Healthy Volunteer COVID-19 Antibody Testing Study

NCT04529460 | Withdrawn

• 1 other identifier: 134035
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The need for large-scale testing for COVID-19 has been highlighted by both the World Health Organization (WHO) and the UK government. Immunity to coronavirus 2019 (COVID-19) infection can be determined by detecting the presence of antibodies to the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Immunoglobulins (Ig) to the SARS-CoV-2 develop during the second and third week of COVID-19 disease and can be detected by analyses conducted using laboratory tests. Accurate and scalable point-of-care testing (POCT) for the diagnosis of COVID-19 immunity would allow community diagnostic to be upscaled enormously. POCT for COVID-19 antibodies is possible using small disposable kits. POCT immunity testing using disposable kits will be imperative for effective surveillance and vaccinations programmes. The study aims to test a novel, rapid antibody testing kit (IgG and IgM) in order to confirm its accuracy in a healthy volunteer population. The antibody testing kit intended for use in the study has already been CE marked for this purpose.

Conditions

Covid19

Outcome Measures

Primary Outcomes (1)

• Sensitivity and specificity of the COVID-19 antibody testing kit

  Immediate

Study Arms (2)

Previously COVID-19 positive

Previously confirmed PCR positive for COVID-19 And/or positive COVID-19 antibody test in the past six months

Diagnostic Test: COVID-19 antibody point of care test kit

Previously COVID19 negative

No previous symptoms of COVID-19

Diagnostic Test: COVID-19 antibody point of care test kit

Interventions

COVID-19 antibody point of care test kit DIAGNOSTIC_TEST

A disponible point of care test that identifies the presence of antibodies to COVID-19

Previously COVID-19 positive; Previously COVID19 negative

Eligibility Criteria

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

Study Population

Healthy volunteers

You may qualify if:

• Adult (aged ≥ 18 years) healthy volunteers.
• For the positive group: PCR confirmed COVID-19 infection and/or positive antibodies test in the past six months,
• For the negative group: Never had symptoms of COVID-19
• Able to attend hospital for a blood and finger-prick test

You may not qualify if:

• Current symptoms of COVID-19
• Positive COVID-19 test result in the last 14 days
• Receiving or have received immunosuppression (including systemic corticosteroids) in the last 12 months
• Children (aged \< 18years)
• Pregnancy
• Prisoners

Sponsors & Collaborators

• Royal Free Hospital NHS Foundation Trust: lead

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Daniel Martin, MB ChB

  Royal Free Hospital NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2020
• First Posted: August 27, 2020
• Study Start: September 1, 2020
• Primary Completion: January 29, 2021
• Study Completion: April 30, 2021
• Last Updated: October 14, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share