COVID-19 SARS-CoV-2 Antibody Testing Study

NCT05009888 | Unknown

• 1 other identifier: 302225
• Study Type: observational
• Target: 400
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (2)

• o Representativeness of participants psychological and behavioural reaction to the testing procedure, their test results, and their willingness to be re-tested.

  1 Year

• o Representativeness of participants sampled

  1 Year

Study Arms (1)

Adult KCL IoPPN Staff

Freely consenting Adult KCL Staff attending King's College London, IoPPN, Denmark Hill site will all have an antibody test on finger prick blood. The antibody test will give a rapid result for the presence of IgG or IgM antibodies to COVID-19

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Staff members based at the Institute of Psychiatry, Psychology and Neuroscience (IoPPN).

You may qualify if:

• King's College Staff member
• Aged 18 years or over
• Able to freely give informed consent

You may not qualify if:

• 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.

Sponsors & Collaborators

• King's College London: lead

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2021
• First Posted: August 18, 2021
• Study Start: August 1, 2021
• Primary Completion: August 1, 2022
• Study Completion: August 1, 2022
• Last Updated: August 18, 2021

Record last verified: 2021-08