Clinical trial NCT04771624: Assessment of Executive Functions After Covid-19
Official title: May Covid-19 Impair Executive Functions? A Crossectional Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid19
Cognitive Impairment
Lead sponsor: Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
Sponsor class: OTHER
First posted: 2021-02-25
Enrollment: 128
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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

Primary outcomes:
measure: Neuropsychological test scores
timeFrame: Up to 90 days
Secondary outcomes:
measure: Severity of the disease
timeFrame: Up to 90 days
Other outcomes:
Locations:
city: Diyarbakır
country: Turkey
facility: Sağlık Bilimleri Üniversitesi Gazi Yaşargil Training and Research Hospital
Study officials:
affiliation: Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
name: Mehmet D Güleken, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.