HypoxemiaPhase 1/2NICORNCT04476992
Nitric Oxide Therapy for COVID-19 Patients With Oxygen Requirement
A Phase 1/2 study testing Nitric Oxide-Sessions and Nitric Oxide-Continuous and Sessions in people with Hypoxemia and Pneumonia, Viral, run by Tomsk National Research Medical Center of the Russian Academy of Sciences at 1 site in Russia.
Trial summary
Preliminary data support the effect of Nitric Oxide (NO) on improving the oxygenation in mechanically ventilated patients and spontaneously breathing patients with COVID-19. In vitro studies showed an antiviral effect of NO against SARS-coronavirus. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypoxemia, Pneumonia, Viral, Coronavirus Infection
- What is being tested?
- Nitric Oxide-Sessions and Nitric Oxide-Continuous and Sessions
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteRussia
- Study dates
- 24 Jul 2020to 17 Sep 2021
- Phase
- Phase 1/2
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- COVID-19 confirmed by a positive RT-PCR test
- Hospital admission within 11 days from the onset of symptoms
- Spontaneous breathing with oxygen requirement ≥1 L/min
- Expected discharge > 96 hours at randomization
Who cannot join
- Pregnancy
- Presence of a tracheostomy
- Assistance by any non-invasive CPAP or NIV at the screening
- Treatment with high flow nasal cannula at the screening
- Clinical contraindication to the use of NO
- Patients enrolled in another interventional trial
Show all 15Show fewer
- Hospitalized and confirmed diagnosis of COVID-19 for more than 7 days
- Previous intubation for COVID-19
- Subject not committed to full support (DNR, DNI or CMO)
- Subject requiring oxygen at home for lung comorbidities
- The primary cause of hospitalization not due to COVID-19
- Subject receiving vasopressor at the time of screening
- History of malignancy or other irreversible disease/conditions with 6-month mortality >50%
- Oxygen saturation of 100% at screening, despite oxygen requirement
- Patients on dialysis at the time of enrollment
Trial locations and contacts
1 site in 1 country.
Russia1 site
Cardiology Research Institute, Tomsk National Research Medical Center, Russian Academy of Sciences
Tomsk, Russia, 634012
About this study
Official title: A Safety Study on the Use of Intermittent Versus Continuous Inhalation of NO in Spontaneous Breathing COVID-19 Patients
Preliminary data support the effect of Nitric Oxide (NO) on improving the oxygenation in mechanically ventilated patients and spontaneously breathing patients with COVID-19. In vitro studies showed an antiviral effect of NO against SARS-coronavirus. The optimal therapeutic regimen of NO gas in spontaneously breathing hypoxemic patients with COVID-19 is not known. We hypothesize that high concentration inhaled NO with an adjunct of continuous low dose administration between the high concentration treatments can be safely administered in hypoxemic COVID-19 patients compared to the high dose treatment alone. Prolonged administration of NO gas may benefit the patients in terms of the severity of the clinical course and time to recovery. Together with a clinical effect on ventilation-perfusion matching, a prolonged regimen would allow also an increase in antiviral activity (dose and time-dependent).
Read the detailed description
Coronavirus disease 2019 (COVID-19) consists mainly of a respiratory infection that spans from a mild involvement of the upper respiratory tract to severe pneumonia leading to respiratory distress, shock, and death. Fever, cough, and dyspnea/tachypnea, together with myalgia and fatigue, have been identified as the most common presenting symptoms. Most of the patients remain in a state of mild upper respiratory tract disease for a relatively long period (a median of 8-10 days), after which a proportion of up to 25% may develop severe hypoxemia and ARDS with the necessity of mechanical ventilation. Deterioration with ICU admission (most likely in older patients with comorbidities) raises the incidence of mortality in a range that goes from 3.4 up to 61%. Moreover, ICU admission poses a significant strain in terms of healthcare resources. Thus, a treatment able to avoid the progression of the disease from the mild to the severe phases would have a substantial benefit both in terms of lives saved and hospital resources spared. However, at the time, only Remdesivir and Dexamethasone have shown some benefits in robust clinical trials.
