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

NCT ID: NCT05758675

Last Updated: 2023-03-08

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 20000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-02-21
• Study Completion Date: 2023-12-08

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.

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.

Conditions

COVID-19

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

≥ 60 years old population

around 2000 subjects will be screened.

No interventions assigned to this group

18~59 years old population

around 3000 subjects will be screened.

No interventions assigned to this group

< 18 years old

around 15000 subjects will be screened.

No interventions assigned to this group

Eligibility Criteria

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.

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sinocelltech Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bo Zhou, M.D.

Role: PRINCIPAL_INVESTIGATOR

Dazhu County Center for Disease Control and Prevention

Locations

Dazhu County Center for Disease Control and Prevention

Dazhou, Sichuan, China

Site Status: RECRUITING

Countries

China

Central Contacts

Xinjie Yang, M.D.

Role: CONTACT

xinjie_yang@sinocelltech.com

86-010-58628288

Facility Contacts

Bo Zhou, Bachelor's

Role: primary

Other Identifiers

SCT-Dazhu-Screening-1

Identifier Type: -

Identifier Source: org_study_id