Condition category
Infections and Infestations
Date applied
16/07/2020
Date assigned
22/07/2020
Last edited
22/07/2020
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
COVID-19 is a condition caused by the coronavirus (called SARS-CoV-2) that was first identified in late 2019. This virus can infect the respiratory (breathing) system. Some people do not have symptoms but can carry the virus and pass it on to others. People who have developed the condition may develop a fever and/or a continuous cough among other symptoms. This can develop into pneumonia. Pneumonia is a chest infection where the small air pockets of the lungs, called alveoli, fill with liquid and make it more difficult to breathe.
In 2020, the virus has spread to many countries around the world and neither a vaccine against the virus or specific treatment for COVID-19 has yet been developed. As of April 2020, it is advised that people minimize travel and social contact, and regularly wash their hands to reduce the spread of the virus.
Groups who are at a higher risk from infection with the virus, and therefore of developing COVID-19, include people aged over 70 years, people who have long-term health conditions (such as asthma or diabetes), people who have a weakened immune system and people who are pregnant. People in these groups, and people who might come into contact with them, can reduce this risk by following the up-to-date advice to reduce the spread of the virus.
The COVID-19 pandemic has tragically led to severe acute illness, hospitalisation and death. Beyond the health of those affected, it has had widespread economic, psychological and societal effects. The clinical spectrum is broad, ranging from those with no or minimal symptoms to severe pneumonia in 15-20% with evidence of widespread disease beyond the lung. As we emerge from the first wave of the pandemic we have new insights into the acute phase of this disease but very little information concerning the long-term effects of COVID-19 and the ongoing medical, psychological and rehabilitation needs of these patients. This will be a national UK research study, embedded within clinical care, that aims to understand and improve long-term outcomes for survivors following hospitalisation with COVID-19. This study includes expert groups across the UK and will use standardised assessments of patients, including advanced imaging, recording of information and collection of samples. This study will provide researchers with a comprehensive understanding of the impact on the health of those that have been hospitalised with COVID-19. This will enable trials of new strategies of clinical care including personalised treatments to improve the long-term outcome of current and future COVID-19 survivors.

Who can participate?
Patients aged over 18 who were admitted to a UK hospital and discharged following suspected COVID-19

What does the study involve?
The researchers will collect data from any clinic visits and from routine health records of all participants. This will include signs and symptoms, medication, physical test results, questionnaire answers, laboratory test results and imaging. In a subset of participants, the researchers will undertake additional research tests and obtain samples (for example, blood) for research experiments. Some participants may be asked to take part in additional studies.

What are the possible benefits and risks of participating?
There is no direct benefit to participants as this study will not directly change the clinical care that they receive. The information that is collected may help clinicians to better care for other patients in the future. If there are any test results that require follow-up, the participants’ doctor will be informed. The researchers will not share the results from unvalidated research tests using the samples (for example, genetic data). Some participants may be asked to provide additional samples in addition to those needed for their clinical care. Whenever possible these samples will be taken at the same time as regular samples to reduce the extra procedures and participants will be advised on the maximum amount of sample that we will take when they agree to take part (and they will be free to decline any extra tests or samples). There is a risk of pain or discomfort when samples are taken, and these are detailed in the participant information sheet.

Where is the study run from?
The study is led by the University of Leicester and participants will be recruited at multiple hospital sites from across the UK (including Scotland, Wales and Northern Ireland)

When is the study starting and how long is it expected to run for?
April 2020 to December 2046

Who is funding the study?
This study is supported by a grant to the University of Leicester from the MRC-UK Research and Innovation, and National Institute for Health Research (NIHR) rapid response panel to tackle COVID-19 and by core funding provided by NIHR Leicester Biomedical Research Centre - a partnership between the University of Leicester and University Hospitals of Leicester NHS Trust.

