COVID-19 Acute Respiratory Distress SyndromeNCT04978246
Cognitive Functions After COVID-19
An observational study of COVID-19 Acute Respiratory Distress Syndrome and Cognitive Decline, run by Medipol University at 1 site in Turkey (Türkiye).
Trial summary
This study was aimed to evaluate the post-infection cognitive functions of adult individuals with COVID-19. 50 individuals with COVID-19 and 50 healthy control groups were included in the study. Cognitive functions of individuals with COVID19 compared with healthy individuals. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- COVID-19 Acute Respiratory Distress Syndrome, Cognitive Decline
- What is being tested?
- Neuropsychometric Test
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Dec 2020to 30 Jul 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 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Community sample
Who may be able to join
- Having positive for the COVID-19 RT-PCR test and turned negative in the last 60 days.
- be 18-50 years old
- 21 days have passed since the onset of the disease
Who cannot join
- Having any neurological or psychiatric illness
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Medipol University
Beykoz, Istanbul, 34810
About this study
Official title: Evaluation Of Cognitive Functions In Adult Individuals With COVID-19
This study was aimed to evaluate the post-infection cognitive functions of adult individuals with COVID-19. 50 individuals with COVID-19 and 50 healthy control groups were included in the study. Cognitive functions of individuals with COVID19 compared with healthy individuals.
Read the detailed description
This study was aimed to evaluate the post-infection cognitive functions of adult individuals with COVID-19. Fifty COVID-19 patients, aged between 18-50 years, who had positive RT-PCR test in the last 60 days and later recovered, were included in the study. The study group was compared with the control group consisting of 50 healthy individuals in whom gender, age and education year has not difference significantly. Participants' global cognitive skills were measured by the Montreal Cognitive Assessment Test (MoCA), the Clock Drawing Test and memory functions, the Öktem Verbal Memory Processes Test (Ö-SBST), the attention functions by the Digit Span Forward and Digit Span Backwards Test, the executive functions by Categorical Fluency, Phonemic Fluency, the Stroop Test, Trail Making Test A and B, visuospatial skills were evaluated with the Rey-Osterrieth Complex Figure Test (ROCF), and behavioral symptoms were evaluated with the Neuropsychiatric Inventory (NPI). The study group was evaluated between 21 and 60 days from the onset of the disease.
- Being tested
- Neuropsychometric Test
- Keywords
- Cognitive Functions, COVID-19, Attention, Executive Functions, Memory, Neurophysiology
- Medical subject headings
- Cognitive Dysfunction, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuropsychometric TestBehavioural
Also called Montreal Cognitive Assessment Test (MoCA), Clock Drawing Test, Öktem Verbal Memory Processes Test (Ö-SBST), Digit Span Forward Test
Participants' global cognitive skills were measured by the Montreal Cognitive Assessment Test (MoCA), the Clock Drawing Test and memory functions, the Öktem Verbal Memory Processes Test (Ö-SBST), the attention functions by the Digit Span Forward and Digit Span Backwards Test, the executive functions by Categorical Fluency, Phonemic Fluency, the Stroop Test, Trail Making Test A and B, visuospatial skills were evaluated with the Rey-Osterrieth Complex Figure Test (ROCF), and behavioral symptoms were evaluated with the Neuropsychiatric Inventory (NPI).
| Study group | Role | What they receive |
|---|---|---|
| Study Group | The study group consists of 50 individuals aged 18-50 years who have received a positive COVID-19 RT-PCR test in the past 60 days. Receives: Behavioral: Neuropsychometric Test | |
| Control Group | The control group consists of 50 healthy individuals aged 18-50 years who have not had COVID-19. Receives: Behavioral: Neuropsychometric Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Montreal Cognitive Assessment Test (MoCA)
It is a test that measures attention and concentration, executive functions, memory, language, visuospatial skills, abstract thinking, calculation and orientation skills in order to distinguish individuals with mild cognitive impairment from healthy individuals.
Measured: Any day between 21-60 days from the date of COVID-10 RT-PCR test positive.
Secondary outcomes (8)
Clock Drawing Test
The person is asked to draw a clock circle and place numbers in it. After succeeding, they are asked to show 11 by 10 crossing. This test can test comprehension, memory, visuospatial functions and executive functions.
Measured: Any day between 21-60 days from the date of COVID-10 RT-PCR test positive.
