CognitionNCT04622748
Neurocognitive Functions of Recovered COVID-19 Patients
An observational study of Cognition and Covid-19, run by National Institute on Drug Dependence, China at 1 site in China.
Trial summary
This study is carried on in Wuchang Hospital in Wuhan, China. The investigators plan to recruit 80 patients with COVID-19 and 80 matched healthy control. Using the design of case-control study, the study aims to assess the neurocognitive functions such as executive function and attentional bias in recovered patients… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- What is being tested?
- Trier Social Stress Test
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- How many people
- 160 participants
- Where
- 1 siteChina
- Study dates
- 10 Jul 2020to 10 Dec 2020
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Recovered COVID-19 patients and uninfected residents in Wuhan
Who may be able to join
- Recovered COVID-19 patients or uninfected residents in Wuhan, with an education level above elementary school and are able to complete cognitive tasks;
- Willing to participate in this study and sign informed consent.
Who cannot join
- Subjects with body temperature> 38°C;
- Subjects who are in menstruation and pregnancy;
- Subjects suffering from cardiopulmonary diseases before the new coronary pneumonia epidemic (such as heart disease, pulmonary hypertension, congestive heart failure, etc.);
- Subjects with severe disturbances in consciousness, cognitive dysfunction, mental disorders, visual and hearing disorders, bone and joint diseases, etc.;
- Subjects with abnormal immune system and severe organ dysfunction (heart, liver, kidney, etc.);
- Subjects who are unwilling to participate in this study and cannot complete all surveys and cognitive function tests.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Wuhan Wuchang Hospital
Wuhan, Hubei, 430063
Guofu Huang, Dr, 8618162533930, 94615617@qq.com
About this study
Official title: An Investigation of Neurocognitive Functions and the Influencing Factors in Recovered Patients With COVID-19
This study is carried on in Wuchang Hospital in Wuhan, China. The investigators plan to recruit 80 patients with COVID-19 and 80 matched healthy control. Using the design of case-control study, the study aims to assess the neurocognitive functions such as executive function and attentional bias in recovered patients with COVID-19 under normal and stress conditions, and to analyze the influencing factors of neurocognitive functions, such as mental health conditions, inflammation indicators and cardiopulmonary function.
- Being tested
- Trier Social Stress Test
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trier Social Stress TestBehavioural
8-min oral calculation and 5-min speech
| Study group | Role | What they receive |
|---|---|---|
| COVID-19 | Recovered COVID-19 patients in Wuhan Receives: Behavioral: Trier Social Stress Test | |
| Healthy Control | Uninfected people in Wuhan Receives: Behavioral: Trier Social Stress Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
working memory
assessed by the n-back task, including 0-back, 1-back and 2-back
Measured: 10 minutes
Cognitive flexibility
assessed by the trail-making task
Measured: 3 minutes
Inhibitory control
assessed by the stroop task
Measured: 10 minutes
Secondary outcomes (11)
Attention Bias
assessed by the dot-probe task
Measured: 15 minutes
Serum TNFalpha
Concentration of serum TNFalpha in ng/ml will be assessed by ELISA
Measured: 1 day
Serum IL-6
Concentration of serum IL-6 in ng/ml will be assessed by ELISA.
Measured: 1 day
CRP
hypersensitive C-reactive protein(hs-CRP) in mg/L will be assessed by Turbidimetric inhibition immuno assay.
Measured: 1 day
Depression
assessed by Self-Rating Depression Scale, which is consist of 20 items scoring 1 to 4.
Measured: 3-5 minutes
Anxiety
assessed by Self-Rating Anxiety Scale, which is consist of 20 items scoring 1 to 4.
