Clinical trial NCT04342702: A Study on the Prospective Cohort Library of COVID-19 in Southeran
Official title: A Study on the Prospective Cohort Library of Novel Coronavirus Pneumonia in Southeran
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Follow-up
COVID-19
Infectious Diseases
Respiratory
Lead sponsor: Second Affiliated Hospital of Wenzhou Medical University
Sponsor class: OTHER
Collaborators: name: Wenzhou Medical University
name: First Affiliated Hospital of Wenzhou Medical University
name: Wenzhou Central Hospital And Sixth People's Hospital of Wenzhou Medical University
name: Yueqing Hospital of Wenzhou Medical University
name: Ruian Hospital of Wenzhou Medical University
name: Cangnan Hospital of Wenzhou Medical University
name: Pingyang Hospital of Wenzhou Medical University
name: Yongjia People's Hospital
First posted: 2020-04-13
Enrollment: 504
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Suspected cases of COVID-19

Primary outcomes:
measure: 36-Item Short Form Survey Instrument (SF-36)
timeFrame: one month, three month, six month and one year after discharge, minimum score
measure: the value of FEV1 by lung function test
timeFrame: one month, three month, six month and one year after discharge
measure: the ratio of FEV1 to FVC by lung function test
timeFrame: one month, three month, six month and one year after discharge
Secondary outcomes:
measure: the predicted value of FEV1 by lung function test
timeFrame: one month, three month, six month and one year after discharge
measure: the predicted ratio of FEV1 to FVC by lung function test
timeFrame: one month, three month, six month and one year after discharge
measure: Lymphocyte value
timeFrame: one month, three month, six month and one year after discharge
measure: Neutrophil value
timeFrame: one month, three month, six month and one year after discharge
measure: DDI value
timeFrame: one month, three month, six month and one year after discharge
measure: the proportion of applying ACEIs/ARBs medication
timeFrame: from the date of hospital admission to the day of hospital discharge
measure: number of clinical symptoms after hospital discharge
timeFrame: one month, three month, six month and one year after discharge
measure: number of cases returning to positive result in RT-PCR test
timeFrame: one month, three month, six month and one year after discharge
measure: Number of positive outcome of IgG for antibody of COVID-19
timeFrame: one month, three month, six month and one year after discharge
Other outcomes:
Locations:
city: Wenzhou
country: China
facility: Wenzhou Medical University
state: Zhejiang
city: Wenzhou
country: China
facility: The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University
state: Zhejiang
Study officials:
References: