Neurocognitive Functions of Recovered COVID-19 Patients

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.

Study Overview

• Status: Unknown
• Conditions: Covid-19; Cognition
• Intervention / Treatment: Behavioral: Trier Social Stress Test

• Study Type: Observational
• Enrollment (Anticipated): 160

Contacts and Locations

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430063
      • Recruiting
      • Wuhan Wuchang Hospital
      • Contact: Guofu Huang, Dr; Phone Number: 8618162533930; Email: 94615617@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Recovered COVID-19 patients and uninfected residents in Wuhan

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
COVID-19; Recovered COVID-19 patients in Wuhan	Behavioral: Trier Social Stress Test; 8-min oral calculation and 5-min speech
Healthy Control; Uninfected people in Wuhan	Behavioral: Trier Social Stress Test; 8-min oral calculation and 5-min speech

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Attention Bias	assessed by the dot-probe task	15 minutes
Serum TNFalpha	Concentration of serum TNFalpha in ng/ml will be assessed by ELISA	1 day
Serum IL-6	Concentration of serum IL-6 in ng/ml will be assessed by ELISA.	1 day
CRP	hypersensitive C-reactive protein(hs-CRP) in mg/L will be assessed by Turbidimetric inhibition immuno assay.	1 day
Depression	assessed by Self-Rating Depression Scale, which is consist of 20 items scoring 1 to 4.	3-5 minutes
Anxiety	assessed by Self-Rating Anxiety Scale, which is consist of 20 items scoring 1 to 4.	3-5 minutes
PTSD	assessed by PTSD Checklist for DSM-5 (PCL-5)	3-5 minutes
Sleep	assessed by Pittsburgh sleep quality index (PSQI)	3-5 minutes
General cognition	assessed by Montreal - Cognitive Assessment (MoCA)	8-10 minutes
Cardiopulmonary function 1	maximal inspiration pressure（MIP), maximal expiration pressure（MEP）	15 minutes
Cardiopulmonary function 2	Assessed by the 6-minutes' walk test	10 minutes

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stress response indicator 1	concentration of saliva cortisol stress, assessed by ELISA	Saliva samples will be colleted before stress, 0 minutes and 10 minutes after stress.
Stress response indicator 2	Hear rates	Assessed before and 0 minute after stress
Stress response indicator 3	Blood pressure before stress and after stress	Assessed before and 0 minute after stress

Collaborators and Investigators

• Sponsor: National Institute on Drug Dependence, China
• Collaborators: Peking University Sixth Hospital; Wuhan Wuchang Hospital
• Investigators: Study Director: Lin Lu, Dr., National Institute on Drug Dependence, Peking University

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 10, 2020
• Primary Completion (ANTICIPATED): December 10, 2020
• Study Completion (ANTICIPATED): December 10, 2020

Study Registration Dates

• First Submitted: September 6, 2020
• First Submitted That Met QC Criteria: November 8, 2020
• First Posted (ACTUAL): November 10, 2020

Study Record Updates

• Last Update Posted (ACTUAL): November 10, 2020
• Last Update Submitted That Met QC Criteria: November 8, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: NIDD-2020-Neurocognition

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No