Understanding infection viral exacerbation and respiratory symptoms at admission-longitudinal (UNIVERSAL) study: a prospective observational cohort study protocol

Abstract

Background: respiratory viral infections (RVIs) are a significant cause of morbidity and hospital admission worldwide. However, the management of most viral infection-associated diseases remains primarily supportive. The recent COVID-19 pandemic has underscored the urgent need for a deeper understanding of RVIs to improve patient outcomes and develop effective treatment strategies. The UNIVERSAL Study is an observational study which addresses this need by investigating the heterogeneity of RVIs in hospitalised adults, aiming to identify clinical and biological predictors of adverse outcomes. This study aims to bridge critical knowledge gaps in the clinical course and the economic impact of RVIs by characterising the phenotypic diversity of these infections and their recovery patterns following hospital admission and thus assisting with the optimal design of future interventional studies.

Methods and analysis: this prospective longitudinal observational study, (Version 6, 20th September 2023), will be conducted across multiple UK secondary care sites from August 2022 onwards, with an aim to enrol 1000 participants testing positive for RVI. Adults admitted with respiratory symptoms who test positive for RVIs via the BioFire® FilmArray® System or other validated diagnostic polymerase chain reaction (PCR) tests will be enrolled. The data collected includes patient demographics, clinical history, comorbidities, and symptoms experienced prior to, during and after hospitalisation with follow-up after discharge at weeks 1, 2, 4, 8, 12, and 26. In addition, biological samples are collected at multiple time points during the hospital stay. The primary endpoints are to study the impact of different RVIs and identify predictors of disease progression and length of stay. Secondary endpoints include time to recovery and healthcare cost estimates. Exploratory endpoints focus on biomarker profiles associated with virus type and clinical outcomes.

Ethics and dissemination: the study protocol received ethical approval from the relevant committees (English Ethics Reference Number: 22/WM/0119; Scottish Ethics Reference Number: 22-SS-0101, 20/09/2023). For patients who lack the capacity to consent, the study complies with the Mental Capacity Act 2005, using a consultee process where a family member, carer or an independent clinician may provide assent on behalf of the patient. Data from all the study centres will be analysed together and disseminated through peer-reviewed journals, conference presentations and workshops. The study group will ensure that participants and their families are informed of the study findings promptly and in an accessible format.

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Identifiers

ORCID for Tommaso Geraldo Morelli: orcid.org/0009-0008-7151-171X

ORCID for Charlie Roberts: orcid.org/0009-0002-6654-0918

ORCID for Paul Lee: orcid.org/0000-0002-5729-6450

ORCID for Gareth Griffiths: orcid.org/0000-0002-9579-8021

ORCID for Andrew Cook: orcid.org/0000-0002-6680-439X

ORCID for Karl J. Staples: orcid.org/0000-0003-3844-6457

ORCID for Tristan Clark: orcid.org/0000-0001-6026-5295

ORCID for Anna Freeman: orcid.org/0000-0003-3495-2520

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