A Follow-up Study of Asymptomatic Infections and Diagnosed Patients With Covid-19 in Shanghai

May 23, 2022 updated by: Ruijin Hospital
This study is to clarify the distribution characteristics, host and clinical characteristics, disease outcome and risk factors, changes of multiple organs such as cardiopulmonary function and changes in social and psychological indicators during long-term follow-up of omicron variant asymptomatic infections and diagnosed patients

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

250000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Shanghai, China
        • Recruiting
        • Ruijin Hospital
        • Contact:
        • Principal Investigator:
          • Guang Ning, Ph D
        • Principal Investigator:
          • Erzhen CHEN, Ph D

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

asymptomatic infections and diagnosed patients with COVID-19 in fangcang shelter hospitals in Shanghai

Description

Inclusion Criteria:

  • SARS-Cov-2-RNA positive
  • informed consent signed

Exclusion Criteria:

  • informed consent rejected

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
COVID-19 infections
SARS-Cov-2 RNA postive

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
long-term outcomes，changes of clinical characteristic and social psychology
Time Frame: 10 years
the 3rd，6th，9th month，average one year discharge from hospital
10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ruijin Hospital

Investigators

  • Principal Investigator: Guang Ning, Ph D, Ruijin Hospital
  • Principal Investigator: Erzhen CHEN, Ph D, Ruijin Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 29, 2022

Primary Completion (Anticipated)

May 31, 2032

Study Completion (Anticipated)

May 31, 2032

Study Registration Dates

First Submitted

May 23, 2022

First Submitted That Met QC Criteria

May 23, 2022

First Posted (Actual)

May 24, 2022

Study Record Updates

Last Update Posted (Actual)

May 24, 2022

Last Update Submitted That Met QC Criteria

May 23, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SCAM2022-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

The data are not publicity available due to privacy and ethical restrictions

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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