Study on the Antibody Level Against SARS-CoV-2 （COVID-19）in Dazhu County in 2023
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
|
Detailed Description
Data of the following will be collected:
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Demographic data,including Name, Gender, Ethnic groups, ID Card number (age automatically calculated), Height/weight (automatic BMI calculation);
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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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| ≥ 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. |
Outcome Measures
Primary Outcome Measures
- Concentration of antibody against SARS-CoV-2 [From Day 0 to Day 180]
Concentration of antibody against SARS-CoV-2 in different age groups
Secondary Outcome Measures
- Relation between collected information and antibody concentration [From Day 0 to Day 180]
Analysis of the correlation between the antibody level and the collected information.
Eligibility Criteria
Criteria
Inclusion Criteria:
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The age when signing ICF should be ≥3 year, male or female.
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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.
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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:
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a history of contraindications for venous blood collection such as thrombocytopenia or other clotting disorders.
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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.
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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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Dazhu County Center for Disease Control and Prevention | Dazhou | Sichuan | China | 635100 |
Sponsors and Collaborators
- Sinocelltech Ltd.
Investigators
- Principal Investigator: Bo Zhou, M.D., Dazhu County Center for Disease Control and Prevention
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SCT-Dazhu-Screening-1