Long COVIDNCT06614309
Non-invasive Treatment for Long COVID (Post COVID-19 Condition) Brain Fog
A study testing Acute Progressive Carbon Dioxide, Acute Intermittent Hypoxia and Training: Progressive Carbon Dioxide Ramping in people with Long COVID, run by Mayo Clinic at 1 site in United States.
Trial summary
This study aims to assess the effects of both acute and chronic exposures to hypoxia and hypercapnia in patients with Long COVID syndrome. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Long COVID
- What is being tested?
- Acute Progressive Carbon Dioxide, Acute Intermittent Hypoxia and Training: Progressive Carbon Dioxide Ramping
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Sep 2024to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- English speaking
- Diagnosis of Long COVID
Who cannot join
- Any history of:
- Coronary artery dissection or aortic dissection
- Neurological disease (e.g. dementia, Alzheimer's disease, or other brain-related disease)
- Cerebrovascular disease or stroke
- Aneurysm
- If currently has:
Show all 25Show fewer
- Moderate-severe chronic obstructive pulmonary disease
- Uncontrolled moderate-severe asthma
- Moderate-severe bronchiectasis
- Moderate-severe interstitial lung disease, requiring the use of supplemental oxygen
- A necessity to use supplemental oxygen, for any reason
- New or worsening symptoms (decompensation) of heart failure
- Right heart disease due to chronic pulmonary disease/sleep apnea
- Uncontrolled myocardial ischemia or angina
- Uncontrolled heart arrhythmias
- Heart or lung infection (e.g. myocarditis or pericarditis)
- Left main coronary artery stenosis
- Moderate-severe aortic stenosis
- Pulmonary embolism, pulmonary infarction, or other blood clots
- Severe respiratory disease
- Chronic kidney disease
- Chronic liver disease
- Females of childbearing potential will complete a urine pregnancy test at their baseline visit to rule out pregnancy
- BMI >40
- Study staff unable to obtain adequate signal for cerebral blood flow
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Mayo Clinic in Arizona
Scottsdale, Arizona, 85259
Jordan Parks, 480-301-6616, parks.jordan@mayo.edu
Courtney M Wheatley-Guy, PhD
About this study
Official title: Pilot Study to Investigate Possible Non-invasive Treatment for Long COVID (Post COVID-19 Condition) Brain Fog
This study aims to assess the effects of both acute and chronic exposures to hypoxia and hypercapnia in patients with Long COVID syndrome.
- Conditions
- Long COVID
- Being tested
- Acute Placebo Visit, Acute Progressive Carbon Dioxide, Acute Intermittent Hypoxia, Training: Progressive Carbon Dioxide Ramping, Training: Intermittent Hypoxic Exposure
- Keywords
- brain fog, brain blood flow, heart rate variability, fatigue
- Medical subject headings
- Post-Acute COVID-19 Syndrome, Mental Fatigue, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acute Placebo VisitOther
The placebo visit will include 6 simulated cycles of 5 minutes breathing 21% oxygen from a douglas bag and 5 minutes breathing room air.
Acute Progressive Carbon DioxideOther
The progressive carbon dioxide visit will include a 60-minute progressive ramp which includes 6 cycles of progressive CO2 ramping starting at 0% and progressing up to 10% within 5 minutes immediately followed with 5 minutes of room air breathing in between cycles.
Acute Intermittent HypoxiaOther
The intermittent hypoxia exposure visit will include 6 cycles breathing 8-12% oxygen (O2) for 5 minutes with a target pulse oximeter saturation of 86-90%, followed by 5 minutes of breathing room air.
Training: Progressive Carbon Dioxide RampingOther
Intervention will consist of 6 to 10 study visits (3-5 sessions/week) to be completed within 14 days. Subjects will will be given the progressive CO2 ramp protocol of 60-minute sessions, which will include 6 cycles of progressive CO2 ramping starting at 0% and progressing up to 10% within 5 minutes immediately followed with 5 minutes of room air breathing in between cycles, for every visit during the 14 days.
