Study evaluating Coronavirus (COVID-19) nasal/oral swab results compared to blood antibody results in COVID-19 clinic patients.

Not Applicable

Completed

• Conditions: Infection - Other infectious diseases; Coronavirus Disease 19 (COVID-19); SARS-CoV-2; Public Health - Other public health; Respiratory - Other respiratory disorders / diseases

• Registration Number: ACTRN12620000487910
• Lead Sponsor: Albury Wodonga Health

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-04-20
• Study Completion: 2021-01-23
• Last Update Posted: 15 May 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 103

Inclusion Criteria

• Participants aged 18 years or over
• Participants who have attended Albury-Wodonga Health Coronavirus Screening clinic and have had a NP swab collected for SARS-CoV-2 NAT
.• Both participants that have returned a negative or a positive swab will be included in the study.
• Participants must be accessible for follow up testing
• Able to read, write and understand English Participant Information and Consent Form
• Signed Participant Information and Consent Form

Exclusion Criteria

• Participants under 18 years of age
• Unwilling to be contacted for follow up testing
• Medical or psychiatric condition or occupational responsibilities that may preclude compliance with the protocol
• Research study personnel as identified in this Protocol

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To determine proportion of people with nucleic acid test (NAT) negative nasopharyngeal swab for SARS-CoV-2 (nasopharyngeal NAT) while exhibiting symptoms consistent with COVID-19 disease who then develop SARS-CoV-2 antibody seroconversion prior to, and during, the development of widespread community transmission.[Approximately 14 to 28 days after developing Coronavirus symptoms]

Secondary Outcome Measures

Name	Time	Method
To collect epidemiological and symptom data to determine if there are potential prognostic and diagnostic variables. There may be common trends with regard to transmission and presentation of the virus that have not been previously identified. Data to be collected for the study will include general patient demographics, medical history, SARS-CoV-2 NAT pathology results, SARS-CoV-2 Risk assessment and symptom assessment.[Measured over duration of trial - approximately 12 months from last patient registered]