Long-term follow up of adults hospitalised with COVID-19
| ISRCTN | ISRCTN10980107 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10980107 |
| IRAS number | 285439 |
| Secondary identifying numbers | CPMS 46443, IRAS 285439 |
- Submission date
- 16/07/2020
- Registration date
- 22/07/2020
- Last edited
- 27/01/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Infections and Infestations
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
Contact information
Scientific
NIHR Biomedical Research Centre- Respiratory
Department of Respiratory Sciences
University of Leicester
Glenfield Hospital
Groby Road
Leicester
LE3 9QP
United Kingdom
 ORCID ID |
0000-0002-9345-4903 |
|---|---|
| phosp@leicester.ac.uk |
Scientific
Department of Health Sciences
NIHR Biomedical Research Centre- Respiratory
University of Leicester
University Road
Leicester
LE1 7RH
United Kingdom
| ORCID ID |
0000-0003-4951-1867 |
|---|---|
| phosp@leicester.ac.uk |
Scientific
NIHR Biomedical Research Centre- Respiratory
Department of Respiratory Sciences
University of Leicester
Glenfield Hospital
Groby Road
Leicester
LE3 9QP
United Kingdom
| ORCID ID |
0000-0002-1667-868X |
|---|---|
| phosp@leicester.ac.uk |
Public
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 |
Study information
| Study design | Prospective observational longitudinal study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Longitudinal study |
| Study setting(s) | Hospital |
| Study type | Other |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | Post-hospitalisation COVID-19 study: a national consortium to understand and improve long-term health outcomes (PHOSP-COVID) |
| Study 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(s) | 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 |
| 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 |
| Primary outcome measure | Current primary outcome measure as of 18/11/2021: 1. Incidence of long-term sequelae of COVID-19 measured using multiple methods including: 1.1. Symptoms and quality of life measured using one or more of the following questionnaires: EQ-5D, Dyspnoea-12, Fatigue (FACIT), Brief Pain Inventory (BPI), MRC dyspnoea score, Montreal Cognitive Assessment (MoCA), Clinical Frailty Scale 1.2. 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) 1.3. Physical function measured using one or more the following tests: Short Physical Performance Battery (SPPB), Incremental Shuttle Walk Test (ISWT), muscle strength tests (handgrip strength), physical activity monitoring 1.4. Biological samples taken e.g blood, urine, sputum, saliva, breath 1.5. Any imaging as part of clinical care Measured at 6 weeks - 7.5 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) _____ Previous primary outcome measure: 1. Incidence of long-term sequelae of COVID-19 measured using multiple methods including: 1.1. 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 1.2. 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) 1.3. 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 1.4. Biological samples taken e.g blood, urine, sputum, saliva, breath 1.5. 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 | Current secondary outcome measures as of 18/11/2021: 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 - 7.5 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. _____ Previous 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 study start date | 15/04/2020 |
| Overall study end date | 31/12/2046 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 10000 |
| 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 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 | 01/03/2022 |
Locations
Countries of recruitment
- England
- Northern Ireland
- Scotland
- United Kingdom
- Wales
Study participating centres
University Hospitals of Birmingham NHS Trust
Mindelsohn Way
Edgbaston
Birmingham
B15 2TH
United Kingdom
Anlaby Rd
Hull
HU3 2JZ
United Kingdom
Duckworth Ln
Bradford
BD9 6RJ
United Kingdom
Southmead Rd
Bristol
BS10 5NB
United Kingdom
Elizabeth House
Cambridge
CB21 5EF
United Kingdom
Papworth Rd
Trumpington
Cambridge
CB2 0AY
United Kingdom
Great George St
Leeds
LS1 3EX
United Kingdom
Groby Road
Leicester
LE3 9QP
United Kingdom
Prescot St
Liverpool
L7 8XP
United Kingdom
The Bays
South Wharf Road
London
W2 1NY
United Kingdom
369 Fulham Rd
Chelsea
London
SW10 9NH
United Kingdom
Central Middlesex
Ealing Hospital
London
HA1 3UJ
United Kingdom
Rickmansworth Road
Northwood
London
HA6 2RN
United Kingdom
1 Manresa Rd
Chelsea
London
