GenOMICC study - Looking at DNA of patients with severe illness and injury to find the genes that cause some people to become very unwell and be admitted to intensive care

ISRCTN ISRCTN16993428
DOI https://doi.org/10.1186/ISRCTN16993428
IRAS number 189676
Secondary identifying numbers IRAS 189676 (Scotland), IRAS 269326 (England/Wales)
Submission date
01/06/2021
Registration date
25/06/2021
Last edited
17/01/2025
Recruitment status
Recruiting
Overall study status
Ongoing
Condition category
Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English Summary

Background and study aims
This study aims to identify genetic predisposition to specific syndromes of critical illness. Specifically, susceptibility to life-threatening infections caused by an identified pathogen, and susceptibility to death following the onset of organ failure due to sepsis or sterile injury. In order to maximise the probability of identifying host genetic loci associated with susceptibility, we will restrict some analyses to younger individuals in good general health, and lacking in known predisposing factors.
The same principle was used to determine an upper age limit for inclusion for some analyses. With advancing age, there is an increase in undiagnosed comorbidity, frailty, and susceptibility to serious complications of infection or critical injury. There is therefore an increase in the probability of susceptibility to, and mortality from, critical illness that is consequent upon non-genetic factors.

Who can participate?
Prospective recruitment - Patients meeting the entry criteria (5.5) will be asked to provide informed consent, and a single DNA sample.
Recruitment of survivors - The group of survivors eligible for recruitment for this study are generally healthy individuals who have suffered critical illness.

What does the study involve?
Informed consent, and a single DNA sample.

What are the possible benefits and risks of participating?
There are no potential benefits to an individual from participation. However, if successfully completed, this study may provide fundamental insights into the pathogenesis of critical illness in infectious diseases and may ultimately lead to the development of novel treatments that could prevent flu and other diseases.

Where is the study run from?
The University of Edinburgh (UK)

When is the study starting and how long is it expected to run for?
December 2014 to August 2029

Who is funding the study:
Sepsis Research (FEAT), Intensive Care Society, the Wellcome Trust, and the Medical Research Council (UK)

Who is the main contact:
Dr Kenneth Baillie,
Genomic.study@ed.ac.uk

Study website

Contact information

Dr Kenneth Baillie
Scientific

Roslin Institute
University of Edinburgh
Easter Bush
Midlothian
Edinburgh
EH25 9RG
United Kingdom

ORCiD logoORCID ID 0000-0001-5258-793X
Phone +44 (0)300 365 7660
Email genomicc@roslin.ed.ac.uk

Study information

Study designMulti-centre prospective observational study
Primary study designObservational
Secondary study designCase-control study
Study setting(s)Hospital
Study typeScreening
Participant information sheet Patient information material can be found at https://genomicc.org/investigators/protocol/uk/
Scientific titleGenetics Of susceptibility and Mortality In Critical Care (GenOMICC)
Study acronymGenOMICC
Study hypothesisWhat are the genes that cause some people to be susceptible to life-threatening infection, or death from critical illness?
Ethics approval(s)1. Approved 08/12/2016, Scotland A REC (2nd Floor Waverley Gate, 2 - 4 Waterloo Place, Edinburgh, EH1 3EG, UK; +44(0)131 465 5678; Manx.Neill@nhslothian.scot.nhs.uk), ref 15/SS/0180/AM01/1
2. Approved 10/10/2019, Health Research Authority (Skipton House, 80 London Road, London, SE1 6LH, UK; +44 (0)20 7972 2545; hra.approval@nhs.net), ref: 19/WM/0247
ConditionGenetics of susceptibility and mortality in life-threatening infection
InterventionCurrent interventions as of 15/04/2024:
People with severe illness (such as COVID-19, influenza, sepsis, and other causes of critical illness), and healthy volunteers (for comparison) will be approached to participate in the study.

Participants will be asked to consent by signing a consent form. A single blood sample will be taken (roughly 4 ml) to get a DNA sample. If a participant is unable to give a blood sample for any reason, a sample of saliva may be taken instead in some circumstances. For those participants who have been discharged from the hospital, a research nurse will arrange a home visit at a convenient time, or a saliva sample kit can be sent if preferred.




Previous interventions:
People with severe illness (such as COVID-19, influenza, sepsis, and other causes of critical illness), and healthy volunteers (for comparison) will be approached to participate in the study.

