Long-term Outcomes in Patients With COVID-19

• Conditions: COVID-19

• Registration Number: NCT04508712
• Lead Sponsor: RenJi Hospital

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.

Study Timeline

• Study First Submitted: 2020-08-08
• Study Start: 2020-08-10
• Study First Submitted QC: 2020-08-10
• Study First Posted: 2020-08-11
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-22
• Last Update Posted: 2020-10-23
• Primary Completion: 2021-08-31
• Study Completion: 2021-08-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 900

Inclusion Criteria

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

Exclusion Criteria

• Patients who were < 18 years

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Physical functions	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	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	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	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	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	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.

Trial Locations

Locations (1)

Renji Hospital, Shanghai Jiaotong University School of Medicine; 🇨🇳 Pudong, Shanghai, China