COVID-19NCT05058716
Assessment of Clinical Effects of Coenzyme Q10 Levels in COVID-19 Patients in Intensive Care Unit
An observational study of COVID-19, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
The study will be done in Hacettepe University Anesthesiology and Reanimation Intensive Care Unit. The investigators will accept COVID-19 diagnosed or suspected patients to the ICU. 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?
- blood sample
- How many people
- 150 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2021to 1 Dec 2022
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Hacettepe University Anesthesiology and Reanimation Intensive Care Unit
Who may be able to join
- -
Who cannot join
- being under the age of 18
- being pregnant
- patient refusal
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Hacettepe University Hospital
Ankara, Altındağ, 06230
Merve Göknur Soysal Kaya, Research assisstant, 0905345533181, soysal_mervegoknur@hotmail.com
Seda Banu Akıncı, Professor, sedabanu@yahoo.com
About this study
Official title: Our Study Will be Carried Out in Hacettepe University Anesthesiology and Reanimation Intensive Care Unit. COVID-19 Positive or Suspected Patients Will be Admitted to the Unit. Coenzyme Q10 Levels Will be Checked in the First Day of Hospitalization and Once a Week. The Relationship Between Results and Clinical Course Will be Evaluated.
The study will be done in Hacettepe University Anesthesiology and Reanimation Intensive Care Unit. The investigators will accept COVID-19 diagnosed or suspected patients to the ICU. In the first day of hospitalization and after that once a week, the investigators will take blood samples from the patients to evaluate Coenzyme q10 levels. Our hypothesis is that there is a relationship between low coenzyme q10 levels and poor clinical outcome.
- Conditions
- COVID-19
- Being tested
- blood sample
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood sampleDiagnostic test
weekly blood sample - coenzym q10 levels
| Study group | Role | What they receive |
|---|---|---|
| COVID-19 positive patients | Not described Receives: Diagnostic Test: blood sample | |
| COVID-19 negative patients | Not described Receives: Diagnostic Test: blood sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
mortality
yes or no
Measured: from the first day of hospitalization until the date of death from any cause
duration of mechanical ventilation
days
Measured: from the first day of hospitalization and during ICU stay period
duration of vasopressor agent requirement
days
Measured: from the first day of hospitalization and during ICU stay period
Secondary outcomes (4)
any organ failure
yes or no
Measured: from the first day of hospitalization until the date of death from any cause or discharge from ICU
new thromboembolic event
yes or no
Measured: from the first day of hospitalization until the date of death from any cause or discharge from ICU
ICU stay period
days
Measured: from the first day of hospitalization until the date of death from any cause or discharge from ICU
hospital stay period
days
Measured: from the first day of discharge from ICU to ward until the date of death or discharge from the hospital
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2021
- Study start1 Jan 2021
- Primary completion1 Oct 2022 (estimated)
- Study completion1 Dec 2022 (estimated)
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 Hacettepe 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
- Other
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Merve Goknur Soysal Kaya, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05058716
- Sponsor's protocol ID
- 19423
- Status last verified
- Mar 2022
- First submitted
- 22 Sep 2021
- Last updated
- 17 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Our Study Will be Carried Out in Hacettepe University Anesthesiology and Reanimation Intensive Care Unit. COVID-19 Positive or Suspected Patients Will be Admitted to the Unit. Coenzyme Q10 Levels Will be Checked in the First Day of Hospitalization and Once a Week. The Relationship Between Results and Clinical Course Will be Evaluated.
- ClinicalTrials.gov ID
- NCT05058716
- Acronym / sponsor ID
- 19423
- Conditions
- COVID-19
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 Oct 2022 (estimated)
- Study completion
- 1 Dec 2022 (estimated)
- First posted
- 28 Sep 2021 (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.
The study will be done in Hacettepe University Anesthesiology and Reanimation Intensive Care Unit. The investigators will accept COVID-19 diagnosed or suspected patients to the ICU. In the first day of hospitalization and after that once a week, the investigators will take blood samples from the patients to evaluate Coenzyme q10 levels. Our hypothesis is that there is a relationship between low coenzyme q10 levels and poor clinical outcome.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| COVID-19 positive patients | – | Diagnostic Test: blood sample |
| COVID-19 negative patients | – | Diagnostic Test: blood sample |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Hacettepe University Anesthesiology and Reanimation Intensive Care Unit
Key inclusion criteria (1 listed)
- -
Key exclusion criteria (3 listed)
- being under the age of 18
- being pregnant
- patient refusal
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 |
|---|---|---|
| blood sampleweekly blood sample - coenzym q10 levels | Diagnostic test | COVID-19 negative patients, COVID-19 positive patients |
Primary outcome
mortality
Time frame: from the first day of hospitalization until the date of death from any cause
yes or no
duration of mechanical ventilation
Time frame: from the first day of hospitalization and during ICU stay period
days
duration of vasopressor agent requirement
Time frame: from the first day of hospitalization and during ICU stay period
days
4 secondary outcomes
any organ failure
Time frame: from the first day of hospitalization until the date of death from any cause or discharge from ICU
new thromboembolic event
Time frame: from the first day of hospitalization until the date of death from any cause or discharge from ICU
ICU stay period
Time frame: from the first day of hospitalization until the date of death from any cause or discharge from ICU
hospital stay period
Time frame: from the first day of discharge from ICU to ward until the date of death or discharge from the hospital
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 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.
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, run by Hacettepe University at 1 site in Turkey (Türkiye).
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: status not confirmed, as of the sponsor's last update on 17 Mar 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 Turkey (Türkiye). 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mortality (time frame: from the first day of hospitalization until the date of death from any cause). 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 17 Mar 2022.