Öktem Verbal Memory Processes Test (Ö-SBST)
The test consists of fifteen unrelated words. Fifteen words are read to the subject at one-second intervals and then asked to say the ones that come to mind. In this process, information is collected about the subject's ability to maintain instant memory and attention. The number of correct answers of the subject is recorded as Instant Memory Score. After the first attempt, the same list is read to the subject nine more times, and each time he is asked to say all he remembers. This gives information about the subject's learning ability.
Measured: Any day between 21-60 days from the date of COVID-10 RT-PCR test positive.
Digit Span
The test consists of two parts as forward and backward span. In the forward digit span, the numbers are read at one second intervals and the patient is asked to repeat the randomly read numbers in the same order. It assesses attention and short-term memory. In the back digit span, it is requested to repeat the numbers read from the end to the beginning. Working memory is evaluated in the back count range. As the person succeeds in the trials, the test is continued by increasing one step. If the patient fails twice in a row for both sections, the test is discontinued.
Measured: Any day between 21-60 days from the date of COVID-10 RT-PCR test positive.
Verbal Fluency Test
Verbal fluency tests aim to evaluate the executive aspects of verbal behavior by using language capacity as a fluent speech. Verbal fluency tests are applied in two ways: phonemic fluency and semantic fluency. In the semantic fluency test, the person is asked to count animal names in one minute, and in the phonemic fluency test, the person is asked to produce words that start with a certain letter (K-A-S) and are not proper nouns.
Measured: Any day between 21-60 days from the date of COVID-10 RT-PCR test positive.
Stroop Test
The Stroop test evaluates focused attention, the ability to change attention in line with changing demands and under a distraction, the ability to suppress a habitual behavior pattern and perform an unusual behavior.
Measured: Any day between 21-60 days from the date of COVID-10 RT-PCR test positive.
Trail Making Test
The trail making test consists of two parts, A and B. In part A, the participants are asked to combine the circles with the numbers in the correct order and following each other (1-2-3-4-5...). In section B, there are letters and numbers placed in circles. Participants are asked to combine letters and numbers in the correct sequence (1-A-2-B-3-C-4-D...). The times of both sections are recorded. The A part of the IST evaluates the processing speed based on visual scanning ability, and the B part evaluates the complex attention, planning, set changing, blocking ability and following the sequentiality.
Measured: Any day between 21-60 days from the date of COVID-10 RT-PCR test positive.
Rey-Osterrieth Complex Figure Test (ROCF)
The purpose of the test is to evaluate visuospatial structuring skills and visual memory. The test material consists of a complex shape printed on a card, a registration form, an identification form with 24 details, three blank sheets of paper, a pencil and an eraser. The subject is first asked to copy the complex shape and the copying time is noted. During copying, the subject is not informed that he will draw the shape again. In the next step, the complex shape is removed and the person is asked to draw the shape again as far as he can remember, and the drawing time is noted. This is instant recall application. After the instant recall, the subject is not informed that he will draw the shape again, and the subject's mind is occupied by introducing different tests. After 30 minutes, he is asked to draw again. This is the delayed recall phase.
Measured: Any day between 21-60 days from the date of COVID-10 RT-PCR test positive.
Neuropsychiatric Inventory (NPI)
The scale is scored by interview with the patient's relative. A total of 12 behavioral domains (delusions, hallucinations, agitation/aggression, depression/dysphoria, anxiety, elation/euphoria, apathy, disinhibition, irritability/lability, abnormal motor behavior, sleep/night behaviors, appetite and eating changes) are questioned.
Measured: Any day between 21-60 days from the date of COVID-10 RT-PCR test positive.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2021
- Study start15 Dec 2020
- Primary completion10 Jan 2021
- Study completion30 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COVID-19 Acute Respiratory Distress SyndromeStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medipol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Büşra Tüfekçi, Medipol University
- Investigators
- Büşra Tüfekçi, MD, Principal investigator, Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04978246
- Sponsor's protocol ID
- Medipol Mega3
- Status last verified
- Aug 2022
- First submitted
- 18 Jul 2021
- Last updated
- 5 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
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.
PubMed 32912598
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation Of Cognitive Functions In Adult Individuals With COVID-19
- ClinicalTrials.gov ID
- NCT04978246
- Acronym / sponsor ID
- Medipol Mega3
- Keywords
- Cognitive Functions, COVID-19, Attention, Executive Functions, Memory, Neurophysiology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Medipol UniversityUniversity, hospital or other
- Study start
- 15 Dec 2020 (actual)
- Primary completion
- 10 Jan 2021 (actual)
- Study completion
- 30 Jul 2021 (actual)
- First posted
- 27 Jul 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.