Nitric Oxide gas is a therapy currently approved for the treatment of pulmonary hypertension in newborns and is also used as rescue therapy in patients with acute respiratory distress syndrome (ARDS). The clinical role of NO gas in COVID-19 patients could be of particular relevance since there is in-vitro evidence of NO antiviral activity specifically against SARS coronavirus. At the time of the SARS pandemic, a small rescue trial on intubated patients with SARS showed that NO was effective in improving the oxygenation, fasten the resolution of chest X-ray abnormalities, and improve the clinical outcomes. Moreover, in vitro studies demonstrated that the NO-donor compound S-nitroso-N-acetylpenicillamine was able to increase the survival rate of in vitro mammalian cells infected with SARS-CoV. SARS-CoV and SARS-CoV-2 share the same subgenus inside the family Coronaviridae. The literature seems to point towards an a-specific rather than pathogen-specific antimicrobial effect of NO. Thus, the role of exogenous inhaled NO as a viricidal agent during COVID-19 infection could be hypothesized.
Nitric Oxide at high concentration has been found to be microbicidal but still safe in spontaneously breathing subjects in a phase I trial. There are several trials testing the efficacy of NO therapy in improving the outcome of COVID-19 patients. So far, only a retrospective observational study showed that NO gas is useful in improving the oxygenation in spontaneously breathing patients. However, the optimal therapeutic regimens and the efficacy of NO gas in improving the oxygenation in hypoxemic COVID-19 patients haven't been tested.
- Conditions
- Hypoxemia, Pneumonia, Viral, Coronavirus Infection
- Being tested
- Nitric Oxide-Sessions, Nitric Oxide-Continuous and Sessions
- Keywords
- Nitric Oxide gas, COVID-19, Hypoxemia, Viral Pneumonia
- Medical subject headings
- Hypoxia, Pneumonia, Viral, 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-SessionsDrug
Also called Nitric Oxide inhalation at high concentration
Nitric Oxide will be delivered at 200 ppm in 2 daily sessions (morning, evening; 9-12 hours apart) for 14 days. Each session will last 30 minutes, for a total of 60 minutes/day for each patient. A tank of NO gas will be connected to the inspiratory limb of the circuit, and the flow will be adjusted to deliver a target concentration of 200 ppm NO. Commercially available tanks will be used to provide the gas. The desired mixture of air, oxygen (O2), and NO will be titrated with the respective flowmeter to reach a concentration of 200 ppm at the inspiratory limb with the desired Fraction of inspired oxygen (FiO2).
Nitric Oxide-Continuous and SessionsDrug
Also called Nitric Oxide inhalation at high concentration + low concentration
Nitric Oxide will be delivered at 200 ppm in 2 daily sessions (morning, evening; 9-12 hours apart) for 14 days. Each session will last 30 minutes, for a total of 60 minutes/day for each patient. A tank of NO gas will be connected to the inspiratory limb of the circuit, and the flow will be adjusted to deliver a target concentration of 200 ppm NO. Commercially available tanks will be used to provide the gas. The desired mixture of air, oxygen (O2), and NO will be titrated with the respective flowmeter to reach a concentration of 200 ppm at the inspiratory limb with the desired Fraction of inspired oxygen (FiO2).
The subjects assigned to the group "NO High Concentration + Continuous Low Concentration" will receive in adjunction a continuous dose of NO at 20 ppm.
| Study group | Role | What they receive |
|---|---|---|
| NO High Concentration | Active comparator | Nitric oxide will be delivered twice a day with a non-rebreathing system that allows a safe administration of Nitric Oxide gas at high concentrations limiting the amount of NO2 delivered to the patient. Receives: Drug: Nitric Oxide-Sessions |
| NO High Concentration + Continuous Low Concentration | Experimental | Nitric oxide will be delivered twice a day with a non-rebreathing system that allows a safe administration of Nitric Oxide gas at high concentrations limiting the amount of NO2 delivered to the patient.
This arm will receive in addition a continuous low flow of Nitric Oxide at 20 ppm among the high concentration treatments. Receives: Drug: Nitric Oxide-Continuous and Sessions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Methemoglobin level at 48 hours
The primary outcome will be evaluated with the difference in Methemoglobin levels between the groups at 48 hours after randomization.