Who is the main contact?
Prof. Chris Brightling
phosp@leicester.ac.uk

Trial website

https://www.phosp.org/

Contact information

Type

Scientific

Primary contact

Prof Christopher Brightling

ORCID ID

http://orcid.org/0000-0002-9345-4903

Contact details

NIHR Biomedical Research Centre- Respiratory
Department of Respiratory Sciences
University of Leicester
Glenfield Hospital
Groby Road
Leicester
LE3 9QP
United Kingdom
-
phosp@leicester.ac.uk

Type

Scientific

Additional contact

Prof Louise Wain

ORCID ID

http://orcid.org/0000-0003-4951-1867

Contact details

Department of Health Sciences
NIHR Biomedical Research Centre- Respiratory
University of Leicester
University Road
Leicester
LE1 7RH
United Kingdom
-
phosp@leicester.ac.uk

Type

Scientific

Additional contact

Dr Rachael Evans

ORCID ID

http://orcid.org/0000-0002-1667-868X

Contact details

NIHR Biomedical Research Centre- Respiratory
Department of Respiratory Sciences
University of Leicester
Glenfield Hospital
Groby Road
Leicester
LE3 9QP
United Kingdom
-
phosp@leicester.ac.uk

Type

Public

Additional contact

Miss Ananga Sundari Devi Dasi

ORCID ID

Contact details

NIHR Biomedical Research Centre- Respiratory
Department of Respiratory Sciences
College of Life Sciences
Glenfield Hospital
Groby Road
Leicester
LE3 9QP
United Kingdom
-
phosp@leicester.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

CPMS 46443, IRAS 285439

Study information

Scientific title

Post-hospitalisation COVID-19 study: a national consortium to understand and improve long-term health outcomes (PHOSP-COVID)

Acronym

PHOSP-COVID

Study hypothesis

The aims of this study are to:
1. Determine the short to long-term chronic health (and health economic) sequelae of COVID-19 infection in post-hospitalisation survivors; to define demographic, clinical and molecular biomarkers of the susceptibility, development, progression and resolution of these health sequelae
2. Understand the impact of interventions during the acute illness on these long-term sequelae
3. Build the foundation for multiple in-depth studies e.g. lung fibrosis, pulmonary and systemic vasculature, cardiometabolic, renal, sarcopenia, rehabilitation, mental health and neurological disease.
The findings will inform precision medicine in at-risk groups by directing new clinical trials and care for current and future post-COVID-19 patients.

Ethics approval

Approved 14/07/2020, Yorkshire & The Humber -Leeds West Research Ethics Committee (NHSBT Newcastle Blood Donor Centre, Holland Drive, Newcastle upon Tyne, NE2 4NQ, UK; +44 (0)207 972 2504, +44 (0)207 104 8088, +44 (0)207 104 8018; leedswest.rec@hra.nhs.uk), REC ref: 20/YH/0225

Study design

Prospective observational longitudinal study

Primary study design

Observational

Secondary study design

Longitudinal study

Trial setting

Hospitals

Trial type

Other

Patient information sheet

Not available in web format, please use the contact details to request a participant information sheet

Condition

Adult survivors of a hospital admission with COVID-19 (SARS-CoV-2 infection)

Intervention

PHOSP-COVID is an observational longitudinal follow-up study of adults post-hospitalisation with COVID-19. The researchers propose to analyse routine clinical data with linkage to retrospective and prospective health and social care records (Tier 1), enhanced clinical data and research-specific biosampling (Tier 2) and re-call of participants by genotype and phenotype for more detailed studies (Tier 3).

All participants will be followed up for at least 12 months after discharge from hospital. The researchers will ask participants for their agreement to continue to extract data from their electronic records, and to be contacted about future research, for at least 25 years after recruitment to the study.

