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

Prognosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05004246
• Other study ID #: TJ20210622
• Status: Enrolling by invitation
• Start date: March 15, 2021
• Est. completion date: December 31, 2025

Study information

• Verified date: March 2024
• Source: Tongji Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 1000
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

Suspected cases of COVID-19.

Related Conditions & MeSH terms

• COVID-19
• Prognosis
• Sequelae

Locations

Country	Name	City	State
China	Department of infectious disease, Tongji Hospital	Wuhan	Hubei

Sponsors (8)

Lead Sponsor	Collaborator
Tongji Hospital	First Affiliated Hospital of Wenzhou Medical University, First Affiliated Hospital Xi'an Jiaotong University, Shanxi Bethune Hospital, WUHAN Number Seven HOSPITAL, Xiangya Hospital of Central South University, Yichang Central People's Hospital, Yunnan Provincial Infectious Disease Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	symptoms and signs	symptoms and signs will be collected.	1-3years
Primary	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
Primary	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
Primary	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, ?-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
Primary	Radiological findings	Radiological findings such as chest computed tomography will be assessed.	1-3years
Primary	pulmonary function	pulmonary function tests will be assessed.	1-3years
Primary	Heart function	electrocardiogram including arrhythmia,ST-T change and conduction block will be assessed.(they have no Units)	1-3years
Primary	Abdominal ultrasound	Abdominal ultrasound will be assessed.	1-3years