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

COVID-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04342702
• Other study ID #: SAHoWMU-CR2020-NCP-202
• Status: Active, not recruiting
• 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
• 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

Related Conditions & MeSH terms

• Communicable Diseases
• COVID-19
• Follow-up
• Infection
• Infectious Diseases
• Respiratory

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