Understanding Infection, Viral Exacerbation and Respiratory Symptoms at Admission- Longitudinal (UNIVERSAL) Study
The global burden of hospital admissions due to respiratory viral illnesses is considerable across the lifespan, with treatmentÌý options such as vaccination being mainly supportive. Response to infection is variable, with some experiencing only mild symptoms that do not require admission, whilst others develop a severe response to infection and require higher level care. Rates of complications from respiratory viral infections appear comparable to influenza, suggesting greater attention needs to be focussed on non-influenza respiratory viral illness.
The recent pandemic highlighted the need to link clinical care with research for more rapid translation of new treatment discoveries. The majority of winter pressures facing NHS acute trusts are as a result of acute respiratory viral infection. A better understanding of the natural history of acute respiratory viral infection and recovery will facilitate improved clinical management with the potential to identify options for intervention in those at risk of more severe disease, with resultant health economic benefits.
Primary:
Secondary:
Tertiary:
UNIVERSAL is an observational cohort study looking at individuals who are admitted to hospital with a suspected respiratory viral infection (RVI) UK-wide. Patients who test positive for an RVI will complete questionnaires related to their health and wellbeing as well as provide samples at three timepoints while in hospital. This will help to develop a better understanding of respiratory viral infection and recovery as well as facilitate improved clinical management, develop novel intervention strategies and better estimate healthcare cost based on patient characteristics.
Open to recruitment
Individuals admitted to hospital with a suspected respiratory viral infection.
This study is funded by Janssen Pharmaceuticals, AstraZeneca, Sanofi, GlaxoSmithKline and Synairgen.
Senior Trial Manager:
Pedro Rodrigues
Trial Manager:
Abigail Jones
Clinical Data Coordinator:
Alex Allen
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Email: universal@soton.ac.uk
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Email: ctu@soton.ac.uk
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Study Documents
UNIVERSAL - Protocol, v9 17-Jul-2025
UNIVERSAL - PI Protocol Acknowledgement Form, v2 20-Aug-2025
UNIVERSAL - Delegation Log, v2 06-Jul-2022
UNIVERSAL - Training Log, v1 15-Dec-2022
UNIVERSAL - Screening Log, v1 06-Jul-2022
UNIVERSAL - Recruitment Tracker, v1 11-Nov-2022
UNIVERSAL - GP Letter, v2 28-Aug-2025
UNIVERSAL - Serious Adverse Event Report Form, v0.1 04-Mar-2022
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Manuals
UNIVERSAL - Laboratory Manual, v5 17-Jul-2025
UNIVERSAL - BioFire Guidance, v3 08-Nov-2024
UNIVERSAL - BioFire Quick Reference Guide
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Sample Management
UNIVERSAL - Sample Management Tracker, v7 10-Sep-2025
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Training
UNIVERSAL - AM11/12 Site Update, v1 23-Jul-2025
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Virus Positive Main Study - Other Patient Documents
UNIVERSAL - Witness Informed Consent Form (paper), v1 08-Apr-2022
UNIVERSAL - Patient Contact Details Proforma, v2 20-Mar-2023
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Virus Positive Main Study - Case Report Forms and Questionnaires
UNIVERSAL - Main - Case Report Form, v7 17-Jul-2025
UNIVERSAL -Updated Database and DQ Guidance, v1 04-Sep-2025
UNIVERSAL - Medication Log, v4 29-Jul-2025
UNIVERSAL - End of Study Case Report Form, v4 04-Jul-2022
UNIVERSAL - EQ-5D-5L Questionnaire, v4 24-Jun-2025
UNIVERSAL - FLU-PRO PLUS Questionnaire, v4 24-Jun-2025
UNIVERSAL - EQ-5D-5L & FLU-PRO PLUS Questionnaires Combined, v1 01-Sep-2025
UNIVERSAL - Post Viral Infection Questionnaires, v3 10-Feb-2025
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Virus Positive Main Study - PIS/ICF - England and Wales
UNIVERSAL - Main - Patient Information Sheet - E&W, v6 17-Jul-2025
UNIVERSAL - Main - Consultee Information Sheet - E&W, v6 17-Jul-2025
UNIVERSAL - Main - Informed Consent Form - E&W, v4 17-Jul-2025
UNIVERSAL - Main - Consultee Consent Form - E&W, v4 17-Jul-2025
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Virus Positive Main Study - PIS/ICF - England and Wales
UNIVERSAL - Main - Patient Information Sheet - Scotland, v3 17-Jul-2025
UNIVERSAL - Main - Recovered Patient Information Sheet - Scotland, v2 17-Jul-2025
UNIVERSAL - Main - Informed Consent Form - Scotland, v2 17-Jul-2025
UNIVERSAL - Main - Recovered Consent Form - Scotland, v2 17-Jul-2025
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Bortella Pertussis Pilot Study - PIS/ICF
UNIVERSAL - Main & BP - Patient Information Sheet, v2 17-Jul-2025
UNIVERSAL - Main & BP - Consultee Information Sheet, v2 17-Jul-2025
UNIVERSAL - Main & BP - Informed Consent Form, v2 17-Jul-2025
UNIVERSAL - Main & BP - Consultee Consent Form, v2 17-Jul-2025
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Bortella Pertussis Pilot Study - Case Report Forms and Questionnaires
UNIVERSAL - Bortella PertussisÌýCase Report Form, v2 17-Jul-2025
UNIVERSAL - Bortella PertussisÌýCase Report Form Stage 3, v1 17-Jul-2025
UNIVERSAL - Bortella Pertussis End of Study Case Report Form, v2 31-Jul-2024
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