Participants will be asked to consent by signing a consent form. A single blood sample will be taken (9 ml; roughly 2 teaspoons) to get a DNA sample. If a participant is unable to give a blood sample for any reason, a sample of saliva may be taken instead in some circumstances. For those participants who have been discharged from the hospital, a research nurse will arrange a home visit at a convenient time, or a saliva sample kit can be sent if preferred.
Intervention typeOther
Primary outcome measure60-day survival measured using electronic medical records post recruitment
Secondary outcome measuresThe genetic data from severely ill patients will be measured in comparison with the genetic data from volunteers who suffered only mild symptoms using whole genome sequencing and/or SNP arrays at one-time point to try to determine which genes might play a part in an illness progressing to critical illness
Overall study start date01/12/2014
Overall study end date31/08/2029

Eligibility

Participant type(s)Patient
Age groupMixed
SexBoth
Target number of participants40,000
Participant inclusion criteria1. Patients will be recruited who:
1.1. Are deemed, in the view of the treating physician, to require continuous cardiovascular or respiratory monitoring or invasive mechanical ventilation,
1.2. AND provide appropriate consent or assent,
1.3. AND present with one of the following primary diagnoses:
2. Group 1: specific infectious syndromes in highly-selected patients
2.1. COVID-19. Confirmed or suspected COVID-19.
2.2. Influenza. Confirmed or suspected infection with influenza virus.
2.3. Secondary pneumonia. Acute pneumonia complicating confirmed infection with influenza virus.
2.4. Dengue. Confirmed or suspected infection with dengue virus.
2.5. RSV. Confirmed infection with respiratory syncytial virus.
2.6. Emerging infections. Confirmed or suspected infection with an emerging infection (see below).
3. Group 2: specific non-infectious critical illness syndromes:
3.1. Burns. Full-thickness burns covering  > 20% of body surface area.
3.2. Emerging critical illness syndromes. Confirmed or suspected presence of an emerging critical illness syndrome. These are unexplained or idiosyncratic presentations of acute organ injury, or suspected reactions to therapeutic agents, including:
3.3. acute disease associated with inhalation of noxious substances or vapours, such as "vaping"
3.4. acute disease associated with CAR T-cell therapy
4. Group 3: extreme critical illness
4.1. Extra-corporeal life support. Requirement for continuous veno-venous extra-corporeal support for respiratory failure of any aetiology.
5. Group 4: common/nonspecific critical illness syndromes:
5.1. Cellulitis. Soft tissue infections causing systemic sepsis.
5.2. Pneumonia. Primary pneumonia of any aetiology, with radiographic changes at presentation to critical care. Pneumonia is defined as: symptoms and signs consistent with an acute lower respiratory tract infection associated with new radiographic shadowing for which there is no other explanation (eg, not pulmonary oedema or infarction). Where this illness is the primary reason for hospital admission and is managed as pneumonia, the patient is eligible for inclusion.(Harris et al, 2011). No microbiology information is required to meet this entry criterion.
5.3. Pancreatitis. Pancreatitis of any aetiology.
5.4. Emerging Infections
Emerging infections are by their nature unpredictable and present a significant challenge to the international research community. In order to ensure research preparedness, in accordance with the principles laid out by the International Severe Acute and Emerging Infection Consortium (ISARIC)(Dunning et al. 2014), patients will be recruited to this study if they have confirmed or suspected infection with a novel pathogen, a new strain of an existing pathogen, or a re-emerging known pathogen, that causes life-threatening illness. This will include the Middle East Respiratory Syndrome (MERS) and Severe Acute Respiratory Syndrome (SARS), highly pathogenic strains of influenza, Ebola virus disease and other epidemics of viral haemorrhagic fever.
Participant exclusion criteriaCurrent participant exclusion criteria as of 25/01/2023:
There are no exclusion criteria. All consenting patients can be recruited.



Previous participant exclusion criteria:
Exclusion criteria do not apply to COVID-19. All consenting COVID-19 patients will be included. For all inclusion categories apart from COVID-19, patients who are functionally limited by any comorbid illness (such as frailty, heart failure, chronic obstructive pulmonary disease (COPD), or reduced exercise tolerance of any cause) or have significant immunosuppression (such as cancer chemotherapy or acquired immune deficiency syndrome) will be excluded from this study.
Recruitment start date01/01/2016
Recruitment end date31/08/2029

Locations

Countries of recruitment

  • Canada
  • England
  • Ireland
  • Northern Ireland
  • Scotland
  • United Kingdom
  • Wales

