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

Study Overview
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Brief Summary
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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.

Detailed Description
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Data of the following will be collected: Demographic data,including Name, Gender, Ethnic groups, ID Card number (age automatically calculated), Height/weight (automatic BMI calculation); 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.

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

Conditions
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COVID-19

Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| ≥ 60 years old population<br>around 2000 subjects will be screened. | |
| 18 59 years old population<br>around 3000 subjects will be screened. | |
| < 18 years old<br>around 15000 subjects will be screened. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Concentration of antibody against SARS-CoV-2 | 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 | Analysis of the correlation between the antibody level and the collected information. | From Day 0 to Day 180 |