SW3 6LR
United Kingdom
Westminster Bridge Rd
London
SE1 7EH
United Kingdom
Denmark Hill
Brixton
London
SE5 9RS
United Kingdom
Whitechapel Rd
London
E1 1BB
United Kingdom
235 Euston Road
Bloomsbury
London
NW1 2BU
United Kingdom
Magdala Ave
London
N19 5NF
United Kingdom
17 Lyndhurst Gardens
Hampstead
London
NW3 5NU
United Kingdom
Sterling Way
London
N18 1QX
United Kingdom
Blackshaw Road
Tooting
London
SW17 0QT
United Kingdom
Cobbett House
Oxford Road
Manchester
M13 9WL
United Kingdom
Stott Ln
Salford
M6 8HD
United Kingdom
Freeman Road
High Heaton
Newcastle-upon-Tyne
NE7 7DN
United Kingdom
A Floor
Lisburn Road
Belfast
BT9 7AB
United Kingdom
Hucknall Road
Nottingham
NG5 1PB
United Kingdom
Headley Way
Headington
Oxford
OX3 9DU
United Kingdom
2 Eday Road
Aberdeen
AB15 6RE
United Kingdom
Moffat
DG10 9HL
United Kingdom
Dundee
DD2 1GZ
United Kingdom
Hayfield Rd
Kirkcaldy
KY2 5AH
United Kingdom
Larbert
FK5 4WR
United Kingdom
John Dewar Building
Highlander Way
Inverness
IV2 7GE
United Kingdom
Glasgow
G12 0XH
United Kingdom
Morningside Pl
Edinburgh
EH10 5HF
United Kingdom
Glossop Rd
Broomhall
Sheffield
S10 2JF
United Kingdom
Tremona Rd
Southampton
SO16 6YD
United Kingdom
St Davids Park
Jobswell Road
Carmarthen
SA31 3BB
United Kingdom
Baglan Energy Park
Baglan
Port Talbot
SA12 7BR
United Kingdom
Cardiff
CF14 4XW
United Kingdom
Newport
NP19 9PS
United Kingdom
Sarn Ln
Bodelwyddan
Rhyl
LL18 5UJ
United Kingdom
Glasgow
G75 8NH
United Kingdom
Sponsor information
University/education
University Road
Leicester
LE1 7RH
England
United Kingdom
| Phone | +44 (0)116 252 2522 |
|---|---|
| rgosponsor@leicester.ac.uk | |
| Website | https://le.ac.uk/about |
"ROR" |
https://ror.org/04h699437 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- UKRI
- Location
- United Kingdom
Government organisation / National government
- Alternative name(s)
- Medical Research Council (United Kingdom), UK Medical Research Council, MRC
- Location
- United Kingdom
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
Private sector organisation / Universities (academic only)
- Alternative name(s)
- UoL
- Location
- United Kingdom
Private sector organisation / Other non-profit organizations
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 31/01/2022 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| 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 plan | 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. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Interim results article | Two doses of SARS-CoV-2 vaccination induce robust immune responses to emerging SARS-CoV-2 variants of concern | 17/08/2021 | 19/08/2021 | Yes | No |
| Results article | 07/10/2021 | 11/10/2021 | Yes | No | |
| Interim results article | Symptom Persistence Despite Improvement in Cardiopulmonary Health - Insights from longitudinal CMR, CPET and lung function testing post-COVID-19 | 20/10/2021 | 26/10/2021 | Yes | No |
| Preprint results | preprint of clinical characteristics with inflammation profiling of Long-COVID and association with one-year recovery following hospitalisation in the UK | 15/12/2021 | 16/12/2021 | No | No |
| Results article | clinical characteristics with inflammation profiling of Long-COVID and association with one-year recovery following hospitalisation in the UK | 22/04/2022 | 27/04/2022 | Yes | No |
| Results article | prevalence of physical frailty, including risk factors, up to 1 year after hospitalisation for COVID-19 in the UK | 11/03/2023 | 21/03/2023 | Yes | No |
| HRA research summary | 26/07/2023 | No | No | ||
| Results article | Association of blood biomarkers with cognitive deficits | 31/08/2023 | 28/09/2023 | Yes | No |
| Results article | Long COVID and cardiovascular disease | 27/05/2024 | 28/05/2024 | Yes | No |
| Results article | Long term health outcomes in people with diabetes | 27/12/2024 | 27/01/2025 | Yes | No |
Editorial Notes
27/01/2025: Publication reference added.
28/05/2024: Publication reference added.
28/09/2023: Publication reference added.
27/04/2022: Publication reference added.
16/12/2021: Preprint reference added.
18/11/2021: The following changes were made to the trial record:
1. The primary outcome measure was changed.
2. The secondary outcome measures were changed.
26/10/2021: Publication reference added.
11/10/2021: Publication reference added.
19/08/2021: Publication reference added.
15/06/2021: The recruitment end date was changed from 01/05/2021 to 01/03/2022.
17/07/2020: Trial's existence confirmed by the NIHR.