Study participating centres

Royal Infirmary of Edinburgh
51 Little France Crescent
Edinburgh
EH16 4SA
United Kingdom
Western General Hospital
Crewe Road
Edinburgh
EH4 2XU
United Kingdom
St Johns Hospital
Howden W Road
Howden
Livingston
EH54 6PP
United Kingdom
Royal Hospital for Sick Children
Royal Infirmary of Edinburgh
51 Little France Crescent
Edinburgh
EH16 4SA
United Kingdom
Airedale NHS Foundation Trust
Skipton Road
Steeton
KEIGHLEY
BD20 6TD
United Kingdom
Alder Hey Children's NHS Foundation Trust
Eaton Road
Liverpool
L12 2AP
United Kingdom
Royal Gwent Hospital
Cardiff Road
Newport
NP20 2UB
United Kingdom
The Grange Hospital
Llanyravon
CWNBRAN
NP44 2XJ
United Kingdom
Ashford and St Peters Hospital
Guildford Road
CHERTSEY
KT16 0PZ
United Kingdom
Queens Hospital
Barking, Havering and Redbridge University Hospitals NHS Trust
Rom Valley Way
ROMFORD
RM7 0AG
United Kingdom
Barnsley District General Hospital
Barnsley Hospital NHSFT
Gawber Road
BARNSLEY
S75 2EP
United Kingdom
The Royal London Hospital
Whitechapel Road, Whitechapel
London
E1 1BB
United Kingdom
Bedford Hospital NHS Trust
King's Place
Britannia Road
BEDFORD
MK42 9DJ
United Kingdom
BELFAST HEALTH AND SOCIAL CARE TRUST
Royal Victoria Hospital, 274 Grosvenor Road, Belfast
Belfast
BT12 6BA
United Kingdom
Belfast City Hospital
Lisburn Rd
Belfast
BT9 7AB
United Kingdom
St Bartholomew's Hospital
W Smithfield
London
EC1A 7BE
United Kingdom
Newham University Hospital
Glen Rd
London
E13 8SL
United Kingdom
Whipps Cross Hospital
Whipps Cross Rd, Leytonstone
London
E11 1NR
United Kingdom
Mile End Hospital
via A104, Bancroft Rd
London
E1 4DG
United Kingdom
Ysbyty Gwynedd
Penrhosgarnedd
BANGOR
LL57 2PW
United Kingdom
Glan Clwyd Hospital
Sarn Lan, Bodelwyddan
Denbighshire
LL18 5UJ
United Kingdom
Wrexham Maelor Hospital
Crosenewydd Road
WREXHAM
LL13 7TD
United Kingdom
Birmingham Women’s and Children’s Hospital
Steelhouse Lane
BIRMINGHAM
B4 6NH
United Kingdom
Blackpool Teaching Hospitals NHS Foundation Trust
Blackpool Victoria Hospital
Whinney Heys Road, Lancashire
BLACKPOOL
FY3 8NR
United Kingdom
Bolton NHS Foundation Trust,
Minerva Road, Farnworth
Bolton
BL4 0JR
United Kingdom
Bradford Teaching Hospitals NHS Foundation Trust
Duckworth Lane
BRADFORD
BD9 6R
United Kingdom
Princess Royal Hospital
Lewes Road
Haywards Heath
RH16 4EX
United Kingdom
Royal Sussex County Hospital
Eastern Road
Brighton
BN2 5BE
United Kingdom
ROYAL ALEXANDRA CHILDREN'S HOSPITAL
Royal Sussex County Hospital
Eastern Road
BRIGHTON
Brighton
BN2 5BE
United Kingdom
Stoke Mandeville Hospital
Buckinghamshire Healthcare NHS Trust
Mandeville Road
AYLESBURY
HP21 8AL
United Kingdom
Calderdale Royal Hospital
Salterhebble
HALIFAX
HX3 0PW
United Kingdom
Huddersfield Royal Infirmary
Acre Street
Lindley
HUDDERSFIELD
HD3 3EA
United Kingdom
Addenbrooke's Hospital
Hills Road
Cambridge
CB2 0QQ
United Kingdom
University Hospital of Wales and Queen Elizabeth II Wales
Heath Park
CARDIFF
CF14 4XW
United Kingdom
Chelsea and Westminster Hospital,
369 Fulham Road
London
SW10 9NH
United Kingdom
West Middlesex University Hospital
R&D Office
4thFloor, East wing
West Middlesex University Hospital
Twickenham Road
ISLEWORTH
TW7 6AF
United Kingdom
Chesterfield Royal Hospital
Chesterfield Road, Calow
Chesterfield
S44 5BL
United Kingdom
Countess of Chester Hospital
Liverpool Road
Chester
CH2 1UL
United Kingdom
University Hospital of North Durham
North Road
DURHAM
DH1 5TW
United Kingdom
County Durham and Darlington NHS Foundation Trust,
Darlington Memorial Hospital
Hollyhurst Road
Darlington
DL3 6HX
United Kingdom
Croydon University Hospital,
530 London Road
Croydon
CR7 7YE
United Kingdom
Royal Glamorgan Hospital,
Ynysmaerdy, Llantrisant
