Understanding viral infection and respiratory symptoms following admission to hospital
| ISRCTN | ISRCTN49183956 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN49183956 |
| IRAS number | 309464 |
| Secondary identifying numbers | IRAS 309464, CPMS 53752 |
- Submission date
- 01/06/2022
- Registration date
- 09/08/2022
- Last edited
- 23/04/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Infections and Infestations
Plain English Summary
Background and study aims
The majority of winter pressures facing NHS hospital trusts are as a result of acute respiratory viral infections. Whilst many patients recover without the need for hospitalisation, a small number go on to develop severe disease. This study aims to better understand the different responses between individuals to respiratory viral infections, and why some patients become more unwell than others. The researchers hope to identify new ways to spot respiratory diseases. The aim is to understand the time to full recovery and identify factors that favour a more rapid recovery or predispose to a slower recovery.
Who can participate?
Patients aged 18 years and over who present in a hospital setting with a suspected respiratory viral infection
What does the study involve?
A nose and throat swab will be collected, and a point of care to test to determine if the participant has a respiratory viral infection will be carried out. Only those who test positive for a respiratory viral infection will go on to stage 2 of the study, although all participants who consent will have baseline data recorded. In stage 2, further nose and throat swabs and blood samples will be collected on days 1, 3 and 7 of enrolment. As well as completing questionnaires about how they are feeling while in hospital, participants will complete questionnaires following discharge from hospital at pre-specified time points up to 26 weeks later.
What are the possible benefits and risks of participating?
This study is an observational study, so participants will receive no treatment different from standard of care, but the study will help researchers to better understand the course of respiratory viral infections. This may help aid the treatment of patients in the future as well as the development of new treatments. The risks of this study are no greater than that of standard care. Nose/throat swabs might cause some mild discomfort, and the taking of blood may cause bruising around the area, light pain or dizziness. All procedures as part of the study are carried out by trained healthcare professionals.
When is the study starting and how long is it expected to run for?
November 2021 to February 2026
Where is the study run from?
Southampton General Hospital (UK)
Who is funding the study?
1. Janssen Pharmaceuticals (USA)
2. AstraZeneca (UK)
Who is the main contact?
UNIVERSAL Study Team
UNIVERSAL@soton.ac.uk
Contact information
Principal Investigator
Mailpoint 810, Level F, South Block
Southampton General Hospital
Southampton
SO16 6YD
United Kingdom
| Phone | +44 (0)2381205341 |
|---|---|
| t.wilkinson@soton.ac.uk |
Study information
| Study design | Prospective longitudinal observational database |
|---|---|
| Primary study design | Observational |
| Secondary study design | Longitudinal study |
| Study setting(s) | Hospital |
| Study type | Quality of life |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Understanding Infection, Viral Exacerbation and Respiratory Symptoms at Admission - Longitudinal (UNIVERSAL) study |
| Study acronym | UNIVERSAL |
| Study hypothesis | The recent COVID-19 pandemic highlighted the need to link clinical care with research for a 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. Whilst many patients recover without the need for hospitalisation, a small proportion goes on to develop severe disease. 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. |
| Ethics approval(s) | Approved 01/07/2022, West Midlands – Coventry and Warwickshire Research Ethics Committee (The Old Chapel, Royal Standard Place, Nottingham, NG1 6FS, UK; +44 (0)207 104 8009; coventryandwarwick.rec@hra.nhs.uk), ref: 22/WM/0119 |
| Condition | Respiratory viral infections |
| Intervention | This is an observational cohort study to develop a prospective longitudinal clinical database. All adults admitted with respiratory syndromes to participating hospital sites will be asked to participate in the study. Those who test positive for respiratory viral infection will be enrolled into the study and provide samples. Those who consent and test negative will have baseline data collection only. Those who test positive will give blood samples and nose and throat samples on days 1, 3 and 7 following consent. They will also complete a number of different patient-reported outcome questionnaires (EQ-5D-5L, RiiQ, FluPRO PLUS) at a number of timepoints until 26 weeks post-enrolment. They will also complete a post-viral infection questionnaire at 6, 12 and 26 weeks comprised of three validated questionnaires. |
