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Clinical Trials/NCT04508712
NCT04508712
Unknown
Not Applicable

Long-term Outcomes in Patients With COVID-19

RenJi Hospital1 site in 1 country900 target enrollmentAugust 10, 2020
ConditionsCOVID-19

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
COVID-19
Sponsor
RenJi Hospital
Enrollment
900
Locations
1
Primary Endpoint
Physical functions
Last Updated
5 years ago

Overview

Brief Summary

Long-term outcomes from coronavirus disease 2019 (COVID-19) are currently unknown. This study will collect daily living status of survivors of COVID-19.

Detailed Description

The ongoing pandemic of coronavirus disease 2019 (COVID-19), due to the newly discovered severe acute respiratory syndrome coronavirus 2 (SAR-CoV-2), has caused a worldwide increase in hospitalization for pneumonia with multi- organ disease. Survival from sepsis is associated with increased risk for mortality for at least 2 years. Therefore, substantial sequelae including new physical disability, new cognitive impairment and increased vulnerability to further health deterioration are likely to be seen in survivors of COVID-19. The investigators conduct this study to investigate daily living status of survivors of COVID-19 using telephone interview questionnaire including Activity Daily Living(ADL), modified Medical Research Council(mMRC),modified Telephone Interview for Cognitive Status (TICS-m), Zung Self-rating Depression Scale(SDS), Carcinologic Handicap Index (CHI), and New York Heart Association (NYHA) functional class.

Registry
clinicaltrials.gov
Start Date
August 10, 2020
End Date
August 31, 2021
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Survivors who had been admitted in Leishenshan Hospital for COVID-19 patients in Wuhan, China

Exclusion Criteria

  • Patients who were \< 18 years

Outcomes

Primary Outcomes

Physical functions

Time Frame: 4-6 months

Physical functions will be assessed using Activities of daily living (ADL) scale. Minimum value:0, Maximum value: 100. Higher scores mean a better outcome.

Cognitive function

Time Frame: 4-6 months

Cognitive function will be assessed using modified Telephone Interview for Cognitive Status (TICS-m) scale. Minimum value:0, Maximum value: 50. Higher scores mean a better outcome.

Depression status

Time Frame: 4-6 months

Depression status will be assessed using Zung Self-rating Depression Scale(SDS). Minimum value:25, Maximum value: 125. Higher scores mean a worse outcome.

Sensory functions

Time Frame: 4-6 months

Sensory functions will be assessed using Carcinologic Handicap Index (CHI). Minimum value:0, Maximum value: 144. Higher scores mean a worse outcome.

Heart function

Time Frame: 4-6 months

Heart function will be assessed using New York Heart Association (NYHA) functional class. Minimum value:1, Maximum value: 4. Higher scores mean a worse outcome.

Respiratory function

Time Frame: 4-6 months

Respiratory function will be assessed using modified Medical Research Council(mMRC) scale. Minimum value:0, Maximum value: 4. Higher scores mean a worse outcome.

Study Sites (1)

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