Covid19NCT04771624
Assessment of Executive Functions After Covid-19
An observational study of Covid19 and Cognitive Impairment, run by Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Covid19, Cognitive Impairment
- How many people
- 128 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Oct 2020to 1 Nov 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older 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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Sağlık Bilimleri Üniversitesi Gazi Yaşargil Training and Research Hospital
Diyarbakır, 21070
About this study
Official title: 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.
Read the 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.
- Conditions
- Covid19, Cognitive Impairment
- Medical subject headings
- COVID-19, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neuropsychological test scores
Neuropsychological test scores of Covid-19 patients in comparison with healthy control subjects
Measured: Up to 90 days
Secondary outcomes (1)
Severity of the disease
Neuropsychological test score changes according to the disease severity of Covid-19 patients
Measured: Up to 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2021
- Study start30 Oct 2020
- Primary completion30 Apr 2021
- Study completion1 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mehmet Diyaddin Güleken, Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
- Investigators
- Mehmet D Güleken, MD, Principal investigator, Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04771624
- Sponsor's protocol ID
- 21022021
- Status last verified
- Nov 2021
- First submitted
- 22 Feb 2021
- Last updated
- 9 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All the data of the participants is being declared as it will be preserved, in the informed consent at the point of enrollment
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.
PubMed 32869697Zhou 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.
PubMed 32912598Guo 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.
PubMed 32416290
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- May Covid-19 Impair Executive Functions? A Crossectional Study
- ClinicalTrials.gov ID
- NCT04771624
- Acronym / sponsor ID
- 21022021
- Conditions
- Covid19, Cognitive Impairment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Saglik Bilimleri Universitesi Gazi Yasargil Training and Research HospitalUniversity, hospital or other
- Study start
- 30 Oct 2020 (actual)
- Primary completion
- 30 Apr 2021 (actual)
- Study completion
- 1 Nov 2021 (actual)
- First posted
- 25 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older 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.
Key inclusion criteria (7 listed)
- 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
- Not having any of Covid-19 symptoms at the testing time point
- Not having any general medical, neurological or psychiatric condition
Key exclusion criteria (7 listed)
- 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
- Having any of Covid-19 symptoms at the testing time point
- Having any general medical, neurological or psychiatric condition
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Neuropsychological test scores
Time frame: Up to 90 days
Neuropsychological test scores of Covid-19 patients in comparison with healthy control subjects
1 secondary outcome
Severity of the disease
Time frame: Up to 90 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2021.
- Background: PubMed 32869697Wilson 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.
- Background: PubMed 32912598Zhou 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.
- Background: PubMed 32416290Guo 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.
- Individual participant dataSharing planned: No. All the data of the participants is being declared as it will be preserved, in the informed consent at the point of enrollment
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mehmet D Güleken, MD principal investigator
Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19 and Cognitive Impairment, run by Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neuropsychological test scores (time frame: Up to 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04771624, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2021.