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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04342702
Recruitment Status : Active, not recruiting
First Posted : April 13, 2020
Last Update Posted : May 5, 2020
Sponsor:
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
Information provided by (Responsible Party):
Xiaokun Li, Wenzhou Medical University

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.

Condition or disease
Follow-up COVID-19 Infectious Diseases Respiratory

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.

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Study Type : Observational
Actual Enrollment : 504 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Study on the Prospective Cohort Library of Novel Coronavirus Pneumonia in Southeran
Actual Study Start Date : March 16, 2020
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : March 2021



Primary Outcome Measures :
  1. 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

  2. the value of FEV1 by lung function test [ Time Frame: one month, three month, six month and one year after discharge ]
  3. the ratio of FEV1 to FVC by lung function test [ Time Frame: one month, three month, six month and one year after discharge ]

Secondary Outcome Measures :
  1. the predicted value of FEV1 by lung function test [ Time Frame: one month, three month, six month and one year after discharge ]
  2. the predicted ratio of FEV1 to FVC by lung function test [ Time Frame: one month, three month, six month and one year after discharge ]
  3. Lymphocyte value [ Time Frame: one month, three month, six month and one year after discharge ]
    laboratory result

  4. Neutrophil value [ Time Frame: one month, three month, six month and one year after discharge ]
    laboratory result

  5. DDI value [ Time Frame: one month, three month, six month and one year after discharge ]
    laboratory result

  6. 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

  7. number of clinical symptoms after hospital discharge [ Time Frame: one month, three month, six month and one year after discharge ]
    clinical symptoms

  8. number of cases returning to positive result in RT-PCR test [ Time Frame: one month, three month, six month and one year after discharge ]
  9. Number of positive outcome of IgG for antibody of COVID-19 [ Time Frame: one month, three month, six month and one year after discharge ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Suspected cases of COVID-19

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04342702


Locations
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China, Zhejiang
Wenzhou Medical University
Wenzhou, Zhejiang, China, 325035
The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China
Sponsors and Collaborators
Second Affiliated Hospital of Wenzhou Medical University
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
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Responsible Party: Xiaokun Li, Professor, Wenzhou Medical University
ClinicalTrials.gov Identifier: NCT04342702    
Other Study ID Numbers: SAHoWMU-CR2020-NCP-202
First Posted: April 13, 2020    Key Record Dates
Last Update Posted: May 5, 2020
Last Verified: May 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Communicable Diseases
Infection