Rhondda Cynon Taf
CF72 8XR
United Kingdom
Prince Charles Hospital
Gurnos Road
MERTHYR TYDFIL
CF47 9DT
United Kingdom
Princess of Wales Hospital
Coity Road
BRIDGEND
CF31 1RQ
United Kingdom
Darent Valley Hospital
Darenth Wood Rd
Dartford
DA2 8DA
United Kingdom
Dorset County Hospital
Williams Avenue
Dorchester
DT1 2JY
United Kingdom
East and North Hertforshire NHS Trust
Lister Hospital
Coreys Mill Lane
Stevenage
SG1 4AB
United Kingdom
Macclesfield District General Hospital,
East Cheshire NHS Trust
Victoria Road
Macclesfield
SK10 3BL
United Kingdom
The William Harvey Hospital
Kennington Road
ASHFORD
TN24 0LZ
United Kingdom
Queen Elizabeth the Queen Mother Hospital
St Peters Road
KENT
Margate
CT9 4AN
United Kingdom
Kent and Cantebury Hospital
Ethelbert Road
Kent
Kent
CT1 3NG
United Kingdom
Royal Blackburn Teaching Hospital
Haslingden road
Lancashire
Blackburn
BB2 3HH
United Kingdom
ESNEFT Colchester General Hospital,
Turner Road
Essex
Colchester
CO4 5JR
United Kingdom
ESNEFT Ipswich Hospital
Health Road
Ipswich
IP4 5PD
United Kingdom
Eastbourne District General Hospital and Conquest Hospital,
Kings Drive, East Sussex
Eastbourne
BN21 2UD
United Kingdom
Frimley Health NHS Foundation Trust
Pine House
Frimley
Surrey
Camberley
GU16 7UJ
United Kingdom
Queen Elizabeth Hospital,
Queen Elizabeth Avenue
Sheriff Hill
Gateshead
NE9 6SX
United Kingdom
Gloucestershire Royal Hospital
Great Western Road
Gloucester
GL1 3NN
United Kingdom
Aberdeen Royal Infirmary
Foresterhill Road
Aberdeen
AB25 2ZN
United Kingdom
UCL Great Ormond Street Institute of Child Health (ICH) & Great Ormond Street Hospital (GOSH)
30 Guilford Street
London
WC1N 1EH
United Kingdom
Great Western Hospital NHS Foundation Trust
Great Western Hospital
Marlborough Road
Wiltshire
Swindon
SN3 6BB
United Kingdom
Guy's Hospital,
Greta Maze Pond
London
SE1 9RT
United Kingdom
Guy's and St Thomas' NHS Foundation Trust
Sydney Street
London
SW3 6NP
United Kingdom
Royal Hampshire County Hospital
Romsey Rd
Winchester
SO22 5DG
United Kingdom
Basingstoke and North Hampshire Hospital
Aldermaston Road
Hampshire
Basingstoke
RG24 9NA
United Kingdom
Harrogate District Hospital NHS Foundation Trust
Lancaster Park Road
North Yorkshire
Harrogate
HG2 7SX
United Kingdom
Homerton University Hospital NHS Foundation Trust
Homerton Row
London
E9 6SR
United Kingdom
Hull Royal Infirmary,
Anlaby Rd
Hull
HU3 2JZ
United Kingdom
Withybush Hospital
Fishguard Road
Pembrokeshire
Haverfordwest
SA61 2PZ
United Kingdom
Glangwili General Hospital
Dolgwili Road
CARMARTHEN
SA31 2AF
United Kingdom
Tŷ Geraint Bronglais General Hospital
Caradoc Rd
ABERYSTWYTH
SY23 1ER
United Kingdom
Prince Philip Hospital,
Dafen
Llanelli
SA14 8QF
United Kingdom
St. Mary’s Hospital
Praed Street
London
W2 1NY
United Kingdom
Charing Cross Hospital
Fulham Palace Road
London
W6 8RF
United Kingdom
Hammersmith Hospital
150, Du Cane Road
London
W12 0HS
United Kingdom
St Mary's Hospital,
Parkhurst Road
Isle of Wight
Newport
PO30 5TG
United Kingdom
James Paget Hospital,
Lowestoft Road
Gorleston-on-Sea
Norfolk
Great Yarmouth
NR31 6LA
United Kingdom
Kettering General Hospital NHS Foundation Trust,
Rothwell Road
Kettering
Northants
NN16 8UZ
United Kingdom
Kings College Hospital,
Denmark Hill
London
Kings College Hospital, Denmark Hill, London, SE5 9RS
United Kingdom
Kingston Hospital NHS Foundation Trust,
Galsworthy Road, Surrey
Kingston Upon Thames
KT2 7QB
United Kingdom
Royal Preston Hospital,
Sharoe Green Lane
Fulwood
Preston
PR2 9HT
United Kingdom
St James University Hospital
Beckett Street
LEEDS
LS9 7TF 
United Kingdom
Leeds General Infirmary
Great George St
Leeds
LS1 3EX
United Kingdom
Queen Elizabeth Hospital,
Stadium Road
Woolwich
SE18 4QH
United Kingdom
