COVID-19 Acute Respiratory Distress SyndromeNCT05798260
T-Cell Mitochondrial Respiration Response to Ketone Monoester Supplement in Healthy Volunteers and COVID-19
An observational study of COVID-19 Acute Respiratory Distress Syndrome, run by Duke University at 1 site in United States.
Trial summary
T-Cell Mitochondrial Respiration Response to Ketone monoester (Ketoneaid) in Healthy Volunteers and COVID-19 Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- COVID-19 Acute Respiratory Distress Syndrome
- What is being tested?
- Agilent Seahorse XF Cell Mito Stress Test
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jun 2024to 31 Oct 2024
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients admitted at Duke Hospital Medical and Surgical ICU with COVID-19 manifested with ARDS and on the ventilator
Who may be able to join
- COVID-19 with ARDS and on the ventilator
Who cannot join
- Pregnant
- <18 years
- Steroid use
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intensive Care Unit (ICU) Biospecimen and Data Repository
T-Cell Mitochondrial Respiration Response to Ketone monoester (Ketoneaid) in Healthy Volunteers and COVID-19
- Being tested
- Agilent Seahorse XF Cell Mito Stress Test
- Keywords
- mitochondria, ketone monoester, seahorse, ketoneaid, SRC, FCCP, ECAR
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Agilent Seahorse XF Cell Mito Stress TestDiagnostic test
Also called Ketoneaid (Ketone monoester)
The Agilent Seahorse XF Cell Mito Stress Test measures key parameters of mitochondrial function by directly measuring the oxygen consumption rate (OCR) of cells on the Seahorse XFe and XF Extracellular Flux Analyzers. It is a plate-based live cell assay that allows to monitor spare respiratory capacity (SRC), basal respiration, ATP production-coupled respiration, maximal respiration, and non-mitochondrial respiration in real time before and after ketone monoester
| Study group | Role | What they receive |
|---|---|---|
| Healthy Volunteers | Healthy Volunteers Receives: Diagnostic Test: Agilent Seahorse XF Cell Mito Stress Test | |
| COVID-19 positive admitted to the ICU and on the ventilator | COVID-19 positive admitted to the ICU and on the ventilator Receives: Diagnostic Test: Agilent Seahorse XF Cell Mito Stress Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Spare Respiratory Capacity (SRC)
This measurement indicates the capability of the cell to respond to an energetic demand as well as how closely the cell is to respiring to its theoretical maximum. The cell's ability to respond to demand can be an indicator of cell fitness or flexibility
Measured: through study completion, an average of 2 months
Basal Respiration
Oxygen consumption used to meet cellular ATP demand resulting from mitochondrial proton leak. Shows energetic demand of the cell under baseline conditions.
Measured: through study completion, an average of 2 months
ATP production-coupled Respiration
The decrease in oxygen consumption rate upon injection of the ATP synthase inhibitor oligomycin represents the portion of basal respiration that was being used to drive ATP production. Shows ATP produced by the mitochondria that contributes to meeting the energetic needs of the cell.
Measured: upon admission
Maximal Respiration
The maximal oxygen consumption rate attained by adding the uncoupler FCCP. FCCP mimics a physiological "energy demand" by stimulating the respiratory chain to operate at maximum capacity, which causes rapid oxidation of substrates (sugars, fats, and amino acids) to meet this metabolic challenge. Shows the maximum rate of respiration that the cell can achieve.
Measured: upon admission
Non-Mitochondrial Respiration
Oxygen consumption that persists due to a subset of cellular enzymes that continue to consume oxygen after the addition of rotenone and antimycin A. This is important to get an accurate measure of mitochondrial respiration.
