Clinical trial NCT04622748: Neurocognitive Functions of Recovered COVID-19 Patients
Official title: An Investigation of Neurocognitive Functions and the Influencing Factors in Recovered Patients With COVID-19
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cognition
Covid-19
Lead sponsor: National Institute on Drug Dependence, China
Sponsor class: OTHER
Collaborators: name: Peking University Sixth Hospital
name: Wuhan Wuchang Hospital
First posted: 2020-11-10
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Recovered COVID-19 patients and uninfected residents in Wuhan

Brief 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 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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: working memory
timeFrame: 10 minutes
measure: Cognitive flexibility
timeFrame: 3 minutes
measure: Inhibitory control
timeFrame: 10 minutes
Secondary outcomes:
measure: Attention Bias
timeFrame: 15 minutes
measure: Serum TNFalpha
timeFrame: 1 day
measure: Serum IL-6
timeFrame: 1 day
measure: CRP
timeFrame: 1 day
measure: Depression
timeFrame: 3-5 minutes
measure: Anxiety
timeFrame: 3-5 minutes
measure: PTSD
timeFrame: 3-5 minutes
measure: Sleep
timeFrame: 3-5 minutes
measure: General cognition
timeFrame: 8-10 minutes
measure: Cardiopulmonary function 1
timeFrame: 15 minutes
measure: Cardiopulmonary function 2
timeFrame: 10 minutes
Other outcomes:
measure: Stress response indicator 1
timeFrame: Saliva samples will be colleted before stress, 0 minutes and 10 minutes after stress.
measure: Stress response indicator 2
timeFrame: Assessed before and 0 minute after stress
measure: Stress response indicator 3
timeFrame: Assessed before and 0 minute after stress
Locations:
city: Wuhan
country: China
facility: Wuhan Wuchang Hospital
state: Hubei
Study officials:
affiliation: National Institute on Drug Dependence, Peking University
name: Lin Lu, Dr.
role: STUDY_DIRECTOR
References: