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 treatment 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.
In set-up
Individuals admitted to hospital with a suspected respiratory viral infection.
This trial is funded by Janssen Pharmaceuticals with support in kind from Synairgen Ltd.
Senior Trial Manager:
Victoria Goss
Trial Manager:
Charlie Roberts
Data Manager:
Nicola Scott
Email: [email protected]
Email: [email protected]
Patient Documents
UNIVERSAL - Patient Information Sheet, v4 06-Dec-2022
UNIVERSAL - Consultee Information Sheet, v4 06-Dec-2022
UNIVERSAL - Informed Consent Form (paper), v2 10-Jun-2022
UNIVERSAL - Consultee Informed Consent Form (paper), v2 10-Jun-2022
UNIVERSAL - Witness Informed Consent Form (paper), v1 08-Apr-2022
UNIVERSAL - GP Letter, v1 08-Apr-2022
Study Documents
UNIVERSAL - Protocol, v4 06-Dec-2022
UNIVERSAL - Site Delegation Log, v2 06-Jul-2022
UNIVERSAL - Screening Log, v1 06-Jul-2022
UNIVERSAL - Laboratory Manual, v2 12-Aug-2022
UNIVERSAL - Medication Log, v2 01-Sep-2022
UNIVERSAL - Patient Contact Details Proforma, v1 17-Aug-2022
UNIVERSAL - Theory-Based Cover Letter (online), v1 09-Nov-2022
UNIVERSAL - Theory-Based Cover Letter (paper), v1 09-Nov-2022
UNIVERSAL - Participant Telephone Tex Email Reminder Guidance, v1 11-May-2022
Case Report Forms
UNIVERSAL - CRF, v4 07-Nov-2022
UNIVERSAL - EoS CRF, v4 04-Jul-2022
UNIVERSAL - EQ5D5L, v2 10-Oct-2022
UNIVERSAL - FLU PRO PLUS, v2 10-Oct-2022
UNIVERSAL - Post Viral Infection Questionnaire, v2 10-Oct-2022
UNIVERSAL - RiiQ English, v2 10-Oct-2022