Neurocognitive Functions of Recovered COVID-19 Patients

• Conditions: Covid-19; Cognition
• Interventions: Behavioral: Trier Social Stress Test

• Registration Number: NCT04622748
• Lead Sponsor: National Institute on Drug Dependence, China

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-07-10
• Status Verified: 2020-09
• Study First Submitted: 2020-09-06
• Study First Submitted QC: 2020-11-08
• Last Update Submitted: 2020-11-08
• Study First Posted: 2020-11-10
• Last Update Posted: 2020-11-10
• Primary Completion: 2020-12-10
• Study Completion: 2020-12-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 160

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
COVID-19	Trier Social Stress Test	Recovered COVID-19 patients in Wuhan
Healthy Control	Trier Social Stress Test	Uninfected people in Wuhan

Primary Outcome Measures

Name	Time	Method
working memory	10 minutes	assessed by the n-back task, including 0-back, 1-back and 2-back
Cognitive flexibility	3 minutes	assessed by the trail-making task
Inhibitory control	10 minutes	assessed by the stroop task

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Wuhan Wuchang Hospital; 🇨🇳 Wuhan, Hubei, China