A long-term observational study of people who have had coronavirus disease (COVID-19) in Scotland
| ISRCTN | ISRCTN76339681 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN76339681 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Integrated Research Application System (IRAS) | 284116 |
| Protocol serial number | IRAS 284116 |
| Sponsor | NHS Tayside |
| Funders | Chief Scientist Office, Scottish Government Health and Social Care Directorate, British Lung Foundation |
- Submission date
- 22/10/2020
- Registration date
- 05/03/2021
- Last edited
- 06/04/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Infections and Infestations
Plain English summary of protocol
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.
Severe COVID-19 infection can cause severe pneumonia and acute respiratory distress syndrome (ARDS) leading to a requirement for mechanical ventilation. It is also now recognised that it can cause inflammation of blood vessels which may lead to a longer term increased risk of cardiovascular disease. NHS Scotland must plan for the long term care of potentially thousands of patients who will experience long term complications of COVID-19, both within the lung and outside the lung. As COVID19 is a new disease, there is a need to identify the long term consequences and future care needs of COVID19 survivors.
Who can participate?
We wish to establish a national cohort of 300 people over the age of 18 years who have had COVID19, either as hospital inpatients or in the community.
What does the study involve?
In this study, blood testing, urine, respiratory samples, and tests of blood vessel function will be used to help determine the long term consequences of this disease and identify future management approaches. This will be through the current study and in the future with analysis of healthcare use.
Specific interests will include the recovering epithelial function in the lungs; endothelial function relating to cardiovascular disease and diabetes; effects of COVID-19 on complications related to, and management of diabetes; characterising the microbiome of the airway epithelium after COVID-19; development of a biobank of samples to further research predictors of long term health outcomes; long term assessment of healthcare use following COVID disease.
What are the possible benefits and risks of taking part?
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 participant and their doctor will be informed.
Whenever possible any study samples will be taken at the same time as regular samples to reduce the extra procedures. There is a risk of discomfort when samples are taken, and this is detailed in the participant information sheet.
Where is the study run from?
From NHS Tayside (UK) and will recruit participants from multiple sites across Scotland.
When is the study starting and how long is it expected to run?
From June 2020 to December 2046.
Who is funding the study?
The study is funded by Chief Scientist Office, Scottish Government (UK) and the British Lung Foundation (UK)
Who is the main contact?
Dr David Connell, Chief Investigator
david.connell@nhs.scot
Contact information
Public
Department of Population Health and Genomics
School of Medicine
University of Dundee
Dundee
DD1 9SY
United Kingdom
 ORCID ID |
0000-0002-7008-8883 |
|---|---|
| Phone | +44 (0)1382 385968 |
| s.gallant@dundee.ac.uk |
Scientific
Department of Respiratory Medicine
NHS Tayside
Ninewells Hospital and Medical School
Dundee
DD1 9SY
United Kingdom
| Phone | +44 (0)1382 660111 |
|---|---|
| david.connell@nhs.scot |
Study information
| Primary study design | Observational |
|---|---|
| Study design | Multi-centre prospective observational longitudinal study |
| Secondary study design | Longitudinal study |
| Study type | Participant information sheet |
| Scientific title | FOcused LongitudinaL Observational study to improve knoWledge of COVID-19 (FOLLOW-COVID) |
| Study acronym | FOLLOW-COVID |
| Study objectives | 1. To describe the consequences of COVID-19, on the airway epithelial microbiome, and on longitudinal lung epithelial and vascular function, in a cohort of patients who have had a spectrum of disease as a result of infection with SARS-CoV-2 2. To describe neutrophil function in survivors of severe COVID-19 pneumonia 3. To generate a biobank of samples from patients who are recovering from COVID-19, which can later be used to identify and predict recovery from severe COVID-19 across a range of health domains, including diabetes 4. To determine long term healthcare resource utilisation in patients who have had COVID-19 disease |
| Ethics approval(s) | Approved 16/09/2020, Yorkshire and The Humber - South Yorkshire Research Ethics Committee (NHSBT Newcastle Blood Donor Centre, Holland Drive, Newcastle, HE2 4NQ, UK: +44 (0)207 1048091; southyorks.rec@hra.nhs.uk), ref 20/YH/0265 |
| Health condition(s) or problem(s) studied | COVID-19 (SARS-CoV-2 infection) |
| Intervention | FOLLOW-COVID is an observational longitudinal follow-up study of adults with COVID-19. The researchers propose to analyse routine clinical data with linkage to retrospective and prospective health and social care records with research-specific biosampling. All participants will be seen at two study visits, 3-6 months post-COVID-19 infection, at which samples will be obtained, then followed up by telephone at years 1, 2, and 5. 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 up to 25 years after recruitment to the study. |
| Intervention type | Other |
| Primary outcome measure(s) |
1. A description of the early longitudinal changes in the airway epithelial microbiome and mycobiome using radiological and clinical note review at 3-6 months post-COVID-19 |
| Key secondary outcome measure(s) |
1. A detailed description of the early (3-6 months) regenerating ultrastructural changes in the nasal airway epithelium measured using a combination of video microscopy, electron microscopy, and cell culture techniques, in a spectrum of patients recovering from COVID-19 at 3-6 months post-COVID-19 |
| Completion date | 31/12/2046 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 300 |
| Key inclusion criteria | 1. Previous clinical (only if hospitalised) or microbiological (if hospitalised or non-hospitalised) diagnosis of COVID-19 disease 2. Aged >18 years |
| Key exclusion criteria | 1. Unable to give informed consent 2. Participation is not in the interests of the patient as determined by the investigator (e.g. palliative care) 3. If an individual has any symptoms compatible with current COVID-19 (as per the Health Protection Scotland Guidelines relevant at that time) 4. Currently isolated following a contact with COVID-19 5. Has had an upper respiratory tract infection in the preceding 14 days 6. Nasal brushings only: Patient has a history of significant epistaxis or is anti-coagulated |
| Date of first enrolment | 13/10/2020 |
| Date of final enrolment | 31/01/2021 |
Locations
Countries of recruitment
- United Kingdom
- Scotland
Study participating centres
Clepington Road
Dundee
DD1 9SY
United Kingdom
Cupar
KY15 5UP
United Kingdom
Hamilton
ML3 0TA
United Kingdom
17 Old Edinburgh Road
Inverness
IV2 3HG
United Kingdom
2-4 Waterloo Place
Edinburgh
EH1 3EG
United Kingdom
Stirling
FK8 1DX
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| IPD sharing plan | The data sharing plans for the current study are unknown and will be made available at a later date |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No | ||
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Protocol file | version V1.1 | 03/09/2020 | 06/04/2021 | No | No |
Additional files
- ISRCTN76339681_PROTOCOL_V1.1_3Sept2020.pdf
- Uploaded 06/04/2021
Editorial Notes
06/04/2021: Uploaded protocol V1.1, 3 September 2020 (not peer reviewed).
04/03/2021: Trial’s existence confirmed by Yorkshire and The Humber - South Yorkshire Research Ethics Committee.
