To optimise and undertake clinical validation of a new point-of-care diagnostic test for COVID-19 (CoOp study).

Not Applicable

Recruiting

• Conditions: SARS-CoV-2 infection in respiratory samples; COVID-19; Infection - Other infectious diseases; Respiratory - Other respiratory disorders / diseases

• Registration Number: ACTRN12623000107628
• Lead Sponsor: ZiP Diagnostics Pty Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-01-31
• Last Update Posted: 6 February 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

This is a prospective observational cohort study seeking recruitment of up to 150 SARS-CoV-2 positive adults within the Alfred Hospital care pathway. Study participants will have a clinical encounter across two timepoints, the first time point occurring within 5 days after testing positive for COVID-19 (acute-phase) and the second time point occurring when negative; at least 3 weeks after testing positive for COVID-19 (convalescent phase).

Acute-phase encounter:
•Participants have been tested for SARS-CoV-2 (RAT or PCR) in the last 5 days.
•Participants have provided verbal informed consent.
•18 years of age or older
•Participant has a suitable location where the study sample kit can be dropped-off and collected in an area that is accessible and safe for researchers.

Convalescent-phase encounter:
•Participants have previously provided samples during acute-phase of the study but there have been at least 3 weeks since the acute-phase sampling.
•Participants have provided verbal informed consent.
•18 years of age or older

Exclusion Criteria

< 18 years.

Study & Design

• Study Type: Observational
• Study Design: Not specified