A Study on the Prospective Cohort Library of COVID-19 in Southeran

May 3, 2020 updated by: Xiaokun Li, Second Affiliated Hospital of Wenzhou Medical University

A Study on the Prospective Cohort Library of Novel Coronavirus Pneumonia in Southeran

This is a multi-centre population-based follow-up study for all 504 patients with laboratory-confirmed COVID-19. This study establishes a standardized and structured clinical database to provide complete and multidimensional clinical diagnosis and treatment data of novel coronavirus pneumonia, which also support future epidemiological, infectious disease study and patients' prognosis, by collecting clinical data and the related data of patients with novel coronavirus pneumonia in Southern Zhejiang province.

Study Overview

Status

Unknown

Conditions

Detailed Description

The follow-up information will be collected in one-month, three-month, six-month and one-year after discharge. Information about symptoms, radiographic and laboratory findings, lung function, SF-36 QUESTIONNAIRE, antibody of COVID19，result of RT-PCR Test and suvival information will be collected through all time frames.

Study Type

Observational

Enrollment (Actual)

504

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Zhejiang
      • Wenzhou, Zhejiang, China, 325035
        • Wenzhou Medical University
      • Wenzhou, Zhejiang, China
        • The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Among all 504 patients with laboratory-confirmed COVID-19, 190 patients were classified as the imported cohort, and 311 patients were classified into the secondary cohort, three patients were excluded. The patients' inclusion cutoff was March 15, 2020.

Description

Inclusion Criteria:

  • All patients with laboratory-confirmed COVID-19 in Wenzhou

Exclusion Criteria:

  • Suspected cases of COVID-19

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
36-Item Short Form Survey Instrument (SF-36)
Time Frame: one month, three month, six month and one year after discharge, minimum score
sum score of SF 36 form in each time frame
one month, three month, six month and one year after discharge, minimum score
the value of FEV1 by lung function test
Time Frame: one month, three month, six month and one year after discharge
one month, three month, six month and one year after discharge
the ratio of FEV1 to FVC by lung function test
Time Frame: one month, three month, six month and one year after discharge
one month, three month, six month and one year after discharge

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the predicted value of FEV1 by lung function test
Time Frame: one month, three month, six month and one year after discharge
one month, three month, six month and one year after discharge
the predicted ratio of FEV1 to FVC by lung function test
Time Frame: one month, three month, six month and one year after discharge
one month, three month, six month and one year after discharge
Lymphocyte value
Time Frame: one month, three month, six month and one year after discharge
laboratory result
one month, three month, six month and one year after discharge
Neutrophil value
Time Frame: one month, three month, six month and one year after discharge
laboratory result
one month, three month, six month and one year after discharge
DDI value
Time Frame: one month, three month, six month and one year after discharge
laboratory result
one month, three month, six month and one year after discharge
the proportion of applying ACEIs/ARBs medication
Time Frame: from the date of hospital admission to the day of hospital discharge
collect the number of applying ACEIs/ARBs medication and calculate the proportion
from the date of hospital admission to the day of hospital discharge
number of clinical symptoms after hospital discharge
Time Frame: one month, three month, six month and one year after discharge
clinical symptoms
one month, three month, six month and one year after discharge
number of cases returning to positive result in RT-PCR test
Time Frame: one month, three month, six month and one year after discharge
one month, three month, six month and one year after discharge
Number of positive outcome of IgG for antibody of COVID-19
Time Frame: one month, three month, six month and one year after discharge
one month, three month, six month and one year after discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Second Affiliated Hospital of Wenzhou Medical University

Collaborators

Wenzhou Medical University
First Affiliated Hospital of Wenzhou Medical University
Wenzhou Central Hospital And Sixth People's Hospital of Wenzhou Medical University
Yueqing Hospital of Wenzhou Medical University
Ruian Hospital of Wenzhou Medical University
Cangnan Hospital of Wenzhou Medical University
Pingyang Hospital of Wenzhou Medical University
Yongjia People's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 16, 2020

Primary Completion (ANTICIPATED)

March 1, 2021

Study Completion (ANTICIPATED)

March 1, 2021

Study Registration Dates

First Submitted

April 4, 2020

First Submitted That Met QC Criteria

April 9, 2020

First Posted (ACTUAL)

April 13, 2020

Study Record Updates

Last Update Posted (ACTUAL)

May 5, 2020

Last Update Submitted That Met QC Criteria

May 3, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SAHoWMU-CR2020-NCP-202

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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