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临床试验/NCT05004246
NCT05004246Enrolling By Invitation不适用

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

Tongji Hospital1 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2021年3月15日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
1,000
试验地点
1
主要终点
symptoms and signs

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

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

排除标准

  • Suspected cases of COVID-19.

结局指标

主要结局

symptoms and signs

时间窗: 1-3years

symptoms and signs will be collected.

Mental quality

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 1-3years

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

Radiological findings

时间窗: 1-3years

Radiological findings such as chest computed tomography will be assessed.

pulmonary function

时间窗: 1-3years

pulmonary function tests will be assessed.

Abdominal ultrasound

时间窗: 1-3years

Abdominal ultrasound will be assessed.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Qin Ning

Director of Department of Infectious Diseases

Tongji Hospital

研究点 (1)

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