Clincosm LogoSign in Get a demo

Long-term Follow-up Study of COVID-19

Sponsor
Tongji Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05986435
Collaborator
(none)
5,700
Enrollment
2
Locations
38.3
Anticipated Duration (Months)
2850
Patients Per Site
74.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The goal of this observational study is to learn the long-term prognosis of patients and the clinical characteristics of complications, which is of great significance for treatment of novel coronavirus infection pneumonia.

This trial plans to include 5700 inpatients with positive SARS CoV-2 nucleic acid test results. This trial does not involve the use of specific drug. Participants's health and psychological status will be observed at the preset time points. The blood, feces, urine samples of patients will be collected for relevant tests.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    After the patients are enrolled, record the patient's treatment regimens, blood routine results, blood biochemistry results, cytokines results, lung imaging results, and cranial imaging results, understand the patient's current clinical manifestations, evaluate the patient's psychological status and quality of life, and collect samples of the patients' blood, feces, urine, and other related tests.

    Collection of clinical samples: collect blood, urine, throat swabs and other samples from patients with confirmed novel coronavirus pneumonia (Nucleic acid test positive), and collect samples for relevant tests at 3 months, 6 months, 12 months, 18 months, 24 months and 36 months after discharge of patients, and record the clinical manifestations of patients.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    5700 participants
    Observational Model:
    Other
    Time Perspective:
    Other
    Official Title:
    Long-term Large Sample Multicenter Follow-up Study of COVID-19
    Actual Study Start Date :
    Oct 20, 2020
    Anticipated Primary Completion Date :
    Dec 31, 2023
    Anticipated Study Completion Date :
    Dec 31, 2023

    Outcome Measures

    Primary Outcome Measures

    1. clinical manifestation [3 months, 6 months, 12 months, 18 months, 24 months, 36 months after patients discharge]

    Secondary Outcome Measures

    1. psychological status [3 months, 6 months, 12 months, 18 months, 24 months, 36 months after patients discharge]

    2. quality of life scores [3 months, 6 months, 12 months, 18 months, 24 months, 36 months after patients discharge]

    3. cranial imaging results [3 months, 6 months, 12 months, 18 months, 24 months, 36 months after patients discharge]

    4. lung imaging results [3 months, 6 months, 12 months, 18 months, 24 months, 36 months after patients discharge]

    5. cytokines level [3 months, 6 months, 12 months, 18 months, 24 months, 36 months after patients discharge]

    6. blood biochemistry results [3 months, 6 months, 12 months, 18 months, 24 months, 36 months after patients discharge]

    7. routine blood test results [3 months, 6 months, 12 months, 18 months, 24 months, 36 months after patients discharge]

    8. treatment regimens [3 months, 6 months, 12 months, 18 months, 24 months, 36 months after patients discharge]

    9. survival rate [3 months, 6 months, 12 months, 18 months, 24 months, 36 months after patients discharge]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Patients with confirmed COVID-19
    Exclusion Criteria:
    • Combined infection with influenza virus, mycoplasma, and chlamydia.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology Wuhan Hu Bei Province China
    2 Wuhan Seventh Hospital Wuhan Hu Bei Province China

    Sponsors and Collaborators

    • Tongji Hospital

    Investigators

    • Principal Investigator: Qin Ning, Professor, Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Qin Ning, Director, department of infection, Tongji Hospital
    ClinicalTrials.gov Identifier:
    NCT05986435
    Other Study ID Numbers:
    • PROCOVER
    First Posted:
    Aug 14, 2023
    Last Update Posted:
    Aug 14, 2023
    Last Verified:
    Jul 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    COVID-19

    Study Results

    No Results Posted as of Aug 14, 2023