Evaluating new point-of-care diagnostic tests for COVID-19
Not Applicable
Completed
- Conditions
- COVID-19 (SARS-CoV-2 infection)Infections and Infestations
- Registration Number
- ISRCTN86124626
- Lead Sponsor
- Manchester University NHS Foundation Trust
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 1000
Inclusion Criteria
Patients presenting to secondary/tertiary care with possible SARS-CoV-2 infection who require testing, in the opinion of the treating clinician. Those patients may have presented with acute symptoms of COVID-19 (e.g. fever, cough, dyspnoea) or they may be asymptomatic, but require testing for other reasons
Exclusion Criteria
1. Impossible or unsafe to obtain the required research samples
2. Prisoners
3. Patients with confirmed previous infection to SARS-CoV-2
4. Patients where sampling is not feasible
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Standard” diagnostic accuracy of point-of-care tests for active and past COVID-19 infection with reference to the Public Health England reference standard; Timepoint(s): Baseline, Day 1, Day 3, Day 5 Day 9, Day 30 and Day 90
- Secondary Outcome Measures
Name Time Method 1. Detection of antibodies to SARS-CoV-2 by a reference method<br>2. Length of hospital stay measured using clinical notes<br>3. Development of multi-organ failure measured using clinical notes<br>4. Critical care admission measured using clinical notes<br>5. Mechanical ventilation measured using clinical notes<br>6. Organ support measured using clinical notes<br>7. Vasopressor use measured using clinical notes<br>8. SARS-CoV-2 related death measured using clinical notes<br>Timepoint(s): Day 30 and Day 90