Measured: 48 hours
Secondary outcomes (8)
Change in Methemoglobin level at 96 hours
The primary outcome will be evaluated with the difference in Methemoglobineamia between the groups at 96 hours after randomization.
Measured: 96 hours
Improvement in oxygenation between the groups at 48 hours or at discharge if before 48 hours
The secondary outcome, "Improve the oxygenation at 48 hours," will be evaluated with the measure of the difference in oxygenation among the groups at 48 hours. Oxygenation will be measured in terms of the SpO2/FiO2 ratio.
Measured: 48 hours
Improvement in oxygenation between the groups at 96 hours or at discharge if before 96 hours
The secondary outcome, "Improve the oxygenation at 96 hours," will be evaluated with the measure of the difference in oxygenation between the groups at 96 hours. Oxygenation will be measured in terms of the SpO2/FiO2 ratio.
Measured: 96 hours
Rate of positive RT-PCR for SARS-CoV-2 between groups in 5 days, discharge, and 28 days
The secondary outcome "difference in the rate of negative RT-PCR for SARS CoV-2" will be evaluated as the rate of negativization of the RT-PCR for SARS-CoV-2 at 5 days after randomization, at discharge and at 28 days after randomization.
Measured: 28 days
Time to clinical recovery among groups, defined as time to interruption of oxygen administration for 24 hours or discharge
The secondary outcome "different time to clinical recovery" will be evaluated as the time between the randomization and the clinical indication to interrupt the administration of oxygen for 24 hours.
Measured: 28 days
Reduction in the inflammatory markers among groups
The secondary outcome "Different reduction in inflammatory markers" will be evaluated as improvement in the inflammatory markers (IL-6; Ferritin; White Blood Cells; Leucocyte count; CRP; D-Dimer) observed in blood samples collected at day 1, 2, 3, 4, and 7 compared to the Baseline value.
Measured: 7 days
Rate of Acute Kidney Disease (AKI) between groups during hospitalization
The secondary outcome "rate of AKI between groups" will be evaluated as the presence of a comparable rate of AKI during the hospital stay. The AKI will be defined according to the KDIGO classification.
Measured: 28 days
Difference in Katz score between groups
The secondary outcome "Difference in Katz score between groups" will be evaluated as the difference in Katz Activities of Daily Living between Baseline and day 28. This questionnaire will coincide with the 28-day phone call to assess health status and survival.
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2020
- Study start24 Jul 2020
- Primary completion17 Jul 2021
- Study completion17 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypoxemiaStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tomsk National Research Medical Center of the Russian Academy of Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Siberian State Medical University
- Responsible party
- Principal investigator, Nikolay Kamenshchikov, Tomsk National Research Medical Center of the Russian Academy of Sciences
- Investigators
- Nikolay O Kamenshchikov, M.D., Principal investigator, Cardiology Research Institute, Tomsk National Research Medical Center, Russian Academy of Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04476992
- Sponsor's protocol ID
- CRI-8322/1
- Acronym
- NICOR
- Status last verified
- Oct 2026
- First submitted
- 16 Jul 2020
- Last updated
- 21 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kamenshchikov NO, Safaee Fakhr B, Kravchenko IV, Dish AY, Podoksenov YK, Kozlov BN, Kalashnikova TP, Tyo MA, Anfinogenova ND, Boshchenko AA, Berra L. Assessment of continuous low-dose and high-dose burst of inhaled nitric oxide in spontaneously breathing COVID-19 patients: A randomized controlled trial. Nitric Oxide. 2024 Aug 1;149:41-48. doi: 10.1016/j.niox.2024.06.003. Epub 2024 Jun 14.
PubMed 38880198
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Safety Study on the Use of Intermittent Versus Continuous Inhalation of NO in Spontaneous Breathing COVID-19 Patients
- ClinicalTrials.gov ID
- NCT04476992
- Acronym / sponsor ID
- NICOR / CRI-8322/1
- Conditions
- Hypoxemia, Pneumonia, Viral, Coronavirus Infection
- Keywords
- Nitric Oxide gas, COVID-19, Hypoxemia, Viral Pneumonia
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Tomsk National Research Medical Center of the Russian Academy of SciencesUniversity, hospital or other
- Collaborators
- Siberian State Medical University
- Study start
- 24 Jul 2020 (actual)
- Primary completion
- 17 Jul 2021 (actual)
- Study completion
- 17 Sep 2021 (actual)
- First posted
- 20 Jul 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.