Measured: through study completion, an average of 2 months
Secondary outcomes (2)
Oxygen Consumption Rate (OCR)
The oxygen consumption rate (OCR) of cells is an important indicator of normal cellular function. It is used as a parameter to study mitochondrial function as well as a marker of factors triggering the switch from healthy oxidative phosphorylation to aerobic glycolysis
Measured: through study completion, an average of 2 months
extracellular acidification rate (ECAR)
Measuring the extracellular acidification rate (ECAR) provides a method for detection of glycolytic flux in T-cells in response to ketone mono ester
Measured: through study completion, an average of 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2023
- Study start30 Jun 2024 (estimated)
- Primary completion31 Aug 2024 (estimated)
- Study completion31 Oct 2024 (estimated)
Why it stopped: Study Never Started
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19 Acute Respiratory Distress SyndromeStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christina Barkauskas, MD, Principal investigator, Research Director Duke Medical ICU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05798260
- Sponsor's protocol ID
- Pro00101196
- Status last verified
- May 2024
- First submitted
- 28 Mar 2023
- Last updated
- 3 Jun 2024
- 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 3 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intensive Care Unit (ICU) Biospecimen and Data Repository
- ClinicalTrials.gov ID
- NCT05798260
- Acronym / sponsor ID
- Pro00101196
- Keywords
- mitochondria, ketone monoester, seahorse, ketoneaid, SRC, FCCP, ECAR
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Study Never Started
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 30 Jun 2024 (estimated)
- Primary completion
- 31 Aug 2024 (estimated)
- Study completion
- 31 Oct 2024 (estimated)
- First posted
- 4 Apr 2023 (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.
T-Cell Mitochondrial Respiration Response to Ketone monoester (Ketoneaid) in Healthy Volunteers and COVID-19
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy Volunteers | – | Diagnostic Test: Agilent Seahorse XF Cell Mito Stress TestHealthy Volunteers |
| COVID-19 positive admitted to the ICU and on the ventilator | – | Diagnostic Test: Agilent Seahorse XF Cell Mito Stress TestCOVID-19 positive admitted to the ICU and on the ventilator |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted at Duke Hospital Medical and Surgical ICU with COVID-19 manifested with ARDS and on the ventilator
Key inclusion criteria (1 listed)
- COVID-19 with ARDS and on the ventilator
Key exclusion criteria (3 listed)
- Pregnant
- <18 years
- Steroid use
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 |
|---|---|---|
| Agilent Seahorse XF Cell Mito Stress TestAlso: Ketoneaid (Ketone monoester)The Agilent Seahorse XF Cell Mito Stress Test measures key parameters of mitochondrial function by directly measuring the oxygen consumption rate (OCR) of cells on the Seahorse XFe and XF Extracellular Flux Analyzers. It is a plate-based live cell assay that allows to monitor spare respiratory capacity (SRC), basal respiration, ATP production-coupled respiration, maximal respiration, and non-mitochondrial respiration in real time before and after ketone monoester | Diagnostic test | COVID-19 positive admitted to the ICU and on the ventilator, Healthy Volunteers |
Primary outcome
Spare Respiratory Capacity (SRC)
Time frame: through study completion, an average of 2 months
This measurement indicates the capability of the cell to respond to an energetic demand as well as how closely the cell is to respiring to its theoretical maximum. The cell's ability to respond to demand can be an indicator of cell fitness or flexibility
Basal Respiration
Time frame: through study completion, an average of 2 months
Oxygen consumption used to meet cellular ATP demand resulting from mitochondrial proton leak. Shows energetic demand of the cell under baseline conditions.
ATP production-coupled Respiration
Time frame: upon admission
The decrease in oxygen consumption rate upon injection of the ATP synthase inhibitor oligomycin represents the portion of basal respiration that was being used to drive ATP production. Shows ATP produced by the mitochondria that contributes to meeting the energetic needs of the cell.
Maximal Respiration
Time frame: upon admission
The maximal oxygen consumption rate attained by adding the uncoupler FCCP. FCCP mimics a physiological "energy demand" by stimulating the respiratory chain to operate at maximum capacity, which causes rapid oxidation of substrates (sugars, fats, and amino acids) to meet this metabolic challenge. Shows the maximum rate of respiration that the cell can achieve.
Non-Mitochondrial Respiration
Time frame: through study completion, an average of 2 months
Oxygen consumption that persists due to a subset of cellular enzymes that continue to consume oxygen after the addition of rotenone and antimycin A. This is important to get an accurate measure of mitochondrial respiration.
2 secondary outcomes
Oxygen Consumption Rate (OCR)
Time frame: through study completion, an average of 2 months
extracellular acidification rate (ECAR)
Time frame: through study completion, an average of 2 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2024.
- 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.
Christina Barkauskas, MD principal investigator
Research Director Duke Medical ICU
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19 Acute Respiratory Distress Syndrome, run by Duke University 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 1 inclusion and 3 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: withdrawn, as of the sponsor's last update on 3 Jun 2024. 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. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Spare Respiratory Capacity (SRC) (time frame: through study completion, an average of 2 months). The study lists 5 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 3 Jun 2024.