COVID-19 (SARS-CoV-2 infection) Infections and Infestations Coronavirus infection, unspecified site
Conditions
Interventions
Patients will have a nose and throat swab collected and tested immediately using the QIAstat-Dx Respiratory n-CoV Panel. Results are available in 1 hour and will be communicated immediately to clinica
patients tested in the same time period by the local laboratory by RT-PCR were assessed for eligibility for entering the control group.
Sponsors
University Hospital Southampton NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time from COVID-19 test being requested to the result being available to clinical teams in minutes and hours, recorded during hospitalisation | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 20/07/2020: Measured using retrospective analysis of case notes and hospital information systems and unless specified otherwise measured for the duration of hospitalisation or up to 30 days, whichever is shorter: 1. The time from presentation to hospital to COVID-19 test result 2. Time spent in COVID-19 assessment cohort area 3. Time to definitive ward move 4. Number of bed moves 5. Duration of hospitalisation 6. Number and proportion of clinically unsuspected COVID-19 positive patients detected 7. Proportion of patients treated with antibiotics 8. Proportion of patients treated with single doses or brief courses (<48 hours) of antibiotics 9. Duration of antibiotic use, days 10. Proportion of all influenza antiviral use occurring in influenza-positive patients 11. Proportion of all influenza antiviral use occurring in influenza-negative patients 12. Time from admission to influenza antiviral commencement 13. Duration of influenza antiviral use, days and doses 14. Proportion of patients with ICU or RHDU admission 15. Proportion readmitted to hospital within 30 days 16. In-hospital, 30- and 60-day mortality 17. Reliability (proportion of run failures), ease-of-use scores, and implementation feasibility assessment (narrative) of QIAstat-Dx Respiratory SARS-CoV-2 Panel, used at the point-of-care 18. Sensitivity, specificity, positive predicted value, negative predictive value, percentage positive agreement, percentage negative agreement, percentage overall agreement, and overall diagnostic accuracy of QIAstat-Dx SARS-CoV-2 assay (as part of QIAstat-Dx Respiratory SARS-CoV-2 Panel) compared to laboratory PCR using the PHE RdRP assay Previous secondary outcome measures: Measured using retrospective analysis of case notes and hospital information systems and unless specified otherwise measured for the duration of hospitalisation or up to 30 days, whichever is shorter: 1. The time from presentation to hospital to COVID-19 test resul | — |
Countries
England, United Kingdom
Outcome results
None listed