NCT04342702

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
504

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2020

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 16, 2020

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

April 4, 2020

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 13, 2020

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2021

Completed
Last Updated

May 5, 2020

Status Verified

May 1, 2020

Enrollment Period

12 months

First QC Date

April 4, 2020

Last Update Submit

May 3, 2020

Conditions

Follow-upCOVID-19Infectious DiseasesRespiratory

Outcome Measures

Primary Outcomes (3)

  • 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

  • the value of FEV1 by lung function test

    one month, three month, six month and one year after discharge

  • the ratio of FEV1 to FVC by lung function test

    one month, three month, six month and one year after discharge

Secondary Outcomes (9)

  • the predicted value of FEV1 by lung function test

    one month, three month, six month and one year after discharge

  • the predicted ratio of FEV1 to FVC by lung function test

    one month, three month, six month and one year after discharge

  • Lymphocyte value

    one month, three month, six month and one year after discharge

  • Neutrophil value

    one month, three month, six month and one year after discharge

  • DDI value

    one month, three month, six month and one year after discharge

  • +4 more secondary outcomes

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • Suspected cases of COVID-19

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Wenzhou Medical University

Wenzhou, Zhejiang, 325035, China

Location

The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, China

Location

MeSH Terms

Conditions

COVID-19Communicable Diseases

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 4, 2020

First Posted

April 13, 2020

Study Start

March 16, 2020

Primary Completion

March 1, 2021

Study Completion

March 1, 2021

Last Updated

May 5, 2020

Record last verified: 2020-05

Locations

CN(2)