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Clinical Trials/NCT05986435
NCT05986435
Recruiting
Not Applicable

Long-term Large Sample Multicenter Follow-up Study of COVID-19

Tongji Hospital2 sites in 1 country5,700 target enrollmentOctober 20, 2020
ConditionsCOVID-19

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
COVID-19
Sponsor
Tongji Hospital
Enrollment
5700
Locations
2
Primary Endpoint
clinical manifestation
Status
Recruiting
Last Updated
2 years ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
October 20, 2020
End Date
December 31, 2023
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Qin Ning

Director, department of infection

Tongji Hospital

Eligibility Criteria

Inclusion Criteria

  • Patients with confirmed COVID-19

Exclusion Criteria

  • Combined infection with influenza virus, mycoplasma, and chlamydia.

Outcomes

Primary Outcomes

clinical manifestation

Time Frame: 3 months, 6 months, 12 months, 18 months, 24 months, 36 months after patients discharge

Secondary Outcomes

  • psychological status(3 months, 6 months, 12 months, 18 months, 24 months, 36 months after patients discharge)
  • routine blood test results(3 months, 6 months, 12 months, 18 months, 24 months, 36 months after patients discharge)
  • quality of life scores(3 months, 6 months, 12 months, 18 months, 24 months, 36 months after patients discharge)
  • cranial imaging results(3 months, 6 months, 12 months, 18 months, 24 months, 36 months after patients discharge)
  • blood biochemistry results(3 months, 6 months, 12 months, 18 months, 24 months, 36 months after patients discharge)
  • treatment regimens(3 months, 6 months, 12 months, 18 months, 24 months, 36 months after patients discharge)
  • survival rate(3 months, 6 months, 12 months, 18 months, 24 months, 36 months after patients discharge)
  • lung imaging results(3 months, 6 months, 12 months, 18 months, 24 months, 36 months after patients discharge)
  • cytokines level(3 months, 6 months, 12 months, 18 months, 24 months, 36 months after patients discharge)

Study Sites (2)

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