COVID-19 SARS-CoV-2 Antibody Testing Study

Healthy Clinical Trial

— SATS  

Official title:

COVID-19 SARS-CoV-2 Antibody Testing Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05009888
• Other study ID #: 302225
• Status: Not yet recruiting
• Start date: August 2021
• Est. completion date: August 2022

Study information

• Verified date: August 2021
• Source: King's College London
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

SATS is a single site feasibility study to assess the practical and psychological feasibility of using rapid COVID antibody testing of blood obtained from fingertip pin-pricks.

Description:

SATS is a feasibility study conducted at a single site - King's College London and South London and Maudsley staff working at the Institute of Psychiatry, Psychology and Neuroscience (IoPPN) at Denmark Hill, London, England. The practical and psychological feasibility of using rapid COVID antibody testing of blood obtained from fingertip pin-pricks will be assessed.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 400
• Est. completion date: August 2022
• Est. primary completion date: August 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• King's College Staff member

• Aged 18 years or over

• Able to freely give informed consent

Exclusion Criteria:

The participant may not enter the study if ANY of the following apply:

• known to have an infectious disease including a current SARS-CoV-2 infection.

• Any significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the research study, or may influence the result of the research study, or the participant's ability to participate in the research study. Examples of disorders or diseases which would be excluded include:

• Medically diagnosed bleeding disorder;

• Medically diagnosed platelet disorder;

• Anticoagulant medication.

Related Conditions & MeSH terms

• Healthy

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
King's College London

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acceptability of performing antibody testing procedures involving a capillary blood sample collected via finger-prick	o Acceptability would be represented by the number of participants who consent to and complete the antibody testing procedure.	1 Year
Primary	Test validity of the antibody tests that are performed	the number of completed tests that are valid with a positive/negative IgG/IgM result and confirmed with a positive control line compared with invalid test results as confirmed with a negative control result.	1 Year
Secondary	o Representativeness of participants psychological and behavioural reaction to the testing procedure, their test results, and their willingness to be re-tested.	Assessed by psychometric testing using visual analogue scales	1 Year
Secondary	o Representativeness of participants sampled	This would be assessed using demographic data collected from participant	1 Year