Longitudinal Changes in Characteristics of COVID-19 Survivors and Their Long-term Follow-up Study

NCT05004246 | Enrolling By Invitation

• 1 other identifier: TJ20210622
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

Follow-up study of Coronavirus disease 2019 (COVID-19) survivors has rarely been reported. We aimed to investigate longitudinal changes in the characteristics of COVID-19 survivors after discharge.

Conditions

Prognosis; Sequelae

Keywords

COVID-19; follow-up; consequences

Outcome Measures

Primary Outcomes (8)

• symptoms and signs

  symptoms and signs will be collected.

  1-3years

• SF-36 Questionnaire to the ability of Life

  Quality of Life will be assesed using the MOS item short from health survey（SF-36.Minimum value:0, Maximum value: 100. Higher scores mean a better outcome.

  1-3years

• Mental quality

  Mental quality will be assessed using hospital anxiety and depression scale.Minimum value:0, Maximum value: 21. Higher scores mean a worse outcome.

  1-3years

• laboratory findings,change from baseline for blood laboratory measures

  the change from baseline for laboratory examination （Hb in g/L, Leukocyte in /L, neutrophil count in /L，lymphocyte count in /L，Platelet count in /L，Creatinine in μmol/L, Bilirubin in mg/dL, ALP in U/L, γ-glutamyl transpeptidase in U/L，AST in U/L, ALT in U/L, Albumin in g/dL, triglycerides in mmol/L, total cholesterol in mmol/L，cardiac troponin I in ng/mL， myoglobin in ng/mL， brain natriuretic peptide precursors in pg/mL， lactate dehydrogenase in U/L, Creatine Kinase in U/L).

  1-3years

• Radiological findings

  Radiological findings such as chest computed tomography will be assessed.

  1-3years

• pulmonary function

  pulmonary function tests will be assessed.

  1-3years

• Heart function

  electrocardiogram including arrhythmia,ST-T change and conduction block will be assessed.（they have no Units）

  1-3years

• Abdominal ultrasound

  Abdominal ultrasound will be assessed.

  1-3years

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This study will enroll recovered patients with confirmed COVID-19 who were discharged from Hospital.

You may qualify if:

• Patients with confirmed COVID-19 who have complete hospitalization data.

You may not qualify if:

• Suspected cases of COVID-19.

Sponsors & Collaborators

• Tongji Hospital: lead
• First Affiliated Hospital Xi'an Jiaotong University: collaborator
• Yichang Central People's Hospital: collaborator
• First Affiliated Hospital of Wenzhou Medical University: collaborator
• Xiangya Hospital of Central South University: collaborator
• Yunnan Provincial Infectious Disease Hospital: collaborator
• WUHAN Number Seven HOSPITAL: collaborator
• Shanxi Bethune Hospital: collaborator

Study Sites (1)

Department of infectious disease, Tongji Hospital

Wuhan, Hubei, 430030, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

peripheral blood mononuclear cell (PBMC)

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Department of Infectious Diseases

Study Record Dates

• First Submitted: July 21, 2021
• First Posted: August 13, 2021
• Study Start: March 15, 2021
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: March 18, 2024

Record last verified: 2024-03

Locations

CN (1)