University Hospital Lewisham
Lewisham High St
Lewisham
London
SE13 6LH
United Kingdom
Liverpool Heart And Chest Hospital NHS Foundation Trust,
Galsworthy Road
Liverpool_Chest Upon Thames
Surrey
KT1 7QB
United Kingdom
The Royal Liverpool University Hospital,
Prescot Street
Liverpool
L7 8XP
United Kingdom
Aintree University Hospital
Longmoor Lane
Liverpool
L9 7AL
United Kingdom
Northwick Park Hospital
Watford Road
Harrow
HA1 3UJ
United Kingdom
Ealing Hospital
Uxbridge Road
Southall
UB1 3HW
United Kingdom
Maidstone and Tunbridge Wells NHS Trust
Hermitage Lane
Maidstone
Kent
ME16 9QQ
United Kingdom
Tunbridge Wells Hospital
Tonbridge Road
PEMBURY
TN2 4QJ
United Kingdom
Manchester University Manchester Royal Infirmary NHS Foundation Trust
North Road
Manchester
M13 9WL
United Kingdom
Wythenshawe Hospital
Southmoor Road
Manchester
M23 9QZ
United Kingdom
Royal Manchester Children's Hospital 
North Road
Oxford Road Campus
Manchester
M13 9WL
United Kingdom
Medway NHS Foundation Trust
Gate Lodge, Maritime Hospital
Windmill Road
Gillingham
Kent
ME7 5NY
United Kingdom
Basildon University Hospital,
Nethermayne
Basildon
SS16 5NL
United Kingdom
Southend Hospital
Prittlewell Chase
WESTCLIFF-ON-SEA
SS0 0RY
United Kingdom
Broomfield Hospital,
Broomfield Hospital, Court Road
Chelmsford
CM1 7ET
United Kingdom
Pinderfields Hospital,
Mid Yorkshire Hospitals NHS Trust
Aberford Road
Wakefield
WF1 4AL
United Kingdom
Milton Keynes University Hospital
Standing Way
Eaglestone
Milton Keynes
MK6 5LD
United Kingdom
Crosshouse Hospital
Kilmarnock Road
KILMARNOCK
KA2 0BE
United Kingdom
University Hospital Ayr
Dalmellington Rd
AYR
KA6 6DX
United Kingdom
Borders General Hospital
Huntlyburn Terrace
MELROSE
TD6 9BS
United Kingdom
Dumfries and Galloway Royal Infirmary
Cargenbridge
DUMFRIES
DG2 8RX
United Kingdom
Victoria Hospital
Hayfield Road
KIRKCALDY
KY2 5AH
United Kingdom
Forth Valley Royal Hospital
Stirling Road
LARBERT
FK5 4WR
United Kingdom
Queen Elizabeth University Hospital
1345 Govan Road
Glasgow
G51 4TF
United Kingdom
Glasgow Royal Infirmary
10-16 Alexandra Parade
Glasgow
G31 2ER
United Kingdom
Royal Hospital for Children,
Queen Elizabeth University Hospital
1345 Govan Road
Glasgow
G51 4TF
United Kingdom
Royal Alexandra Hospital
Corsebar Road
Paisley
PA2 9PN
United Kingdom
Raigmore Hospital
Old Perth Road
Inverness
IV2 3UJ
United Kingdom
University Hospital Hairmyres
Eaglesham Road
East Kilbride
G75 8RG
United Kingdom
University Hospital Wishaw,
50 Netherton Street
Wishaw
ML2 0DP
United Kingdom
University Hospital Monklands
Monkscourt Avenue
AIRDRIE
ML6 0JS
United Kingdom
Golden Jubilee National Hospital
Agamemnon Street
Clydebank
Glasgow
G81 4DY
United Kingdom
Norfolk & Norwich University NHS Foundation Trust,
Colney Lane
Norwich
NR4 7UY
United Kingdom
Southmead Hospital
Westbury-on-Trym
Bristol
BS10 5NB
United Kingdom
Cumberland Infirmary
New Town Road
Carlisle
Cumbria
CA2 7HY
United Kingdom
West Cumberland Hospital
Homewood Road
Whitehaven
CUMBRIA
CA28 8JG UK
United Kingdom
North Middlesex University Hospital NHS Trust
Sterling Way
London
N18 1QX
United Kingdom
University Hospital of North Tees
Hardwick
STOCKTON ON TEES
TS19 8PE
United Kingdom
Hinchingbrooke Hospital
Parkway Hinchingbrooke
HUNTINGDON
PE29 6NT
United Kingdom
Peterborough City Hospital
Bretton gate
PETERBOROUGH
PE3 9GZ
United Kingdom
Northampton General Hospital NHS Trust
Cliftonville
NORTHAMPTON
NN1 5BD
United Kingdom
North Devon District Hospital
Raleigh Park
BARNSTAPLE
EX31 4JB
United Kingdom
Antrim Area Hospital,
Bush Road
Antrim
BT41 2RL
United Kingdom
Diana, Princess of Wales Hospital
Scartho Road
GRIMSBY
DN33 2BA
United Kingdom
Scunthorpe General Hospital,
Cliff Gardens
Scunthorpe
