- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04771624
Assessment of Executive Functions After Covid-19
November 2, 2021 updated by: Mehmet Diyaddin Güleken, Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
May Covid-19 Impair Executive Functions? A Crossectional Study
As it is evident that Covid-19 may have some impacts on cognition, the primary aim of this study is to investigate -if any- deficits of attention, working memory and executive functions after Covid-19.
Study Overview
Status
Completed
Conditions
Detailed Description
Since Covid-19 (Coronavirus Disease-2019) was declared as a pandemic by the World Health Organization (WHO) on December 31, 2019, it is still widespread and deadly.
As an ongoing pandemic, it has led to a panic and then a controlled fear in societies.
In many studies, neuropsychological deficits were observed in Covid-19 patients both during the illness and after recovery.
A recent study found that impairment in cognitive functions continued after recovery of Covid-19, and it was associated with peripherical inflammatory markers, such as C-Reactive Protein (CRP).
CRP, as a peripherical inflammatory marker, has been proven to be inversely related to serum levels of the brain-derived neurotrophic factor (BDNF), an important neurotrophin in the growth and differentiation of neurons.
In this study, attention, working memory and executive functions of Covid-19 patients at post-covid period and its relation with the severity of the disease will be investigated.
Study Type
Observational
Enrollment (Actual)
128
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Diyarbakır, Turkey, 21070
- Sağlık Bilimleri Üniversitesi Gazi Yaşargil Training and Research Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
In this study, 50 healthcare personnel diagnosed as Covid-19 by RT-PCR treated at the Department of Infectious Diseases, Gazi Yaşargil Tranining and Research Hospital, Sağlık Bilimleri Üniversitesi, Diyarbakır, have been randomly recorded and followed up for 60 days, and age, sex, education level and professionally matched 50 healthy subjects randomly recruited from the personnel of the same hospital.
Description
Inclusion Criteria:
Covid-19 patients:
- Diagnosed as Covid-19 by RT-PCR at least 60 days but not more than 90 days ago
- Asymptomatic at the moment
- Not having any other general medical, neurological or psychiatric conditions except Covid-19 at the time of acute infection
Healthy subjects:
- Not having any of Covid-19 symptoms at the testing time point
- Not having any general medical, neurological or psychiatric condition
Exclusion Criteria:
Covid-19 patients:
- Diagnosed as Covid-19 by RT-PCR less than 60 days or more than 90 days ago
- Having any symptom of acute phase of Covid-19
- Having any other general medical, neurlogical or psychiatric contidions
Healthy subjects:
- Having any of Covid-19 symptoms at the testing time point
- Having any general medical, neurological or psychiatric condition
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
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Patients
Subjects who have been Covid positive by RT-PCR at least 60 days ago and not having any symptoms of Covid-19 at the moment
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Healthy
Subjects who do not have any general medical, neurological or psychiatric disorder
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Neuropsychological test scores
Time Frame: Up to 90 days
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Neuropsychological test scores of Covid-19 patients in comparison with healthy control subjects
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Up to 90 days
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Severity of the disease
Time Frame: Up to 90 days
|
Neuropsychological test score changes according to the disease severity of Covid-19 patients
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Up to 90 days
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Mehmet D Güleken, MD, Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Wilson BA, Betteridge S, Fish J. Neuropsychological consequences of Covid-19. Neuropsychol Rehabil. 2020 Oct;30(9):1625-1628. doi: 10.1080/09602011.2020.1808483. No abstract available.
- Zhou H, Lu S, Chen J, Wei N, Wang D, Lyu H, Shi C, Hu S. The landscape of cognitive function in recovered COVID-19 patients. J Psychiatr Res. 2020 Oct;129:98-102. doi: 10.1016/j.jpsychires.2020.06.022. Epub 2020 Jun 30.
- Guo Q, Zheng Y, Shi J, Wang J, Li G, Li C, Fromson JA, Xu Y, Liu X, Xu H, Zhang T, Lu Y, Chen X, Hu H, Tang Y, Yang S, Zhou H, Wang X, Chen H, Wang Z, Yang Z. Immediate psychological distress in quarantined patients with COVID-19 and its association with peripheral inflammation: A mixed-method study. Brain Behav Immun. 2020 Aug;88:17-27. doi: 10.1016/j.bbi.2020.05.038. Epub 2020 May 19.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 30, 2020
Primary Completion (Actual)
April 30, 2021
Study Completion (Actual)
November 1, 2021
Study Registration Dates
First Submitted
February 22, 2021
First Submitted That Met QC Criteria
February 24, 2021
First Posted (Actual)
February 25, 2021
Study Record Updates
Last Update Posted (Actual)
November 9, 2021
Last Update Submitted That Met QC Criteria
November 2, 2021
Last Verified
November 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 21022021
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
All the data of the participants is being declared as it will be preserved, in the informed consent at the point of enrollment
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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