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

• Conditions: Prognosis; Sequelae

• Registration Number: NCT05004246
• Lead Sponsor: Tongji Hospital

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.

Study Timeline

• Study Start: 2021-03-15
• Study First Submitted: 2021-07-21
• Study First Submitted QC: 2021-08-12
• Study First Posted: 2021-08-13
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-15
• Last Update Posted: 2024-03-18
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

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

Exclusion Criteria

Suspected cases of COVID-19.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
symptoms and signs	1-3years	symptoms and signs will be collected.
Mental quality	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	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	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	1-3years	electrocardiogram including arrhythmia,ST-T change and conduction block will be assessed.（they have no Units）
Radiological findings	1-3years	Radiological findings such as chest computed tomography will be assessed.
pulmonary function	1-3years	pulmonary function tests will be assessed.
Abdominal ultrasound	1-3years	Abdominal ultrasound will be assessed.

Trial Locations

Locations (1)

Department of infectious disease, Tongji Hospital; 🇨🇳 Wuhan, Hubei, China