NCT04508712

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
900

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 8, 2020

Completed
2 days until next milestone

Study Start

First participant enrolled

August 10, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 11, 2020

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2021

Completed
Last Updated

October 23, 2020

Status Verified

October 1, 2020

Enrollment Period

1.1 years

First QC Date

August 8, 2020

Last Update Submit

October 22, 2020

Conditions

Keywords

COVID-19long-term outcomes

Outcome Measures

Primary Outcomes (6)

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

This study will enroll survivors of COVID-19 aged over 18 years old who had been admitted in Leishenshan Hospital for COVID-19 patients in Wuhan, China.

You may qualify if:

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

You may not qualify if:

  • Patients who were \< 18 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Renji Hospital, Shanghai Jiaotong University School of Medicine

Pudong, Shanghai Municipality, 200127, China

RECRUITING

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Weifeng Yu, MD,PhD

    Renji Hospital, School of Medicine, Shanghai Jiaotong University, China

    STUDY DIRECTOR

Central Study Contacts

Diansan Su, MD,PhD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
6 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 8, 2020

First Posted

August 11, 2020

Study Start

August 10, 2020

Primary Completion

August 31, 2021

Study Completion

August 31, 2021

Last Updated

October 23, 2020

Record last verified: 2020-10

Locations