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Clinical Trials/NCT05004246
NCT05004246
Enrolling By Invitation
Not Applicable

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

Tongji Hospital1 site in 1 country1,000 target enrollmentMarch 15, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Prognosis
Sponsor
Tongji Hospital
Enrollment
1000
Locations
1
Primary Endpoint
symptoms and signs
Status
Enrolling By Invitation
Last Updated
2 years ago

Overview

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.

Detailed Description

From December 2019, coronavirus disease 2019 (COVID-19), caused by a β-coronavirus known as severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), has spread across the globe. Numerous studies have been performed so far to investigate clinical characteristics, risk factors, potential treatment and pathogenesis of COVID-19. However, little information is available on the long-term prognosis and possible sequelae of COVID-19 survivors who have recovered and been discharged from hospital. Hence, the investigators conducted a prospective study to investigate the long-time prognosis and the possible sequelae of COVID-19 survivors. The investigators evaluated Demographic and clinical characteristics, laboratory and radiological findings,pulmonary function tests, electrocardiogram, complications as well as treatment and symptoms and signs of COVID-19 patients.

Registry
clinicaltrials.gov
Start Date
March 15, 2021
End Date
December 31, 2025
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Qin Ning

Director of Department of Infectious Diseases

Tongji Hospital

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • Suspected cases of COVID-19.

Outcomes

Primary Outcomes

symptoms and signs

Time Frame: 1-3years

symptoms and signs will be collected.

Mental quality

Time Frame: 1-3years

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

SF-36 Questionnaire to the ability of Life

Time Frame: 1-3years

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.

laboratory findings,change from baseline for blood laboratory measures

Time Frame: 1-3years

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).

Heart function

Time Frame: 1-3years

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

Radiological findings

Time Frame: 1-3years

Radiological findings such as chest computed tomography will be assessed.

pulmonary function

Time Frame: 1-3years

pulmonary function tests will be assessed.

Abdominal ultrasound

Time Frame: 1-3years

Abdominal ultrasound will be assessed.

Study Sites (1)

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