Training: Intermittent Hypoxic ExposureOther
Intervention will consist of 6 to 10 study visits (3-5 sessions/week) to be completed within 14 days. Subjects will will be given the intermittent hypoxia exposure protocol of 60-minute sessions, which will include 6 cycles breathing 8-12% oxygen (O2) for 5 minutes with a target pulse oximeter saturation of 86-90%, followed by 5 minutes of breathing room air for every visit during the 14 days.
Training: Placebo ControlOther
Intervention will consist of 6 to 10 study visits (3-5 sessions/week) to be completed within 14 days. Subjects will complete 6 simulated cycles of 5 minutes breathing 21% oxygen from a douglas bag and 5 minutes breathing room air (60 minutes) for every visit during the 14 days.
| Study group | Role | What they receive |
|---|---|---|
| Acute exposure: Placebo, Progressive Carbon Dioxide, Intermittent Hypoxia | Experimental | Study group will receive the three interventions in this order: Placebo, Progressive Carbon Dioxide, then Intermittent Hypoxia Receives: Other: Acute Placebo Visit; Other: Acute Progressive Carbon Dioxide; Other: Acute Intermittent Hypoxia |
| Acute exposure: Placebo, Intermittent Hypoxia, Progressive Carbon Dioxide | Experimental | Study group will receive the three interventions in this order: Placebo, Intermittent Hypoxia, Progressive Carbon Dioxide Receives: Other: Acute Placebo Visit; Other: Acute Progressive Carbon Dioxide; Other: Acute Intermittent Hypoxia |
| Acute exposure: Intermittent Hypoxia, Placebo, Progressive Carbon Dioxide | Experimental | Study group will receive the three interventions in this order: Intermittent Hypoxia, Placebo, Progressive Carbon Dioxide Receives: Other: Acute Placebo Visit; Other: Acute Progressive Carbon Dioxide; Other: Acute Intermittent Hypoxia |
| Acute exposure: Intermittent Hypoxia, Progressive Carbon Dioxide, Placebo | Experimental | Study group will receive the three interventions in this order: Intermittent Hypoxia, Progressive Carbon Dioxide, Placebo Receives: Other: Acute Placebo Visit; Other: Acute Progressive Carbon Dioxide; Other: Acute Intermittent Hypoxia |
| Acute exposure: Progressive Carbon Dioxide, Placebo, Intermittent Hypoxia | Experimental | Study group will receive the three interventions in this order: Progressive Carbon Dioxide, Placebo, Intermittent Hypoxia Receives: Other: Acute Placebo Visit; Other: Acute Progressive Carbon Dioxide; Other: Acute Intermittent Hypoxia |
| Acute exposure: Progressive Carbon Dioxide, Intermittent Hypoxia, Placebo | Experimental | Study group will receive the three interventions in this order: Progressive Carbon Dioxide, Intermittent Hypoxia, Placebo Receives: Other: Acute Placebo Visit; Other: Acute Progressive Carbon Dioxide; Other: Acute Intermittent Hypoxia |
| Placebo Group | Placebo comparator | Study group will complete 6 simulated cycles of 5 minutes breathing 21% oxygen from a douglas bag and 5 minutes breathing room air (60 minutes) for every visit during the 14 days intervention period. Subjects will then return within 7 days of their final training visit to repeat baseline testing Receives: Other: Training: Placebo Control |
| Training Group | Experimental | Training Study group will be complete 6 cycles of either progressive CO2 ramp protocol or the intermittent hypoxia protocol for 60 minutes for every visit during the 14 days. Subjects will then return within 7 days of their final training visit to repeat baseline testing Receives: Other: Training: Progressive Carbon Dioxide Ramping; Other: Training: Intermittent Hypoxic Exposure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in cerebral blood flow
The intracranial middle cerebral arteries will be obtained (MCAv) will be imaged with a linear probe and duplex ultrasound system to simultaneously measure CBFv by pulse wave doppler (peak and mean flow)
Measured: Baseline, post-acute exposure and 14 days post training
Change in heart rate variability
Short- term HRV analysis of a 3-lead ECG recording (5 minute recording) will evaluate both time-domain parameters (mean heart rate, standard deviation of normal-to-normal (NN) intervals (SDNN) and root mean square of successive differences between NN intervals rMSSD) and frequency-domain parameters (total power, high frequency (HF) and low frequency (LF) and LF/HF ratio).