| Intervention type | Other |
| Primary outcome measure | 1. The incidence rate of different respiratory viruses in admitted, samples patient population measured using descriptive statistics during the winter season (a 1-year period) across UK sites 2. Clinical and biological predictors of progression of disease, recovery and length of stay in admitted, samples patient population measured using multiple logistic regression analysis with backward selection during the winter season (a 1-year period) across UK sites |
| Secondary outcome measures | 1. Time to recovery for different viruses and patient factors measured using univariate analyses at baseline/recovery 2. Cost estimate per patient based on Healthcare Resource Group (HRG) coding at baseline/discharge |
| Overall study start date | 01/11/2021 |
| Overall study end date | 17/02/2026 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 2000 consented, 1000 positive for a respiratory viral infection |
| Participant inclusion criteria | Current inclusion criteria as of 09/09/2022: Stage 1 1. Aged ≥18 years 2. Has symptoms of an acute respiratory illness (ARI) 3. Is a respiratory inpatient Plus, for Stage 2 3. Has positive test result for respiratory viral infection _____ Previous inclusion criteria: Stage 1 1. Aged ≥18 years old 2. Has symptoms of an acute respiratory illness (ARI)* Plus, for Stage 2 3. Has positive test result for respiratory viral infection |
| Participant exclusion criteria | 1. Combined nasal and throat swabbing cannot be performed (patient decision or contraindication to procedure) 2. Consent declined or consultee consent declined 3. Previously recruited into this study |
| Recruitment start date | 17/06/2022 |
| Recruitment end date | 31/12/2025 |
Locations
Countries of recruitment
- England
- Scotland
- United Kingdom
Study participating centres
Southampton
SO16 6YD
United Kingdom
Dundee
DD1 9SY
United Kingdom
Sponsor information
Hospital/treatment centre
Southampton General Hospital
Tremona Road
Southampton
SO16 6YD
England
United Kingdom
| Phone | +44 (0)2381205662 |
|---|---|
| Sharon.davies-dear@uhs.nhs.uk | |
| Website | http://www.uhs.nhs.uk/home.aspx |
"ROR" |
https://ror.org/0485axj58 |
Funders
Funder type
Industry
Private sector organisation / For-profit companies (industry)
- Alternative name(s)
- Janssen Pharmaceutica NV, JANSSEN-CILAG NV, Janssen Belgium, Janssen, Janssen Pharmaceuticals
- Location
- Belgium
Government organisation / For-profit companies (industry)
- Alternative name(s)
- AstraZeneca PLC, Pearl Therapeutics
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 01/06/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be available upon request. As a minimum, anonymous data will be available for request from 3 months after the publication of an article, to researchers who provide a completed Data Sharing request form that describes a methodologically sound proposal, for the purpose of the approved proposal and if appropriate a signed Data Sharing Agreement. Data will be shared once all parties have signed relevant data sharing documentation. Researchers interested in our data are asked to complete the Request for Data Sharing form (CTU/FORM/5219) [template located on the SCTU website, https://www.southampton.ac.uk/ctu] to provide a brief research proposal on how they wish to use the data. It will include; the objectives, what data are requested, timelines for use, intellectual property and publication rights, data release definition in the contract and participant informed consent etc. If considered necessary, a Data Sharing Agreement from Sponsor may be required. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No | ||
| Protocol article | 09/04/2025 | 23/04/2025 | Yes | No |
Editorial Notes
23/04/2025: Publication reference added.
04/12/2024: The following changes were made:
1. The overall study end date was changed from 17/02/2025 to 17/02/2026.
2. The recruitment end date was changed from 31/12/2024 to 31/12/2025.
3. The intention to publish date was changed from 01/06/2025 to 01/06/2026.
27/02/2024: The recruitment end date has been changed from 30/11/2023 to 31/12/2024.
14/11/2023: The overall end date was changed from 17/06/2024 to 17/02/2025.
05/12/2022: The recruitment end date has been changed from 30/08/2023 to 30/11/2023.
02/12/2022: The sponsor email was changed.
09/09/2022: The following changes have been made:
1. The ethics approval has been added.
2. The trial website has been added.
3. The participant inclusion criteria have been changed.
4. The recruitment end date has been changed from 30/06/2023 to 30/08/2023.
05/09/2022: Internal review.
15/06/2022: Trial's existence confirmed by the Coventry and Warwick Research Ethics Committee.
