NCT04622748

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
160

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 10, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 6, 2020

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 10, 2020

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 10, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 10, 2020

Completed
Last Updated

November 10, 2020

Status Verified

September 1, 2020

Enrollment Period

5 months

First QC Date

September 6, 2020

Last Update Submit

November 8, 2020

Conditions

CognitionCovid-19

Outcome Measures

Primary Outcomes (3)

  • working memory

    assessed by the n-back task, including 0-back, 1-back and 2-back

    10 minutes

  • Cognitive flexibility

    assessed by the trail-making task

    3 minutes

  • Inhibitory control

    assessed by the stroop task

    10 minutes

Secondary Outcomes (11)

  • Attention Bias

    15 minutes

  • Serum TNFalpha

    1 day

  • Serum IL-6

    1 day

  • CRP

    1 day

  • Depression

    3-5 minutes

  • +6 more secondary outcomes

Other Outcomes (3)

  • Stress response indicator 1

    Saliva samples will be colleted before stress, 0 minutes and 10 minutes after stress.

  • Stress response indicator 2

    Assessed before and 0 minute after stress

  • Stress response indicator 3

    Assessed before and 0 minute after stress

Study Arms (2)

COVID-19

Recovered COVID-19 patients in Wuhan

Behavioral: Trier Social Stress Test

Healthy Control

Uninfected people in Wuhan

Behavioral: Trier Social Stress Test

Interventions

Trier Social Stress TestBEHAVIORAL

8-min oral calculation and 5-min speech

COVID-19Healthy Control

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Recovered COVID-19 patients and uninfected residents in Wuhan

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wuhan Wuchang Hospital

Wuhan, Hubei, 430063, China

RECRUITING

MeSH Terms

Conditions

COVID-19

Interventions

Psychological Tests

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Behavioral Disciplines and Activities

Study Officials

  • Lin Lu, Dr.

    National Institute on Drug Dependence, Peking University

    STUDY DIRECTOR

Central Study Contacts

Ping Wu, Dr.

CONTACT

861082802470wuping@bjmu.edu.cn

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 6, 2020

First Posted

November 10, 2020

Study Start

July 10, 2020

Primary Completion

December 10, 2020

Study Completion

December 10, 2020

Last Updated

November 10, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)