NCT05058716

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2021

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

September 22, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 28, 2021

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

March 17, 2022

Status Verified

March 1, 2022

Enrollment Period

1.7 years

First QC Date

September 22, 2021

Last Update Submit

March 15, 2022

Conditions

Outcome Measures

Primary Outcomes (3)

  • mortality

    yes or no

    from the first day of hospitalization until the date of death from any cause

  • duration of mechanical ventilation

    days

    from the first day of hospitalization and during ICU stay period

  • duration of vasopressor agent requirement

    days

    from the first day of hospitalization and during ICU stay period

Secondary Outcomes (4)

  • any organ failure

    from the first day of hospitalization until the date of death from any cause or discharge from ICU

  • new thromboembolic event

    from the first day of hospitalization until the date of death from any cause or discharge from ICU

  • ICU stay period

    from the first day of hospitalization until the date of death from any cause or discharge from ICU

  • hospital stay period

    from the first day of discharge from ICU to ward until the date of death or discharge from the hospital

Study Arms (2)

COVID-19 positive patients

Diagnostic Test: blood sample

COVID-19 negative patients

Diagnostic Test: blood sample

Interventions

blood sampleDIAGNOSTIC_TEST

weekly blood sample - coenzym q10 levels

COVID-19 negative patientsCOVID-19 positive patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Hacettepe University Anesthesiology and Reanimation Intensive Care Unit

You may not qualify if:

  • being under the age of 18
  • being pregnant
  • patient refusal

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hacettepe University Hospital

Ankara, Altındağ, 06230, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

COVID-19

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research assistant

Study Record Dates

First Submitted

September 22, 2021

First Posted

September 28, 2021

Study Start

January 1, 2021

Primary Completion

October 1, 2022

Study Completion

December 1, 2022

Last Updated

March 17, 2022

Record last verified: 2022-03

Locations