DN15 7BH
United Kingdom
North Tyneside General Hospital,
Rake Lane
North Shields
NE29 8NH
United Kingdom
Wansbeck General Hospital
Woodhorn Ln
Ashington
NE63 9JJ
United Kingdom
Northumbria Specialist Emergency Care Hospital
Northumbria Way
Cramlington
NE23 6NZ
United Kingdom
Nottingham University Hospital Queens
Queens Medical Centre Campus
NOTTINGHAM
NG7 2UH
United Kingdom
John Radcliffe Hospital
Headley Way
Headington
OXFORD
OX3 9DU
United Kingdom
Royal Papworth Hospital NHS Foundation Trust
Papworth Road
CAMBRIDGE
CB2 0AY
United Kingdom
Queen Alexandra Hospital
Portsmouth
COSHAM
PO6 3LY
United Kingdom
Queen Victoria Hospital
Holtye Rd
East Grinstead
RH19 3DZ
United Kingdom
Royal Berkshire Hospital
London Road
BERKSHIRE
Reading
RG1 5AN
United Kingdom
Royal Cornwall Hospital
Treliske
Truro
TR1 3LJ
United Kingdom
Royal Devon and Exeter Foundation Trust
Barrack Road
EXETER
EX2 5DW
United Kingdom
Royal Free Hospital NHS Trust,
Pond St
Hampstead
London
NW3 2QG
United Kingdom
Barnet Hospital
Wellhouse Lane
BARNET
EN5 3DJ
United Kingdom
Royal Surrey County Hospital,
Egerton Road
Guildford
GU2 7XX
United Kingdom
Royal United Hospitals Bath NHS Foundation Trust,
Combe Park
Bath
BA1 3NG
United Kingdom
Salford Royal NHS Foundation Trust
544 Eccles New Road
Salford
MANCHESTER
M6 8HD
United Kingdom
Salisbury District Hospital
Odstock Road
SALISBURY
SP2 8BJ
United Kingdom
Sheffield Childrens Hospital
Western Bank
SHEFFIELD
S10 2TH
United Kingdom
The Royal Hallamshire Hospital
Glossop Road
SHEFFIELD
S10 2JF
United Kingdom
Northern General Hospital
Herries Rd
Sheffield
S5 7AU
United Kingdom
King’s Mill Hospital
Mansfield Road
SUTTON-IN-ASHFIELD
NG17 4JL
United Kingdom
Royal Shrewsbury Hospital
Mytton Oak Road
Shrewsbury
SHROPSHIRE
SY3 8XQ
United Kingdom
Princess Royal Hospital
Apley Castle
Apley
TELFORD
TF1 6TF
United Kingdom
Musgrove Park Hospital,
Parkfield Drive
Taunton
SOMERSET
C Shovelton/ P Doble, Critical Care Research Nurses Old Building, generic office, Vascular dept Somerset NHS Foundation Trust Musgrove Park Hospital, Parkfield Drive, Taunton SOMERSET TA1 5DA
United Kingdom
James Cook University Hospital
Marton road
Middlesbrough
CLEVELAND
TS4 3BW
United Kingdom
Sunderland Royal Hospital
Kayll Road
SUNDERLAND
SR4 7TP
United Kingdom
Warwick Hospital,
Lakin road
Warwick
CV34 5BW
United Kingdom
Craigavon Area Hospital
68 Lurgan Road
PORTADOWN
BT63 5QQ
United Kingdom
Southport and Ormskirk Hospitals NHS Trust
Southport DGH
Town lane
Kew
SOUTHPORT
PR8 6PN
United Kingdom
St Georges Hospital NHS Foundation Trust,
Blackshaw Road
TOOTING
London
SW17 0QT
United Kingdom
Whiston Hospital, Warrington Road, Prescot, L35 5DR
Warrington Road
Prescot
L35 5DR
United Kingdom
Stepping Hill Hospital
Stockport NHS Foundation
Poplar Grove, Hazel Grove
STOCKPORT
SK2 7JE
United Kingdom
East Surrey Hospital
Canada Avenue
REDHILL
RH1 5RH
United Kingdom
Morriston Hospital
Heol Maes Eglwys
MORRISTON
SWANSEA
SA6 6NL
United Kingdom
Tameside General Hospital
Fountain Street
ASHTON-UNDER-LYNE
OL6 9R
United Kingdom
Ninewells Hospital and Medical School
James Arrott Drive
DUNDEE
DD1 9SY
United Kingdom
The Christie NHS Foundation Trust,
Wilmslow Road
Manchester
M20 4BX
United Kingdom
Russells Hall Hospital,
Pensnett Rd
Dudley
DY1 2HQ
United Kingdom
Royal Victoria Infirmary
Queen Victoria Road
NEWCASTLE UPON TYNE
NE1 4LP
United Kingdom
Fairfield General Hospital
Rochdale Old Road
BURY
BL9 7TD
United Kingdom
The Royal Oldham Hospital
Rochdale Road
OLDHAM
OL1 2JH
United Kingdom
North Manchester General Hospital
Delaunays Road
Crumpsall
MANCHESTER
M8 5RB
United Kingdom
The Princess Alexandra Hospital
Hamstel Road
Harlow
ESSEX
CM20 1QX
United Kingdom
