Does point-of-care testing for coronavirus in hospital improve patient care compared to laboratory testing?

Not Applicable

Completed

• Conditions: COVID-19 (SARS-CoV-2 infection); Infections and Infestations; Coronavirus infection, unspecified site

• Registration Number: ISRCTN14966673
• Lead Sponsor: niversity Hospital Southampton NHS Foundation Trust

Brief Summary

2020 Results article in https://pubmed.ncbi.nlm.nih.gov/33038974/ results (added 13/10/2020) 2021 Results article in https://pubmed.ncbi.nlm.nih.gov/34363885/ SARS-CoV-2 Viral load at presentation to hospital is independently associated with the risk of death (added 09/08/2021) 2022 Results article in https://pubmed.ncbi.nlm.nih.gov/35534764/ Combined RT-PCR and Host Response Point-of-Care Testing in Patients Hospitalised with Suspected COVID-19: A Prospective Diagnostic Accuracy Study (added 10/05/2022) 2020 Other publications in https://pubmed.ncbi.nlm.nih.gov/32998038/ Comparison of patients with and without SARS-CoV-2 infection (added 08/04/2024) 2020 Results article in https://pubmed.ncbi.nlm.nih.gov/32579983/ (added 08/04/2024)

Detailed Description

Not available

Study Timeline

• Study Start: 2020-03-18
• Study Completion: 2021-04-01
• Last Update Posted: 22 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 1055

Inclusion Criteria

1. Is a patient in ED, AMU, HDU, GICU, medical wards, or another location within Southampton General Hospital, University Hospital Southampton NHS Foundation Trust (UHS)
2. Aged =18 years old
3. Can be recruited to the study within 24 hours of presentation to hospital
Plus:
4. Has acute respiratory illness (ARI)*
OR
5. Does not have ARI but is a suspected case of COVID-19 according to the current PHE case definition OR
6. Does not have ARI or fulfil the PHE case definition of a suspected case but testing for SARS-CoV-2 is considered necessary by the responsible clinical team
*An episode of acute respiratory illness is defined as an acute upper or lower respiratory illness (including rhinitis, rhino-sinusitis, pharyngitis, pneumonia, bronchitis and influenza-like illness) or an acute exacerbation of a chronic respiratory illness (including exacerbation of COPD, asthma or bronchiectasis). For the study, acute respiratory illness as a provisional, working, differential or confirmed diagnosis must be made by a treating clinician

Staff testing
Non-hospitalised hospital staff members may be included in the post-implementation phase of the study, if they satisfy the other inclusion and exclusion criteria

Exclusion Criteria

1. Not fulfilling all the inclusion criteria
2. Declines nasal/pharyngeal swabbing
3. Consent declined or consultee consent declined
4. Already recruited to the study in the last 30 days

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time from COVID-19 test being requested to the result being available to clinical teams in minutes and hours, recorded during hospitalisation