Measured: 3-5 minutes
PTSD
assessed by PTSD Checklist for DSM-5 (PCL-5)
Measured: 3-5 minutes
Sleep
assessed by Pittsburgh sleep quality index (PSQI)
Measured: 3-5 minutes
General cognition
assessed by Montreal - Cognitive Assessment (MoCA)
Measured: 8-10 minutes
Cardiopulmonary function 1
maximal inspiration pressure（MIP), maximal expiration pressure（MEP）
Measured: 15 minutes
Cardiopulmonary function 2
Assessed by the 6-minutes' walk test
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2020
- Study start10 Jul 2020
- Primary completion10 Dec 2020 (estimated)
- Study completion10 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CognitionStudies 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
- Cross-sectional
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Institute on Drug Dependence, China
- Sponsor type
- University, hospital or other
- Collaborators
- Peking University Sixth Hospital, Wuhan Wuchang Hospital
- Responsible party
- Sponsor
- Investigators
- Lin Lu, Dr., Study director, National Institute on Drug Dependence, Peking University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04622748
- Sponsor's protocol ID
- NIDD-2020-Neurocognition
- Status last verified
- Sep 2020
- First submitted
- 6 Sep 2020
- Last updated
- 10 Nov 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Investigation of Neurocognitive Functions and the Influencing Factors in Recovered Patients With COVID-19
- ClinicalTrials.gov ID
- NCT04622748
- Acronym / sponsor ID
- NIDD-2020-Neurocognition
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- National Institute on Drug Dependence, ChinaUniversity, hospital or other
- Collaborators
- Peking University Sixth Hospital, Wuhan Wuchang Hospital
- Study start
- 10 Jul 2020 (actual)
- Primary completion
- 10 Dec 2020 (estimated)
- Study completion
- 10 Dec 2020 (estimated)
- First posted
- 10 Nov 2020 (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 is carried on in Wuchang Hospital in Wuhan, China. The investigators plan to recruit 80 patients with COVID-19 and 80 matched healthy control. Using the design of case-control study, the study aims to assess the neurocognitive functions such as executive function and attentional bias in recovered patients with COVID-19 under normal and stress conditions, and to analyze the influencing factors of neurocognitive functions, such as mental health conditions, inflammation indicators and cardiopulmonary function.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| COVID-19 | – | Behavioral: Trier Social Stress TestRecovered COVID-19 patients in Wuhan |
| Healthy Control | – | Behavioral: Trier Social Stress TestUninfected people in Wuhan |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Recovered COVID-19 patients and uninfected residents in Wuhan
Key inclusion criteria (2 listed)
- Recovered COVID-19 patients or uninfected residents in Wuhan, with an education level above elementary school and are able to complete cognitive tasks;
- Willing to participate in this study and sign informed consent.
Key exclusion criteria (6 listed)
- Subjects with body temperature> 38°C;
- Subjects who are in menstruation and pregnancy;
- Subjects suffering from cardiopulmonary diseases before the new coronary pneumonia epidemic (such as heart disease, pulmonary hypertension, congestive heart failure, etc.);
- Subjects with severe disturbances in consciousness, cognitive dysfunction, mental disorders, visual and hearing disorders, bone and joint diseases, etc.;
- Subjects with abnormal immune system and severe organ dysfunction (heart, liver, kidney, etc.);
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 |
|---|---|---|
| Trier Social Stress Test8-min oral calculation and 5-min speech | Behavioural | COVID-19, Healthy Control |
Primary outcome
working memory
Time frame: 10 minutes
assessed by the n-back task, including 0-back, 1-back and 2-back
Cognitive flexibility
Time frame: 3 minutes
assessed by the trail-making task
Inhibitory control
Time frame: 10 minutes
assessed by the stroop task
11 secondary outcomes
Attention Bias
Time frame: 15 minutes
Serum TNFalpha
Time frame: 1 day
Serum IL-6
Time frame: 1 day
CRP
Time frame: 1 day
Depression
Time frame: 3-5 minutes
Anxiety
Time frame: 3-5 minutes
PTSD
Time frame: 3-5 minutes
Sleep
Time frame: 3-5 minutes
General cognition
Time frame: 8-10 minutes
Cardiopulmonary function 1
Time frame: 15 minutes
Cardiopulmonary function 2
Time frame: 10 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2020.
- Individual participant dataSharing planned: No
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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.
Lin Lu, Dr. study director
National Institute on Drug Dependence, Peking 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 Cognition and Covid-19, run by National Institute on Drug Dependence, China at 1 site in China.
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 2 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 10 Nov 2020. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ping Wu, Dr. (861082802470 ext. 509, wuping@bjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
working memory (time frame: 10 minutes). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Nov 2020.