The Queen Elizabeth Hospital NHS Foundation Trust
Gayton Road
KING’S LYNN
PE30 4ET
United Kingdom
Rotherham Hospital
Moorgate Road
ROTHERHAM
S60 2UD
United Kingdom
The Royal Marsden Hospital
Fulham Road
LONDON
SW3 6JJ
United Kingdom
New Cross Hospital
The Royal Wolverhampton NHS Trust
The Chesnuts
WOLVERHAMPTON
WV10 0QP
United Kingdom
Torbay Hospital
Lowes Bridge
TORQUAY
TQ2 7AA
United Kingdom
Lincoln County Hospital
Greetwell Road
LINCOLN
LN2 5QY
United Kingdom
Pilgrim Hospital
Sibsey Rd
BOSTON
PE21 9QS
United Kingdom
University College Hospital
235 Euston Road
LONDON
NW1 2BU
United Kingdom
National Hospital for Neurology and Neurosurgery
Queen Square
LONDON
WC1N 3BG
United Kingdom
Royal Derby Hospital
Uttoxeter Road
DERBY
DE22 3NE
United Kingdom
Queen’s Hospital
Belvedere Road
Burton Upon Trent
STAFFORDSHIRE
DE13 0RB
United Kingdom
Southampton General Hospital
Tremona Road
Southampton
HAMPSHIRE
SO16 6YD
United Kingdom
Queen Elizabeth Hospital
Heritage Building
Edgbaston
BIRMINGHAM
B15 2TH
United Kingdom
Birmingham Heartlands Hospital
Bordesley Green Road
BIRMINGHAM
B9 5SS
United Kingdom
Good Hope Hospital
Rectory Road
SUTTON
COLDFIELD
B75 7RR
United Kingdom
Bristol Royal Infirmary
Upper Maudlin Street
BRISTOL
BS2 8HW
United Kingdom
University Hospital Coventry
Clifford Bridge Road
COVENTRY
CV2 2DX
United Kingdom
Royal Bournemouth Hospital
Castle Lane East
BOURNEMOUTH
BH7 7DW
United Kingdom
Poole Hospital
Longfleet House
POOLE
BH15 2JB
United Kingdom
Leicester Royal Infirmary
Infirmary Square
LEICESTER
LE1 5WW
United Kingdom
Glenfield Hospital
Groby Rd
Leicester
LE3 9QP
United Kingdom
Leicester Children’s Hospital
Leicester Royal Infirmary
Infirmary Square
LEICESTER
LE1 5WW
United Kingdom
Royal Lancaster Infirmary,
Ashton Road
LANCASTER
LA1 1RP
United Kingdom
Furness General Hospital
Dalton Lane
BARROW IN FURNESS
LA14 4LF
United Kingdom
University Hospitals of North Midlands NHS Trust
Newcastle Road
Stoke-on-Trent
STAFFORDSHIRE
ST4 6QG
United Kingdom
Derriford Hospital
Derriford Road
PLYMOUTH
PL6 5FP
United Kingdom
Walsall Manor Hospital
Moat Road
WALSALL
WS2 9PS
United Kingdom
Warrington Hospital
Lovely Lane
WARRINGTON
WA5 1QG
United Kingdom
Watford General Hospital NHS Trust
Vicarage Road
WATFORD
WD18 0HB
United Kingdom
West Suffolk NHS Foundation Trust
Hardwick Lane
Bury St Edmunds
SUFFOLK
IP33 2QZ
United Kingdom
Worthing Hospital
Lyndhurst Road
WORTHING
BN11 2DH
United Kingdom
St Richard’s Hospital
Spitalfield Lane
CHICHESTER
PO19 6SE
United Kingdom
Whittington Health NHS Trust
Magdala Avenue
LONDON
N19 5NF
United Kingdom
Arrowe Park Hospital
Arrowe Park Road
UPTON
BIRKENHEAD
CH49 5PE
United Kingdom
Alexandra Hospital
Woodrow Drive
REDDITCH
B98 7UB
United Kingdom
Worcestershire Royal Hospital,
Charles Hastings Way
Worcester
WR5 1DD
United Kingdom
Royal Albert Edward Infirmary
The Hawthorns
Wigan Lane
WIGAN
WN1 2NN
United Kingdom
Hereford County Hospital
Union Walk
HEREFORD
HR1 2ER
United Kingdom
Yeovil District Hospital
Higher Kingston
YEOVIL
BA21 4AT
United Kingdom
York Teaching Hospitals NHS Foundation Trust
Wiggington Road
YORK
YO31 8HE
United Kingdom
Scarborough General Hospital
Woodlands Drive North
SCARBOROUGH
YO12 6QL
United Kingdom
Leighton Hospital
Leighton
Crewe
CW1 4QJ
United Kingdom
Ulster Hospital
Upper Newtownards Rd
Dundonald
Belfast
BT16 1RH
United Kingdom
Bristol Royal Hospital for Children
Upper Maudlin Street
Bristol
BS2 8BJ
United Kingdom
Antrim Area Hospital
45 Bush Rd
Antrim
BT41 2RL
United Kingdom
Altnagelvin Area Hospital
Glenshane Road
Londonderry
BT47 6SB
United Kingdom
Royal Brompton Hospital
Sydney Street
London
SW3 6NP
United Kingdom
Midland Metropolitan University Hospital
Grove Lane
Smethwick
B66 2QT
United Kingdom

