Study on the Antibody Level Against SARS-CoV-2 （COVID-19）in Dazhu County in 2023 (COVID-19)

March 2, 2023 updated by: Sinocelltech Ltd.

Study on the Antibody Level Against SARS-CoV-2 in Dazhu County in 2023

About 15,000 to 25,000 subjects will be screened. Their information will be collected, venous blood will be sampled, their serum antibody levels will be detected, and the incidence of COVID-19 wil be followed up.

Study Overview

Status

Not yet recruiting

Conditions

Detailed Description

Data of the following will be collected:

  1. Demographic data,including Name, Gender, Ethnic groups, ID Card number (age automatically calculated), Height/weight (automatic BMI calculation);
  2. Previous disease/surgical history; 3. Previous COVID-19 infections; 4. COVID-19 vaccination history; 5. Infection after this screening; 6. Screening information for COVID-19 antibodies.

Atibody level against SARS-CoV-2 will be test.

Study Type

Observational

Enrollment (Anticipated)

20000

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
    • Sichuan
      • Dazhou, Sichuan, China, 635100
        • Dazhu County Center for Disease Control and Prevention
        • Contact:
          • Bo Zhou, Bachelor's

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

3 years to 120 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Screening by sampling from natural communities.

Description

Inclusion Criteria:

  • The age when signing ICF should be ≥3 year, male or female.
  • The Subject and/or guardian or client of both parties are able to sign a written ICF and voluntarily participate in the trial, fully understand the trial procedure, the risks of participating in the study.
  • Healthy subjects or subjects with stable underlying diseases. Stable underlying diseases were defined as those who were in stable condition at least 3 months before inclusion in the study, had no significant change in treatment regimen and had not been admitted to hospital due to disease progression.

Exclusion Criteria:

  • a history of contraindications for venous blood collection such as thrombocytopenia or other clotting disorders.
  • Current severe or uncontrollable cardiovascular disease, endocrine disease, blood and lymphatic system disease, liver and kidney disease, respiratory system disease, metabolic and skeletal system disease, or malignancy.
  • If it is not in line with the benefit maximization of the subjects, the investigator determines that it is not suitable to participate in clinical research.

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

Cohorts and Interventions

Group / Cohort
≥ 60 years old population
around 2000 subjects will be screened.
18~59 years old population
around 3000 subjects will be screened.
< 18 years old
around 15000 subjects will be screened.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Concentration of antibody against SARS-CoV-2
Time Frame: From Day 0 to Day 180
Concentration of antibody against SARS-CoV-2 in different age groups
From Day 0 to Day 180

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Relation between collected information and antibody concentration
Time Frame: From Day 0 to Day 180
Analysis of the correlation between the antibody level and the collected information.
From Day 0 to Day 180

Collaborators and Investigators

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

Sponsor

Sinocelltech Ltd.

Investigators

  • Principal Investigator: Bo Zhou, M.D., Dazhu County Center for Disease Control and Prevention

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 (Anticipated)

March 8, 2023

Primary Completion (Anticipated)

September 8, 2023

Study Completion (Anticipated)

November 8, 2023

Study Registration Dates

First Submitted

February 13, 2023

First Submitted That Met QC Criteria

March 2, 2023

First Posted (Estimate)

March 7, 2023

Study Record Updates

Last Update Posted (Estimate)

March 7, 2023

Last Update Submitted That Met QC Criteria

March 2, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SCT-Dazhu-Screening-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Distribution analysis and correlation analysis of antibody will be done and published in academic journals.

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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