Measured: Baseline, post-acute exposure and 14 days post training
Change in brain fog scale
Questionnaire assessing of how much brain fog is affecting daily abilities
Measured: Baseline, post-acute exposure and 14 days post training
Secondary outcomes (6)
Change in fatigue functional assessment of chronic illness therapy-fatigue scale
Fatigue functional assessment of chronic illness therapy-fatigue scale (FACIT-Fatigue): assessment of how much fatigue is affecting daily abilities. Scores range from 0-52 for the FACIT with a higher score indicating higher levels of fatigue experienced.
Measured: Baseline, post-acute exposure and 14 days post training
Change in short form health survey (SF-36)
The Short Form (SF-36) Health Survey is a 36-item, participant-reported survey that measures patient health and disability. Possible scores range from 0 to 100, with 0 indicating maximum disability, and 100 indicating no disability.
Measured: Baseline, post-acute exposure and 14 days post training
Change in Trail making test
Trail making test: Consists of two parts. For part one, the subject will be presented with 25 numbered dots. The goal is to connect all 25 dots in numerical order quickly and accurately. The second part consists of 25 dots on the screen labelled with numbers and letters. The subject will then click the dots in sequential order by number followed by letter. For example, 1-A-2-B-3-C…, in the shortest amount of time possible while maintaining accuracy.
Measured: Baseline, post-acute exposure and 14 days post training
Change in rapid cognitive assessment tool (RCAT) score
The premise is to click spawning targets quickly and accurately. The assessment lasts one minute during which the game will add or reduce intensity based on real time performance. It is used to interpret psychological and psychomotor functions including hand-eye coordination, speed, response time, spatial awareness, situational awareness, and decision-making. Test takes one minute and score is calculate based on number of correct clicks.
Measured: Baseline, post-acute exposure and 14 days post training
Change in Task switching test performance
Task switching test will evaluate the individual's ability to switch between different tasks or operations. Participants are presented with a number between 1 and 9. The number will appear in one of two colors: purple or yellow. If the number is purple, the participant will answer with yes or no if the number is even. If yellow, the participants will answer with yes or no if the number is less than 5. Participants will see 40 numbers and their performance will be scored based on response time and accuracy.
Measured: Baseline, post-acute exposure and 14 days post training
Change in Rey Auditory Verbal Learning Test (AVLT) recall
Rey Auditory Verbal Learning Test (AVLT) will assess short term auditory recall. Subjects are read a list of 15 words and asked to repeat as many words as possible that they can remember back to the test administrator. They repeat this 5 times, then read a new list of 15 words to repeat back one time before returning to recall the first list of words.
Measured: Baseline, post-acute exposure and 14 days post training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2024
- Study start24 Sep 2024
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Long COVIDStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Courtney M. Wheatley, Mayo Clinic
- Investigators
- Courtney Wheatley-Guy, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06614309
- Sponsor's protocol ID
- 24-006115
- Status last verified
- Jun 2026
- First submitted
- 24 Sep 2024
- Last updated
- 5 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study to Investigate Possible Non-invasive Treatment for Long COVID (Post COVID-19 Condition) Brain Fog
- ClinicalTrials.gov ID
- NCT06614309
- Acronym / sponsor ID
- 24-006115
- Conditions
- Long COVID
- Keywords
- brain fog, brain blood flow, heart rate variability, fatigue
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 24 Sep 2024 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 26 Sep 2024 (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.
