Assessment of Clinical Effects of Coenzyme Q10 Levels in COVID-19 Patients in Intensive Care Unit

• Sponsor: Hacettepe University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05058716
• Collaborator: (none)
• Enrollment: 150
• Location: 1
• Anticipated Duration (Months): 23
• Patients Per Site Per Month: 6.5

Study Details

Study Description

Brief 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. 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.

Condition or Disease	Intervention/Treatment	Phase
COVID-19	Diagnostic Test: blood sample

Study Design

• Study Type: Observational
• Anticipated Enrollment: 150 participants
• Observational Model: Other
• Time Perspective: Prospective
• 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.
• Actual Study Start Date: Jan 1, 2021
• Anticipated Primary Completion Date: Oct 1, 2022
• Anticipated Study Completion Date: Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
COVID-19 positive patients	Diagnostic Test: blood sample; weekly blood sample - coenzym q10 levels
COVID-19 negative patients	Diagnostic Test: blood sample; weekly blood sample - coenzym q10 levels

Outcome Measures

Primary Outcome Measures

1. mortality [from the first day of hospitalization until the date of death from any cause]

   yes or no

2. duration of mechanical ventilation [from the first day of hospitalization and during ICU stay period]

   days

3. duration of vasopressor agent requirement [from the first day of hospitalization and during ICU stay period]

   days

Secondary Outcome Measures

1. any organ failure [from the first day of hospitalization until the date of death from any cause or discharge from ICU]

   yes or no

2. new thromboembolic event [from the first day of hospitalization until the date of death from any cause or discharge from ICU]

   yes or no

3. ICU stay period [from the first day of hospitalization until the date of death from any cause or discharge from ICU]

   days

4. hospital stay period [from the first day of discharge from ICU to ward until the date of death or discharge from the hospital]

   days

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

Exclusion Criteria:

• being under the age of 18

• being pregnant

• patient refusal

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hacettepe University Hospital	Ankara	Altındağ	Turkey	06230

Sponsors and Collaborators

• Hacettepe University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Merve Goknur Soysal Kaya, Research assistant, Hacettepe University
• ClinicalTrials.gov Identifier: NCT05058716
• Other Study ID Numbers: 19423
• First Posted: Sep 28, 2021
• Last Update Posted: Mar 17, 2022
• Last Verified: Mar 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: COVID-19

Study Results

No Results Posted as of Mar 17, 2022