Intervention type

Other

Phase

Drug names

Primary outcome measure

1. Incidence of long-term sequelae of COVID-19 measured using multiple methods including:
1. Symptoms and quality of life measured using one or more of the following questionnaires: EQ-5D, Sarcopenia screen (SARC-F), General Practice Physical Activity Questionnaire (GPPAQ), Dyspnoea-12, Fatigue (FACIT), Brief Pain Inventory (BPI), Nottingham extended activity of daily living (NEADL), MRC dyspnoea score, Montreal Cognitive Assessment (MoCA), Clinical Frailty Scale, Fried Frailty assessment
2. Mental health: symptoms of anxiety assessed using Generalised Anxiety Disorder Assessment (GAD-7), depression assessed using Patient Health Questionnaire (PHQ-9), post-traumatic stress disorder (PTSD) checklist (PCL-5)
3. Physical function measured using one or more the following tests: Short Physical Performance Battery (SPPB), Incremental Shuttle Walk Test (ISWT), muscle strength tests (handgrip and quadriceps strength), physical activity monitoring, cardiometabolic risk assessment and body composition measurements
4. Biological samples taken e.g blood, urine, sputum, saliva, breath
5. Any imaging as part of clinical care
Measured at 6 weeks, 3 months, 6 months and 12 months post-hospital discharge (and at regular timepoints thereafter for up to 25 years)
Please note that not all participants will be asked to complete or perform all of the above questionnaires and tests. Data from routine clinical investigations and tests will be recorded.
2. Healthcare utilisation measured using questionnaires and linkage to health and social care records at 6 weeks, 3 months, 6 months and 12 months post-hospital discharge (and at regular timepoints thereafter for up to 25 years)
3. Mortality measured using ONS data at 6 weeks, 3 months, 6 months and 12 months post-hospital discharge (and at regular timepoints thereafter for up to 25 years)

Secondary outcome measures

Characterisation of specific long-term morbidities and impacts of COVID-19 hospitalisation measured using multiple methods including:
1. Symptoms and quality of life measured using one or more of the following questionnaires: EQ-5D, Sarcopenia screen (SARC-F), General Practice Physical Activity Questionnaire (GPPAQ), Dyspnoea-12, Fatigue (FACIT), Brief Pain Inventory (BPI), Nottingham extended activity of daily living (NEADL), MRC dyspnoea score, Montreal Cognitive Assessment (MoCA), Clinical Frailty Scale, Fried Frailty assessment
2. Mental health: symptoms of anxiety assessed using Generalised Anxiety Disorder Assessment (GAD-7), depression assessed using Patient Health Questionnaire (PHQ-9), post-traumatic stress disorder (PTSD) checklist (PCL-5)
3. Physical function measured using one or more the following tests: Short Physical Performance Battery (SPPB), Incremental Shuttle Walk Test (ISWT), muscle strength tests (handgrip and quadriceps strength), physical activity monitoring, cardiometabolic risk assessment and body composition measurements
4. Biological samples taken e.g blood, urine, sputum, saliva, breath
5. Any imaging as part of clinical care
6. Healthcare utilisation assessed from linkage to health and social care records
Measured at 6 weeks, 3 months, 6 months and 12 months post-hospital discharge (and at regular timepoints thereafter for up to 25 years)

Please note that not all participants will be asked to complete or perform all of the above questionnaires and tests. Data from routine clinical investigations and tests will be recorded.

Overall trial start date

15/04/2020

Overall trial end date

31/12/2046

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Participant admitted to an acute admissions unit or ward at a UK hospital and discharged with suspected COVID-19
2. Age 18 years and over
3. Participant is willing and able to give informed consent for participation in the study
4. Aged 18 years or above

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

10000

Participant exclusion criteria

1. Confirmed diagnosis of a pathogen unrelated to the objectives of this study and no indication or likelihood of co-infection with a relevant pathogen
2. Attendance at an A&E or emergency department only
3. Refusal by participant, parent or appropriate representative
4. Other life-limiting illness with life expectancy <6 months such as disseminated malignancy

Recruitment start date

25/07/2020

Recruitment end date

01/05/2021

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Queen Elizabeth Hospital
Heritage Building University Hospitals of Birmingham NHS Trust Mindelsohn Way Edgbaston
Birmingham
B15 2TH
United Kingdom

Trial participating centre

Hull Royal Infirmary
Hull University Teaching Hospitals NHS Trust Anlaby Rd
Hull
HU3 2JZ
United Kingdom

Trial participating centre

Bradford Royal Infirmary
Bradford Teaching Hospitals NHS Foundation Trust Duckworth Ln
Bradford
BD9 6RJ
United Kingdom

