Long-term Outcomes in Patients With COVID-19

COVID-19 Clinical Trial

Official title:

Long-term Outcomes in Patients With COVID-19

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04508712
• Other study ID #: COVID-19 Prognosis
• Status: Recruiting
• Start date: August 10, 2020
• Est. completion date: August 31, 2021

Study information

• Verified date: October 2020
• Source: RenJi Hospital
• Contact: Diansan Su, MD,PhD
• Phone: +8618616514088
• Email: diansansu[@]yahoo.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 900
• Est. completion date: August 31, 2021
• Est. primary completion date: August 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Patients who were < 18 years

Related Conditions & MeSH terms

• COVID-19

Locations

Country	Name	City	State
China	Renji Hospital, Shanghai Jiaotong University School of Medicine	Pudong	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
RenJi Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Physical functions	Physical functions will be assessed using Activities of daily living (ADL) scale. Minimum value:0, Maximum value: 100. Higher scores mean a better outcome.	4-6 months
Primary	Respiratory function	Respiratory function will be assessed using modified Medical Research Council(mMRC) scale. Minimum value:0, Maximum value: 4. Higher scores mean a worse outcome.	4-6 months
Primary	Cognitive function	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.	4-6 months
Primary	Depression status	Depression status will be assessed using Zung Self-rating Depression Scale(SDS). Minimum value:25, Maximum value: 125. Higher scores mean a worse outcome.	4-6 months
Primary	Sensory functions	Sensory functions will be assessed using Carcinologic Handicap Index (CHI). Minimum value:0, Maximum value: 144. Higher scores mean a worse outcome.	4-6 months
Primary	Heart function	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.	4-6 months