Neurocognitive Functions of Recovered COVID-19 Patients

Covid-19 Clinical Trial

Official title:

An Investigation of Neurocognitive Functions and the Influencing Factors in Recovered Patients With COVID-19

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04622748
• Other study ID #: NIDD-2020-Neurocognition
• Status: Recruiting
• Start date: July 10, 2020
• Est. completion date: December 10, 2020

Study information

• Verified date: September 2020
• Source: National Institute on Drug Dependence, China
• Contact: Ping Wu, Dr.
• Phone: 861082802470
• Email: wuping[@]bjmu.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: December 10, 2020
• Est. primary completion date: December 10, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cognition
• Covid-19

Intervention

Behavioral:
• Trier Social Stress Test
8-min oral calculation and 5-min speech

Locations

Country	Name	City	State
China	Wuhan Wuchang Hospital	Wuhan	Hubei

Sponsors (3)

Lead Sponsor	Collaborator
National Institute on Drug Dependence, China	Peking University Sixth Hospital, Wuhan Wuchang Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.
Other	Stress response indicator 2	Hear rates	Assessed before and 0 minute after stress
Other	Stress response indicator 3	Blood pressure before stress and after stress	Assessed before and 0 minute after stress
Primary	working memory	assessed by the n-back task, including 0-back, 1-back and 2-back	10 minutes
Primary	Cognitive flexibility	assessed by the trail-making task	3 minutes
Primary	Inhibitory control	assessed by the stroop task	10 minutes
Secondary	Attention Bias	assessed by the dot-probe task	15 minutes
Secondary	Serum TNFalpha	Concentration of serum TNFalpha in ng/ml will be assessed by ELISA	1 day
Secondary	Serum IL-6	Concentration of serum IL-6 in ng/ml will be assessed by ELISA.	1 day
Secondary	CRP	hypersensitive C-reactive protein(hs-CRP) in mg/L will be assessed by Turbidimetric inhibition immuno assay.	1 day
Secondary	Depression	assessed by Self-Rating Depression Scale, which is consist of 20 items scoring 1 to 4.	3-5 minutes
Secondary	Anxiety	assessed by Self-Rating Anxiety Scale, which is consist of 20 items scoring 1 to 4.	3-5 minutes
Secondary	PTSD	assessed by PTSD Checklist for DSM-5 (PCL-5)	3-5 minutes
Secondary	Sleep	assessed by Pittsburgh sleep quality index (PSQI)	3-5 minutes
Secondary	General cognition	assessed by Montreal - Cognitive Assessment (MoCA)	8-10 minutes
Secondary	Cardiopulmonary function 1	maximal inspiration pressure(MIP), maximal expiration pressure(MEP)	15 minutes
Secondary	Cardiopulmonary function 2	Assessed by the 6-minutes' walk test	10 minutes