Trial participating centre

Southmead Hospital
North Bristol NHS Trust Southmead Rd
Bristol
BS10 5NB
United Kingdom

Trial participating centre

Fulbourn Hospital
Cambridgeshire and Peterborough NHS Foundation Trust Elizabeth House
Cambridge
CB21 5EF
United Kingdom

Trial participating centre

Royal Papworth Hospital
Royal Papworth Hospital NHS Foundation Trust Papworth Rd Trumpington
Cambridge
CB2 0AY
United Kingdom

Trial participating centre

Leeds General Infirmary
The Leeds Teaching Hospitals NHS Trust Great George St
Leeds
LS1 3EX
United Kingdom

Trial participating centre

Glenfield Hospital
University Hospitals of Leicester NHS Trust Groby Road
Leicester
LE3 9QP
United Kingdom

Trial participating centre

Royal Liverpool Hospital
Liverpool University Hospitals NHS Foundation Trust Prescot St
Liverpool
L7 8XP
United Kingdom

Trial participating centre

St Mary's Hospital
Imperial College Healthcare NHS Trust The Bays South Wharf Road
London
W2 1NY
United Kingdom

Trial participating centre

Chelsea & Westminster Hospital
Chelsea & Westminster Hospital NHS Trust 369 Fulham Rd Chelsea
London
SW10 9NH
United Kingdom

Trial participating centre

Northwick Park Hospital
London North West University Healthcare NHS Trust Central Middlesex Ealing Hospital
London
HA1 3UJ
United Kingdom

Trial participating centre

Mount Vernon Hospital
The Hillingdon Hospitals NHS Foundation Trust Rickmansworth Road Northwood
London
HA6 2RN
United Kingdom

Trial participating centre

Royal Brompton & Harefield Trust
Royal Brompton Hospital 1 Manresa Rd Chelsea
London
SW3 6LR
United Kingdom

Trial participating centre

St Thomas' Hospital
Guy's and St Thomas' NHS Foundation Trust Westminster Bridge Rd
London
SE1 7EH
United Kingdom

Trial participating centre

King's College Hospital
King's College Hospital NHS Foundation Trust Denmark Hill Brixton
London
SE5 9RS
United Kingdom

Trial participating centre

The Royal Hospital
Barts Health NHS Trust Whitechapel Rd
London
E1 1BB
United Kingdom

Trial participating centre

University College London Hospital
University College London Hospitals NHS Foundation Trust 235 Euston Road Bloomsbury
London
NW1 2BU
United Kingdom

Trial participating centre

The Whittington Hospital
Whittington Health NHS Trust Magdala Ave
London
N19 5NF
United Kingdom

Trial participating centre

Royal Free Hospital
Royal Free London NHS Foundation Trust 17 Lyndhurst Gardens Hampstead
London
NW3 5NU
United Kingdom

Trial participating centre

North Middlesex University Hospital
North Middlesex University Hospital NHS Trust Sterling Way
London
N18 1QX
United Kingdom

Trial participating centre

St George's Hospital
St George's University Hospitals NHS Foundation Trust Blackshaw Road Tooting
London
SW17 0QT
United Kingdom

Trial participating centre

Manchester Royal Infirmary
Manchester University NHS Foundation Trust Cobbett House Oxford Road
Manchester
M13 9WL
United Kingdom

Trial participating centre

Salford Royal Hospital
Salford Royal NHS Foundation Trust Stott Ln
Salford
M6 8HD
United Kingdom

Trial participating centre

Freeman Hospital
Newcastle Upon Tyne Hospitals NHS Foundation Trust Freeman Road High Heaton
Newcastle-upon-Tyne
NE7 7DN
United Kingdom

Trial participating centre

Belfast City Hospital
Belfast Health and Social Care Trust A Floor Lisburn Road
Belfast
BT9 7AB
United Kingdom

Trial participating centre

Nottingham City Hospital
Nottingham University Hospitals NHS Trust Hucknall Road
Nottingham
NG5 1PB
United Kingdom

