2022.
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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.
Marcelo Cypel, MD principal investigator
University Health Network, Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Nitric Oxide in people with COVID-19, run by University Health Network, Toronto 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 4 inclusion and 10 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: finished, as of the sponsor's last update on 11 Apr 2022. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
COVID-19 PCR status at completion of treatment (day 7) from tracheal aspirate (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Apr 2022.