Preliminary data support the effect of Nitric Oxide (NO) on improving the oxygenation in mechanically ventilated patients and spontaneously breathing patients with COVID-19. In vitro studies showed an antiviral effect of NO against SARS-coronavirus. The optimal therapeutic regimen of NO gas in spontaneously breathing hypoxemic patients with COVID-19 is not known. We hypothesize that high concentration inhaled NO with an adjunct of continuous low dose administration between the high concentration treatments can be safely administered in hypoxemic COVID-19 patients compared to the high dose treatment alone. Prolonged administration of NO gas may benefit the patients in terms of the severity of the clinical course and time to recovery. Together with a clinical effect on ventilation-perfusion matching, a prolonged regimen would allow also an increase in antiviral activity (dose and time-dependent).
Detailed description
Coronavirus disease 2019 (COVID-19) consists mainly of a respiratory infection that spans from a mild involvement of the upper respiratory tract to severe pneumonia leading to respiratory distress, shock, and death. Fever, cough, and dyspnea/tachypnea, together with myalgia and fatigue, have been identified as the most common presenting symptoms. Most of the patients remain in a state of mild upper respiratory tract disease for a relatively long period (a median of 8-10 days), after which a proportion of up to 25% may develop severe hypoxemia and ARDS with the necessity of mechanical ventilation. Deterioration with ICU admission (most likely in older patients with comorbidities) raises the incidence of mortality in a range that goes from 3.4 up to 61%. Moreover, ICU admission poses a significant strain in terms of healthcare resources. Thus, a treatment able to avoid the progression of the disease from the mild to the severe phases would have a substantial benefit both in terms of lives saved and hospital resources spared. However, at the time, only Remdesivir and Dexamethasone have shown some benefits in robust clinical trials.
Nitric Oxide gas is a therapy currently approved for the treatment of pulmonary hypertension in newborns and is also used as rescue therapy in patients with acute respiratory distress syndrome (ARDS). The clinical role of NO gas in COVID-19 patients could be of particular relevance since there is in-vitro evidence of NO antiviral activity specifically against SARS coronavirus. At the time of the SARS pandemic, a small rescue trial on intubated patients with SARS showed that NO was effective in improving the oxygenation, fasten the resolution of chest X-ray abnormalities, and improve the clinical outcomes. Moreover, in vitro studies demonstrated that the NO-donor compound S-nitroso-N-acetylpenicillamine was able to increase the survival rate of in vitro mammalian cells infected with SARS-CoV. SARS-CoV and SARS-CoV-2 share the same subgenus inside the family Coronaviridae. The literature seems to point towards an a-specific rather than pathogen-specific antimicrobial effect of NO. Thus, the role of exogenous inhaled NO as a viricidal agent during COVID-19 infection could be hypothesized.
