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

Sponsor
Tongji Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05004246
Collaborator
First Affiliated Hospital Xi'an Jiaotong University (Other), Yichang Central People's Hospital (Other), First Affiliated Hospital of Wenzhou Medical University (Other), Xiangya Hospital of Central South University (Other), Shiyan Renmin Hospital (Other), The second Hospital of JingZhou (Other), Yunnan Provincial Infectious Disease Hospital (Other), WUHAN Number Seven HOSPITAL (Other), Shanxi Bethune hospital, Shanxi, China (Other)
1,000
1
26.5
37.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    1000 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Longitudinal Changes in Characteristics of COVID-19 Survivors and Their Long-term Follow-up Study
    Actual Study Start Date :
    Mar 15, 2021
    Anticipated Primary Completion Date :
    Jun 1, 2023
    Anticipated Study Completion Date :
    Jun 1, 2023

    Outcome Measures

    Primary Outcome Measures

    1. symptoms and signs [1-3years]

      symptoms and signs will be collected.

    2. Quality 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.

    3. 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.

    4. 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).

    5. Radiological findings [1-3years]

      Radiological findings such as chest computed tomography will be assessed.

    6. pulmonary function [1-3years]

      pulmonary function tests will be assessed.

    7. Heart function [1-3years]

      electrocardiogram including arrhythmia,ST-T change and conduction block will be assessed.

    8. Abdominal ultrasound [1-3years]

      Abdominal ultrasound will be assessed.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

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

    Exclusion Criteria:

    Suspected cases of COVID-19.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Department of infectious disease, Tongji Hospital Wuhan Hubei China 430030

    Sponsors and Collaborators

    • Tongji Hospital
    • First Affiliated Hospital Xi'an Jiaotong University
    • Yichang Central People's Hospital
    • First Affiliated Hospital of Wenzhou Medical University
    • Xiangya Hospital of Central South University
    • Shiyan Renmin Hospital
    • The second Hospital of JingZhou
    • Yunnan Provincial Infectious Disease Hospital
    • WUHAN Number Seven HOSPITAL
    • Shanxi Bethune hospital, Shanxi, China

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Qin Ning, Director of Department of Infectious Diseases, Tongji Hospital
    ClinicalTrials.gov Identifier:
    NCT05004246
    Other Study ID Numbers:
    • TJ20210622
    First Posted:
    Aug 13, 2021
    Last Update Posted:
    Aug 13, 2021
    Last Verified:
    Jun 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Qin Ning, Director of Department of Infectious Diseases, Tongji Hospital
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 13, 2021