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

COVID-19 Clinical Trial

— COVID-19  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05758675
• Other study ID #: SCT-Dazhu-Screening-1
• Status: Recruiting
• Start date: February 21, 2023
• Est. completion date: December 8, 2023

Study information

• Verified date: March 2023
• Source: Sinocelltech Ltd.
• Contact: Xinjie Yang, M.D.
• Phone: 86-010-58628288
• Email: xinjie_yang[@]sinocelltech.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20000
• Est. completion date: December 8, 2023
• Est. primary completion date: September 8, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Years to 120 Years

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19

Locations

Country	Name	City	State
China	Dazhu County Center for Disease Control and Prevention	Dazhou	Sichuan

Sponsors (1)

Lead Sponsor	Collaborator
Sinocelltech Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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