Sponsor information

Accord (United Kingdom)
Research organisation

47 Little France Cres
Edinburgh
EH16 4TJ
United Kingdom

Phone +44 (0)131 242 3330
Email ACCORD@nhslothian.scot.nhs.uk
Website http://accord.scot/
ROR logo "ROR" https://ror.org/01x6s1m65

Funders

Funder type

Charity

Sepsis Research (FEAT)

No information available

Intensive Care Society

No information available

Wellcome Trust
Private sector organisation / Trusts, charities, foundations (both public and private)
Alternative name(s)
Wellcome, WT
Location
United Kingdom
Medical Research Council
Government organisation / National government
Alternative name(s)
Medical Research Council (United Kingdom), UK Medical Research Council, MRC
Location
United Kingdom

Results and Publications

Intention to publish date31/08/2030
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryStored in publicly available repository
Publication and dissemination planPeer-reviewed scientific journals, internal report, conference presentation, publication on website
IPD sharing planThe datasets generated during and/or analysed during the current study will be stored in a publicly available repository (genomicc.org/data).
Type of data that will be shared: summary statistics for GWAS data
When the data will become available and for how long: data will be available as soon as the analysis is completed to a satisfactory standard and will be maintained indefinitely.
By what access criteria the data will be shared including with whom, for what types of analyses, and by what mechanism: Summary data will be publicly available to the public when the analysis has been completed to a satisfactory standard. Prior to the completion of the analysis, the summary statistics, or intermediate files may be made available to collaborators to assist with other analysis plans
Whether consent from participants was obtained: consent has been obtained. The data to be shared openly is summary data and does not contain any identifiable information or data relating to individual genomes
Comments on data anonymisation, any ethical or legal restrictions, any other comments: The summary data/summary statistics do not contain data relating to individual genomes or identifiable information. The exported data are summary statistics that do not contain individual information about individuals. The researchers are using variants with a minor allele frequency (MAF) of 1% which avoids identification of individuals using genetic data (because at least 1% of the population will have the minor allele of the variant which is enough people to be impossible to identify).

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Preprint results 08/05/2021 01/06/2021 No No
Preprint results 08/03/2021 01/06/2021 No No
Preprint results 22/04/2021 01/06/2021 No No
Results article genome-wide association study results 04/03/2021 01/06/2021 Yes No
Results article Critical COVID-19 results 07/03/2022 31/03/2022 Yes No
Results article 17/05/2023 25/05/2023 Yes No
HRA research summary 28/06/2023 No No
HRA research summary 28/06/2023 No No

Editorial Notes

17/01/2025: The study participating centres City Hospital, Sandwell General Hospital were removed and Midland Metropolitan University Hospital was added.
15/04/2024: The following updates were made:
1. Interventions were changed.
2. The Royal Brompton Hospital was added as a study participating centre.
30/01/2024: The study participating centres were updated to remove Mater Hospital, Barts-Nightingale, Doncaster & Bassetlaw Hospitals NHS Trust, Epsom and St Helier University Hospitals NHS Trust, Freeman Hospital, The Walton Centre NHS Foundation Trust, and Royal National Orthopaedic Hospital; and add Bristol Royal Hospital for Children, Antrim Area Hospital and Altnagelvin Hospital.
11/10/2023: The study participating centres were updated to remove Mid Cheshire Hospitals NHS Foundation Trust and add Ulster Hospital.
25/05/2023: Publication reference added.
25/01/2023: The following changes have been made:
1. Study design was changed from "Multicentre prospective and retrospective interventional non-randomized study" to "Multi-centre prospective observational study".
2. Primary study design was changed from "interventional" to "observational".
3. Secondary study design was changed from "non-randomised study" to "case-control study".
4. Intervention type was changed from "Genetic" to "Other".
5. Primary outcome measure was changed from "Mortality measured through electronic medical records at 60 days from the first time the patient met the medical criteria" to "60-day survival measured using electronic medical records post recruitment"
6. Secondary outcome measure was changed from "Genetic data will be measured by Whole Genome Sequencing and/or SNP arrays depending on availability, background ethnicity of samples and technology at the time of sequencing. Measurement will be of the differences in allele frequency between cases (ICU patients, defined in protocol) and controls (matched controls, without severe phenotype)." to "The genetic data from severely ill patients will be measured in comparison with the genetic data from volunteers who suffered only mild symptoms using whole genome sequencing and/or SNP arrays at one time point to try to determine which genes might play a part in an illness progressing to critical illness".
7. Participant information sheet link was updated.
03/11/2022: Leighton Hospital was added as a trial participating centre.
30/06/2022: Mid Cheshire Hospitals NHS Foundation Trust was added as a trial participating centre. PubMed addresses added for publications.
8. Recruitment start date was changed from 04/07/2019 to 01/01/2016.
31/03/2022: Publication reference added.
09/06/2021: Trial's existence confirmed by Scotland A REC.