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The University of Southampton
Southampton Clinical Trials Unit

UNIVERSAL

Title

Understanding Infection, Viral Exacerbation and Respiratory Symptoms at Admission- Longitudinal (UNIVERSAL) Study

Description

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.

Objectives

Primary:

  • To develop phenotypic characterisation of the heterogeneous nature of acute respiratory viral infection and recovery seen in patients admitted to hospital with respiratory symptoms.

Secondary:

  • To enable accurate stratification of patients for optimal design of future studies of novel pharmacological and non-pharmacological treatment strategies.
  • Health care Cost estimate for each patient.
  • To provide co-ordinated link to the central facility for sample storage.

Tertiary:

  • To enable a precision medicine strategy through detection of immune and inflammatory biomarkers associated with virus type and disease trajectory.

Trial Design

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.

Trial Status

In set-up

Population

Individuals admitted to hospital with a suspected respiratory viral infection.

Funder

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

 

Contact Information for trial queries

Email: universal@soton.ac.uk

 

SAE Reporting

Email: ctu@soton.ac.uk

 

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