Nitric Oxide at high concentration has been found to be microbicidal but still safe in spontaneously breathing subjects in a phase I trial. There are several trials testing the efficacy of NO therapy in improving the outcome of COVID-19 patients. So far, only a retrospective observational study showed that NO gas is useful in improving the oxygenation in spontaneously breathing patients. However, the optimal therapeutic regimens and the efficacy of NO gas in improving the oxygenation in hypoxemic COVID-19 patients haven't been tested.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NO High Concentration | Active comparator | Drug: Nitric Oxide-SessionsNitric oxide will be delivered twice a day with a non-rebreathing system that allows a safe administration of Nitric Oxide gas at high concentrations limiting the amount of NO2 delivered to the patient. |
| NO High Concentration + Continuous Low Concentration | Experimental | Drug: Nitric Oxide-Continuous and SessionsNitric oxide will be delivered twice a day with a non-rebreathing system that allows a safe administration of Nitric Oxide gas at high concentrations limiting the amount of NO2 delivered to the patient. This arm will receive in addition a continuous low flow of Nitric Oxide at 20 ppm among the high concentration treatments. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- COVID-19 confirmed by a positive RT-PCR test
- Hospital admission within 11 days from the onset of symptoms
- Spontaneous breathing with oxygen requirement ≥1 L/min
- Expected discharge > 96 hours at randomization
Key exclusion criteria (15 listed)
- Pregnancy
- Presence of a tracheostomy
- Assistance by any non-invasive CPAP or NIV at the screening
- Treatment with high flow nasal cannula at the screening
- Clinical contraindication to the use of NO
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-SessionsAlso: Nitric Oxide inhalation at high concentrationNitric Oxide will be delivered at 200 ppm in 2 daily sessions (morning, evening; 9-12 hours apart) for 14 days. Each session will last 30 minutes, for a total of 60 minutes/day for each patient. A tank of NO gas will be connected to the inspiratory limb of the circuit, and the flow will be adjusted to deliver a target concentration of 200 ppm NO. Commercially available tanks will be used to provide the gas. The desired mixture of air, oxygen (O2), and NO will be titrated with the respective flowmeter to reach a concentration of 200 ppm at the inspiratory limb with the desired Fraction of inspired oxygen (FiO2). | Drug | NO High Concentration |
| Nitric Oxide-Continuous and SessionsAlso: Nitric Oxide inhalation at high concentration + low concentrationNitric Oxide will be delivered at 200 ppm in 2 daily sessions (morning, evening; 9-12 hours apart) for 14 days. Each session will last 30 minutes, for a total of 60 minutes/day for each patient. A tank of NO gas will be connected to the inspiratory limb of the circuit, and the flow will be adjusted to deliver a target concentration of 200 ppm NO. Commercially available tanks will be used to provide the gas. The desired mixture of air, oxygen (O2), and NO will be titrated with the respective flowmeter to reach a concentration of 200 ppm at the inspiratory limb with the desired Fraction of inspired oxygen (FiO2). The subjects assigned to the group "NO High Concentration + Continuous Low Concentration" will receive in adjunction a continuous dose of NO at 20 ppm. | Drug | NO High Concentration + Continuous Low Concentration |
Primary outcome
Change in Methemoglobin level at 48 hours
Time frame: 48 hours
The primary outcome will be evaluated with the difference in Methemoglobin levels between the groups at 48 hours after randomization.
8 secondary outcomes
Change in Methemoglobin level at 96 hours
Time frame: 96 hours
Improvement in oxygenation between the groups at 48 hours or at discharge if before 48 hours
Time frame: 48 hours
Improvement in oxygenation between the groups at 96 hours or at discharge if before 96 hours
Time frame: 96 hours
Rate of positive RT-PCR for SARS-CoV-2 between groups in 5 days, discharge, and 28 days
Time frame: 28 days
Time to clinical recovery among groups, defined as time to interruption of oxygen administration for 24 hours or discharge
Time frame: 28 days
Reduction in the inflammatory markers among groups
Time frame: 7 days
Rate of Acute Kidney Disease (AKI) between groups during hospitalization
Time frame: 28 days
Difference in Katz score between groups
Time frame: 28 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 21 Oct 2026.
- Derived from this study: PubMed 38880198Kamenshchikov NO, Safaee Fakhr B, Kravchenko IV, Dish AY, Podoksenov YK, Kozlov BN, Kalashnikova TP, Tyo MA, Anfinogenova ND, Boshchenko AA, Berra L. Assessment of continuous low-dose and high-dose burst of inhaled nitric oxide in spontaneously breathing COVID-19 patients: A randomized controlled trial. Nitric Oxide. 2024 Aug 1;149:41-48. doi: 10.1016/j.niox.2024.06.003. Epub 2024 Jun 14.
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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.
Nikolay O Kamenshchikov, M.D. principal investigator
Cardiology Research Institute, Tomsk National Research Medical Center, Russian Academy of Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Nitric Oxide-Sessions and Nitric Oxide-Continuous and Sessions in people with Hypoxemia and Pneumonia, Viral, run by Tomsk National Research Medical Center of the Russian Academy of Sciences at 1 site in Russia.
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 15 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 21 Oct 2026. 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 Russia. 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 combined 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.
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 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?
Change in Methemoglobin level at 48 hours (time frame: 48 hours). 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 NCT04476992, which also lists 1 linked publication.
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 21 Oct 2026.