Assessment of Executive Functions After Covid-19 | NCT04771624

Studies
Assessment of Executive Functions After Covid-19

NCT04771624

Sponsor

Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital

Status

Completed

Last Update Posted

Nov 9, 2021Actual

Enrollment

128Actual

Phase

Not provided

Conditions

Covid19
Cognitive Impairment

Interventions

Not provided

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 30, 2020Actual

Primary Completion Date

Apr 30, 2021Actual

Completion Date

Nov 1, 2021Actual

First Submitted Date

Feb 22, 2021

First Submission Date that Met QC Criteria

Feb 24, 2021

First Posted Date

Feb 25, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 2, 2021

Last Update Posted Date

Nov 9, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

128Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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
Healthy		Subjects who do not have any general medical, neurological or psychiatric disorder

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Neuropsychological test scores	Neuropsychological test scores of Covid-19 patients in comparison with healthy control subjects	Up to 90 days

Secondary Outcomes

Measure	Description	Time Frame
Severity of the disease	Neuropsychological test score changes according to the disease severity of Covid-19 patients	Up to 90 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Mehmet D Güleken, MD	Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sağlık Bilimleri Üniversitesi Gazi Yaşargil Training and Research Hospital		Diyarbakır		21070	Turkey (Türkiye)

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
32869697	Background	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.
32912598	Background	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.

ID	Term
D000086382	COVID-19
D060825	Cognitive Dysfunction

ID	Term
D011024	Pneumonia, Viral
D011014	Pneumonia
D012141	Respiratory Tract Infections
D007239	Infections