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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04342702
Other study ID # SAHoWMU-CR2020-NCP-202
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date March 16, 2020
Est. completion date March 2021

Study information

Verified date May 2020
Source Second Affiliated Hospital of Wenzhou Medical University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 504
Est. completion date March 2021
Est. primary completion date March 2021
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

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

Exclusion Criteria:

- Suspected cases of COVID-19

Study Design


Locations

Country Name City State
China The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University Wenzhou Zhejiang
China Wenzhou Medical University Wenzhou Zhejiang

Sponsors (9)

Lead Sponsor Collaborator
Second Affiliated Hospital of Wenzhou Medical University Cangnan Hospital of Wenzhou Medical University, First Affiliated Hospital of Wenzhou Medical University, Pingyang Hospital of Wenzhou Medical University, Ruian Hospital of Wenzhou Medical University, Wenzhou Central Hospital And Sixth People's Hospital of Wenzhou Medical University, Wenzhou Medical University, Yongjia People's Hospital, Yueqing Hospital of Wenzhou Medical University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 36-Item Short Form Survey Instrument (SF-36) sum score of SF 36 form in each time frame one month, three month, six month and one year after discharge, minimum score
Primary the value of FEV1 by lung function test one month, three month, six month and one year after discharge
Primary the ratio of FEV1 to FVC by lung function test one month, three month, six month and one year after discharge
Secondary the predicted value of FEV1 by lung function test one month, three month, six month and one year after discharge
Secondary the predicted ratio of FEV1 to FVC by lung function test one month, three month, six month and one year after discharge
Secondary Lymphocyte value laboratory result one month, three month, six month and one year after discharge
Secondary Neutrophil value laboratory result one month, three month, six month and one year after discharge
Secondary DDI value laboratory result one month, three month, six month and one year after discharge
Secondary the proportion of applying ACEIs/ARBs medication collect the number of applying ACEIs/ARBs medication and calculate the proportion from the date of hospital admission to the day of hospital discharge
Secondary number of clinical symptoms after hospital discharge clinical symptoms one month, three month, six month and one year after discharge
Secondary number of cases returning to positive result in RT-PCR test one month, three month, six month and one year after discharge
Secondary Number of positive outcome of IgG for antibody of COVID-19 one month, three month, six month and one year after discharge
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