This study aims to assess the effects of both acute and chronic exposures to hypoxia and hypercapnia in patients with Long COVID syndrome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Acute exposure: Placebo, Progressive Carbon Dioxide, Intermittent Hypoxia | Experimental | Other: Acute Placebo Visit, Other: Acute Progressive Carbon Dioxide, Other: Acute Intermittent HypoxiaStudy group will receive the three interventions in this order: Placebo, Progressive Carbon Dioxide, then Intermittent Hypoxia |
| Acute exposure: Placebo, Intermittent Hypoxia, Progressive Carbon Dioxide | Experimental | Other: Acute Placebo Visit, Other: Acute Progressive Carbon Dioxide, Other: Acute Intermittent HypoxiaStudy group will receive the three interventions in this order: Placebo, Intermittent Hypoxia, Progressive Carbon Dioxide |
| Acute exposure: Intermittent Hypoxia, Placebo, Progressive Carbon Dioxide | Experimental | Other: Acute Placebo Visit, Other: Acute Progressive Carbon Dioxide, Other: Acute Intermittent HypoxiaStudy group will receive the three interventions in this order: Intermittent Hypoxia, Placebo, Progressive Carbon Dioxide |
| Acute exposure: Intermittent Hypoxia, Progressive Carbon Dioxide, Placebo | Experimental | Other: Acute Placebo Visit, Other: Acute Progressive Carbon Dioxide, Other: Acute Intermittent HypoxiaStudy group will receive the three interventions in this order: Intermittent Hypoxia, Progressive Carbon Dioxide, Placebo |
| Acute exposure: Progressive Carbon Dioxide, Placebo, Intermittent Hypoxia | Experimental | Other: Acute Placebo Visit, Other: Acute Progressive Carbon Dioxide, Other: Acute Intermittent HypoxiaStudy group will receive the three interventions in this order: Progressive Carbon Dioxide, Placebo, Intermittent Hypoxia |
| Acute exposure: Progressive Carbon Dioxide, Intermittent Hypoxia, Placebo | Experimental | Other: Acute Placebo Visit, Other: Acute Progressive Carbon Dioxide, Other: Acute Intermittent HypoxiaStudy group will receive the three interventions in this order: Progressive Carbon Dioxide, Intermittent Hypoxia, Placebo |
| Placebo Group | Placebo comparator | Other: Training: Placebo ControlStudy group will complete 6 simulated cycles of 5 minutes breathing 21% oxygen from a douglas bag and 5 minutes breathing room air (60 minutes) for every visit during the 14 days intervention period. Subjects will then return within 7 days of their final training visit to repeat baseline testing |
| Training Group | Experimental | Other: Training: Progressive Carbon Dioxide Ramping, Other: Training: Intermittent Hypoxic ExposureTraining Study group will be complete 6 cycles of either progressive CO2 ramp protocol or the intermittent hypoxia protocol for 60 minutes for every visit during the 14 days. Subjects will then return within 7 days of their final training visit to repeat baseline testing |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- English speaking
- Diagnosis of Long COVID
Key exclusion criteria (25 listed)
- Any history of:
- If currently has:
- Females of childbearing potential will complete a urine pregnancy test at their baseline visit to rule out pregnancy
- BMI >40
- Study staff unable to obtain adequate signal for cerebral blood flow
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 |
|---|---|---|
| Acute Placebo VisitThe placebo visit will include 6 simulated cycles of 5 minutes breathing 21% oxygen from a douglas bag and 5 minutes breathing room air. | Other | Acute exposure: Intermittent Hypoxia, Placebo, Progressive Carbon Dioxide, Acute exposure: Intermittent Hypoxia, Progressive Carbon Dioxide, Placebo, Acute exposure: Placebo, Intermittent Hypoxia, Progressive Carbon Dioxide, Acute exposure: Placebo, Progressive Carbon Dioxide, Intermittent Hypoxia, Acute exposure: Progressive Carbon Dioxide, Intermittent Hypoxia, Placebo, Acute exposure: Progressive Carbon Dioxide, Placebo, Intermittent Hypoxia |
| Acute Progressive Carbon DioxideThe progressive carbon dioxide visit will include a 60-minute progressive ramp which includes 6 cycles of progressive CO2 ramping starting at 0% and progressing up to 10% within 5 minutes immediately followed with 5 minutes of room air breathing in between cycles. | Other | Acute exposure: Intermittent Hypoxia, Placebo, Progressive Carbon Dioxide, Acute exposure: Intermittent Hypoxia, Progressive Carbon Dioxide, Placebo, Acute exposure: Placebo, Intermittent Hypoxia, Progressive Carbon Dioxide, Acute exposure: Placebo, Progressive Carbon Dioxide, Intermittent Hypoxia, Acute exposure: Progressive Carbon Dioxide, Intermittent Hypoxia, Placebo, Acute exposure: Progressive Carbon Dioxide, Placebo, Intermittent Hypoxia |