Trial participating centre

John Radcliffe Hospital
Oxford University Hospitals NHS Foundation Trust Headley Way Headington
Oxford
OX3 9DU
United Kingdom

Trial participating centre

NHS Grampian
Summerfield House 2 Eday Road
Aberdeen
AB15 6RE
United Kingdom

Trial participating centre

NHS Dumfries and Galloway
21-22 High St
Moffat
DG10 9HL
United Kingdom

Trial participating centre

NHS Tayside
230 Clepington Rd
Dundee
DD2 1GZ
United Kingdom

Trial participating centre

NHS Fife
Hayfield House Hayfield Rd
Kirkcaldy
KY2 5AH
United Kingdom

Trial participating centre

NHS Forth Valley
Stirling Rd
Larbert
FK5 4WR
United Kingdom

Trial participating centre

NHS Highland
Inverness Retail and Business Park John Dewar Building Highlander Way
Inverness
IV2 7GE
United Kingdom

Trial participating centre

NHS Greater Glasgow and Clyde
1055 Great Western Road
Glasgow
G12 0XH
United Kingdom

Trial participating centre

NHS Lothian
Search Results Morningside Pl
Edinburgh
EH10 5HF
United Kingdom

Trial participating centre

Royal Hallamshire Hospital
Sheffield Teaching Hospitals NHS Foundation Trust Glossop Rd Broomhall
Sheffield
S10 2JF
United Kingdom

Trial participating centre

Southampton General Hospital,
University Hospital Southampton NHS Foundation Trust Tremona Rd
Southampton
SO16 6YD
United Kingdom

Trial participating centre

Hywel Dda University Health Board
Ystwyth Building St Davids Park Jobswell Road
Carmarthen
SA31 3BB
United Kingdom

Trial participating centre

Swansea Bay University Health Board
1 Talbot Gateway Baglan Energy Park Baglan
Port Talbot
SA12 7BR
United Kingdom

Trial participating centre

Cardiff & Vale University Health Board
Heath Park
Cardiff
CF14 4XW
United Kingdom

Trial participating centre

Aneurin Bevan University Health Board
Ringland Circle
Newport
NP19 9PS
United Kingdom

Trial participating centre

Betsi Cadwaladr University Health Board
Glan Clwyd Hospital Sarn Ln Bodelwyddan
Rhyl
LL18 5UJ
United Kingdom

Trial participating centre

Lanarkshire Primary Care NHS Trust
East Kilbride
Glasgow
G75 8NH
United Kingdom

Sponsor information

Organisation

University of Leicester

Sponsor details

University Road
Leicester
LE1 7RH
United Kingdom
+44 (0)116 252 2522
rgosponsor@leicester.ac.uk

Sponsor type

University/education

Website

https://le.ac.uk/about

Funders

Funder type

Government

Funder name

UK Research and Innovation

Alternative name(s)

UKRI

Funding Body Type

private sector organisation

Funding Body Subtype

Other non-profit organizations

Location

United Kingdom

Funder name

Medical Research Council

Alternative name(s)

MRC

Funding Body Type

government organisation

Funding Body Subtype

National government

Location

United Kingdom

Funder name

National Institute for Health Research

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

National government

Location

United Kingdom

Funder name

University of Leicester

Alternative name(s)

UoL

Funding Body Type

private sector organisation

Funding Body Subtype

Universities (academic only)

Location

United Kingdom

Funder name

University Hospitals of Leicester NHS Trust

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

Other non-profit organizations

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Results of the study will be made available in a timely fashion and published in a high-impact peer-reviewed journal.

IPD sharing statement
Participant-level data will be made available for bona fide researchers via application. Researchers interested in accessing the data should contact phosp@leicester.ac.uk or visit http://www.phosp.org for more details of the process and an application form. Access to data and materials and the study are reviewed and approved by an independent data and materials access committee. Participants have provided appropriate consent to share their anonymised (pseudonymised) data. All access to data will be subject to agreement to appropriate terms and conditions.

Intention to publish date

31/01/2022

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

17/07/2020: Trial's existence confirmed by the NIHR.