This study was aimed to evaluate the post-infection cognitive functions of adult individuals with COVID-19. 50 individuals with COVID-19 and 50 healthy control groups were included in the study. Cognitive functions of individuals with COVID19 compared with healthy individuals.
Detailed description
This study was aimed to evaluate the post-infection cognitive functions of adult individuals with COVID-19. Fifty COVID-19 patients, aged between 18-50 years, who had positive RT-PCR test in the last 60 days and later recovered, were included in the study. The study group was compared with the control group consisting of 50 healthy individuals in whom gender, age and education year has not difference significantly. Participants' global cognitive skills were measured by the Montreal Cognitive Assessment Test (MoCA), the Clock Drawing Test and memory functions, the Öktem Verbal Memory Processes Test (Ö-SBST), the attention functions by the Digit Span Forward and Digit Span Backwards Test, the executive functions by Categorical Fluency, Phonemic Fluency, the Stroop Test, Trail Making Test A and B, visuospatial skills were evaluated with the Rey-Osterrieth Complex Figure Test (ROCF), and behavioral symptoms were evaluated with the Neuropsychiatric Inventory (NPI). The study group was evaluated between 21 and 60 days from the onset of the disease.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study Group | – | Behavioral: Neuropsychometric TestThe study group consists of 50 individuals aged 18-50 years who have received a positive COVID-19 RT-PCR test in the past 60 days. |
| Control Group | – | Behavioral: Neuropsychometric TestThe control group consists of 50 healthy individuals aged 18-50 years who have not had COVID-19. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Community sample
Key inclusion criteria (3 listed)
- Having positive for the COVID-19 RT-PCR test and turned negative in the last 60 days.
- be 18-50 years old
- 21 days have passed since the onset of the disease
Key exclusion criteria (1 listed)
- Having any neurological or psychiatric illness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neuropsychometric TestAlso: Montreal Cognitive Assessment Test (MoCA), Clock Drawing Test, Öktem Verbal Memory Processes Test (Ö-SBST), Digit Span Forward TestParticipants' global cognitive skills were measured by the Montreal Cognitive Assessment Test (MoCA), the Clock Drawing Test and memory functions, the Öktem Verbal Memory Processes Test (Ö-SBST), the attention functions by the Digit Span Forward and Digit Span Backwards Test, the executive functions by Categorical Fluency, Phonemic Fluency, the Stroop Test, Trail Making Test A and B, visuospatial skills were evaluated with the Rey-Osterrieth Complex Figure Test (ROCF), and behavioral symptoms were evaluated with the Neuropsychiatric Inventory (NPI). | Behavioural | Control Group, Study Group |
Primary outcome
Montreal Cognitive Assessment Test (MoCA)
Time frame: Any day between 21-60 days from the date of COVID-10 RT-PCR test positive.
It is a test that measures attention and concentration, executive functions, memory, language, visuospatial skills, abstract thinking, calculation and orientation skills in order to distinguish individuals with mild cognitive impairment from healthy individuals.
8 secondary outcomes
Clock Drawing Test
Time frame: Any day between 21-60 days from the date of COVID-10 RT-PCR test positive.
Öktem Verbal Memory Processes Test (Ö-SBST)
Time frame: Any day between 21-60 days from the date of COVID-10 RT-PCR test positive.
Digit Span
Time frame: Any day between 21-60 days from the date of COVID-10 RT-PCR test positive.
Verbal Fluency Test
Time frame: Any day between 21-60 days from the date of COVID-10 RT-PCR test positive.
Stroop Test
Time frame: Any day between 21-60 days from the date of COVID-10 RT-PCR test positive.
Trail Making Test
Time frame: Any day between 21-60 days from the date of COVID-10 RT-PCR test positive.
Rey-Osterrieth Complex Figure Test (ROCF)
Time frame: Any day between 21-60 days from the date of COVID-10 RT-PCR test positive.
Neuropsychiatric Inventory (NPI)
Time frame: Any day between 21-60 days from the date of COVID-10 RT-PCR test positive.
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 5 Aug 2022.
- Results publication: 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.
- Individual participant dataSharing planned: Yes
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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.
Büşra Tüfekçi, MD principal investigator
Medipol University
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 COVID-19 Acute Respiratory Distress Syndrome and Cognitive Decline, run by Medipol University 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 3 inclusion and 1 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 5 Aug 2022. 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?
Montreal Cognitive Assessment Test (MoCA) (time frame: Any day between 21-60 days from the date of COVID-10 RT-PCR test positive.). 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 NCT04978246, which also lists 1 linked publication.
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 5 Aug 2022; AzTrials last refreshed its copy on 29 Oct 2026.