| Acute Intermittent HypoxiaThe intermittent hypoxia exposure visit will include 6 cycles breathing 8-12% oxygen (O2) for 5 minutes with a target pulse oximeter saturation of 86-90%, followed by 5 minutes of breathing room air. | Other | Acute exposure: Intermittent Hypoxia, Placebo, Progressive Carbon Dioxide, Acute exposure: Intermittent Hypoxia, Progressive Carbon Dioxide, Placebo, Acute exposure: Placebo, Intermittent Hypoxia, Progressive Carbon Dioxide, Acute exposure: Placebo, Progressive Carbon Dioxide, Intermittent Hypoxia, Acute exposure: Progressive Carbon Dioxide, Intermittent Hypoxia, Placebo, Acute exposure: Progressive Carbon Dioxide, Placebo, Intermittent Hypoxia |
| Training: Progressive Carbon Dioxide RampingIntervention will consist of 6 to 10 study visits (3-5 sessions/week) to be completed within 14 days. Subjects will will be given the progressive CO2 ramp protocol of 60-minute sessions, which will include 6 cycles of progressive CO2 ramping starting at 0% and progressing up to 10% within 5 minutes immediately followed with 5 minutes of room air breathing in between cycles, for every visit during the 14 days. | Other | Training Group |
| Training: Intermittent Hypoxic ExposureIntervention will consist of 6 to 10 study visits (3-5 sessions/week) to be completed within 14 days. Subjects will will be given the intermittent hypoxia exposure protocol of 60-minute sessions, which will include 6 cycles breathing 8-12% oxygen (O2) for 5 minutes with a target pulse oximeter saturation of 86-90%, followed by 5 minutes of breathing room air for every visit during the 14 days. | Other | Training Group |
| Training: Placebo ControlIntervention will consist of 6 to 10 study visits (3-5 sessions/week) to be completed within 14 days. Subjects will complete 6 simulated cycles of 5 minutes breathing 21% oxygen from a douglas bag and 5 minutes breathing room air (60 minutes) for every visit during the 14 days. | Other | Placebo Group |
Primary outcome
Change in cerebral blood flow
Time frame: Baseline, post-acute exposure and 14 days post training
The intracranial middle cerebral arteries will be obtained (MCAv) will be imaged with a linear probe and duplex ultrasound system to simultaneously measure CBFv by pulse wave doppler (peak and mean flow)
Change in heart rate variability
Time frame: Baseline, post-acute exposure and 14 days post training
Short- term HRV analysis of a 3-lead ECG recording (5 minute recording) will evaluate both time-domain parameters (mean heart rate, standard deviation of normal-to-normal (NN) intervals (SDNN) and root mean square of successive differences between NN intervals rMSSD) and frequency-domain parameters (total power, high frequency (HF) and low frequency (LF) and LF/HF ratio).
Change in brain fog scale
Time frame: Baseline, post-acute exposure and 14 days post training
Questionnaire assessing of how much brain fog is affecting daily abilities
6 secondary outcomes
Change in fatigue functional assessment of chronic illness therapy-fatigue scale
Time frame: Baseline, post-acute exposure and 14 days post training
Change in short form health survey (SF-36)
Time frame: Baseline, post-acute exposure and 14 days post training
Change in Trail making test
Time frame: Baseline, post-acute exposure and 14 days post training
Change in rapid cognitive assessment tool (RCAT) score
Time frame: Baseline, post-acute exposure and 14 days post training
Change in Task switching test performance
Time frame: Baseline, post-acute exposure and 14 days post training
Change in Rey Auditory Verbal Learning Test (AVLT) recall
Time frame: Baseline, post-acute exposure and 14 days post training
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2026.
- 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.
Courtney Wheatley-Guy principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acute Progressive Carbon Dioxide, Acute Intermittent Hypoxia and Training: Progressive Carbon Dioxide Ramping in people with Long COVID, run by Mayo Clinic at 1 site in United States.
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 2 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: looking for participants now, as of the sponsor's last update on 5 Jun 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 United States. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jordan Parks (480-301-6616, parks.jordan@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in cerebral blood flow (time frame: Baseline, post-acute exposure and 14 days post training). The study lists 3 primary outcomes in all. 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 5 Jun 2026.