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
Clinical Trials Information System (CTIS) Nil known
Integrated Research Application System (IRAS) 189676
Protocol serial number IRAS 189676 (Scotland), IRAS 269326 (England/Wales)
Sponsor Accord (United Kingdom)
Funders Sepsis Research (FEAT), Intensive Care Society, Wellcome Trust, Medical Research Council
Submission date
01/06/2021
Registration date
25/06/2021
Last edited
14/04/2026
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 of protocol

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 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

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

Primary study designObservational
Study designMulti-centre prospective observational study
Secondary study designCase-control study
Study type Participant information sheet
Scientific titleGenetics Of susceptibility and Mortality In Critical Care (GenOMICC)
Study acronymGenOMICC
Study objectives Current study objectives as of 24/10/2025:

To find the genes that affect why some people become very sick and others don't. If we can find these genes they can help us to develop better treatments for other patients in the future.

_____

Previous study objectives:

What 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
Health condition(s) or problem(s) studiedThis study aims to identify genetic predisposition to specific syndromes of critical illness and outbreaks or exposures of public health interest. This includes susceptibility to life-threatening infections, and susceptibility to adverse outcomes, including mortality, following the onset of organ failure due to sepsis or sterile injury
InterventionCurrent interventions as of 24/10/2025:

Current protocol dated 23/10/2024 (Version 5):
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 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 measure(s)

60-day survival measured using electronic medical records post recruitment

Key secondary outcome measure(s)

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

Completion date31/08/2029

Eligibility

Participant type(s)Patient
Age groupMixed
SexAll
Target sample size at registration40000
Key inclusion criteriaCurrent key inclusion criteria as of 24/10/2025:

The entry criteria below are approved for use in the UK:
23 October 2024 v5.0

Patients will be recruited who:
1. Are deemed, in the view of the treating clinician, to require continuous cardiovascular or respiratory monitoring or any organ support
2. Provide appropriate consent or assent
3. Whose primary reason for admission is one of the following primary diagnoses:
-Critical illness caused by any confirmed or suspected infection OR
-Common non-infectious critical illness syndromes:
--Pancreatitis of any aetiology
--Full thickness burns covering >20% of body surface area
--Rare non-infectious critical illness syndromes:
-Haemophagocytic syndrome
--Still’s disease
--Heat stroke
--Radiation poisoning
-Suspected reactions to therapeutic agents: This includes cell therapies, gene therapy, CAR T-cell therapy, investigational drugs or vaccines in the view of the treating clinician. For example:
--Stevens-Johnson syndrome (SJS) or toxic epidermal necrolysis (TEN), or SJS-TEN overlap to any therapeutic agent
--Cell therapy associated reaction
--Acute hepatitis associated with gene therapy in any age group
-Confirmed or suspected presence of an emerging critical illness syndrome, such as:
--unexplained or idiosyncratic presentations of acute organ injury in the view of the treating clinician
confirmed or suspected exposures of public health interest in the view of the study leadership in consultation with public health agencies. An updated description of these syndromes will be maintained by the central study team on our website.
-Non-infectious critical illness syndromes in children or babies:
--Preterm birth (babies born <32 weeks postmenstrual age)
-Acute seronegative or unexplained hepatitis in children:
--patients under the age of 16 with elevated liver transaminase (ALT > 500 iU/L or AST > 500 iU/L), not due to other diagnoses such as hepatitis viruses A-E, autoimmune hepatitis, or poisoning
-Organ Support. Examples of eligible organ support include, but are not limited to:
--Respiratory: High flow nasal oxygen (HFNO), Continuous positive airway pressure (CPAP), Non-invasive ventilation (NIV), Invasive mechanical ventilation (including following intubation for airway protection)
--Cardiovascular: any vasopressors or inotropes that are given by continuous infusion, extracorporeal membrane oxygenation (ECMO)
--Renal: continuous or intermittent haemofiltration/dialysis/diafiltration where it is used to treat acute disease in a patient who is not normally in receipt of renal support

_____

Previous key inclusion criteria:

1. 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.
Key exclusion criteriaCurrent key exclusion criteria as of 24/10/2025:

Bone marrow transplant recipients

_____

Previous 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.
Date of first enrolment01/01/2016
Date of final enrolment31/08/2029

Locations

Countries of recruitment

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

Study participating centres

Royal Infirmary of Edinburgh
51 Little France Crescent
Edinburgh
EH16 4SA
Scotland
Western General Hospital
Crewe Road
Edinburgh
EH4 2XU
Scotland
St Johns Hospital
Howden W Road
Howden
Livingston
EH54 6PP
Scotland
Royal Hospital for Sick Children
Royal Infirmary of Edinburgh
51 Little France Crescent
Edinburgh
EH16 4SA
Scotland
Airedale NHS Foundation Trust
Skipton Road
Steeton
KEIGHLEY
BD20 6TD
England
Alder Hey Children's NHS Foundation Trust
Eaton Road
Liverpool
L12 2AP
England
Royal Gwent Hospital
Cardiff Road
Newport
NP20 2UB
Wales
The Grange Hospital
Llanyravon
CWNBRAN
NP44 2XJ
Wales
Ashford and St Peters Hospital
Guildford Road
CHERTSEY
KT16 0PZ
England
Queens Hospital
Barking, Havering and Redbridge University Hospitals NHS Trust
Rom Valley Way
ROMFORD
RM7 0AG
England
Barnsley District General Hospital
Barnsley Hospital NHSFT
Gawber Road
BARNSLEY
S75 2EP
England
The Royal London Hospital
Whitechapel Road, Whitechapel
London
E1 1BB
England
Bedford Hospital NHS Trust
King's Place
Britannia Road
BEDFORD
MK42 9DJ
England
Belfast Health and Social Care Trust
Royal Victoria Hospital, 274 Grosvenor Road
Belfast
BT12 6BA
Northern Ireland
Belfast City Hospital
Lisburn Rd
Belfast
BT9 7AB
Northern Ireland
St Bartholomew's Hospital
W Smithfield
London
EC1A 7BE
England
Newham University Hospital
Glen Road
London
E13 8SL
England
Whipps Cross Hospital
Whipps Cross Rd, Leytonstone
London
E11 1NR
England
Mile End Hospital
via A104, Bancroft Rd
London
E1 4DG
England
Ysbyty Gwynedd
Penrhosgarnedd
BANGOR
LL57 2PW
Wales
Glan Clwyd Hospital
Sarn Lan, Bodelwyddan
Denbighshire
LL18 5UJ
Wales
Wrexham Maelor Hospital
Crosenewydd Road
WREXHAM
LL13 7TD
Wales
Birmingham Women’s and Children’s Hospital
Steelhouse Lane
BIRMINGHAM
B4 6NH
England
Blackpool Teaching Hospitals NHS Foundation Trust
Blackpool Victoria Hospital
Whinney Heys Road, Lancashire
BLACKPOOL
FY3 8NR
England
Bolton NHS Foundation Trust,
Minerva Road, Farnworth
Bolton
BL4 0JR
England
Bradford Teaching Hospitals NHS Foundation Trust
Duckworth Lane
BRADFORD
BD9 6R
England
Princess Royal Hospital
Lewes Road
Haywards Heath
RH16 4EX
England
Royal Sussex County Hospital
Eastern Road
Brighton
BN2 5BE
England
ROYAL ALEXANDRA CHILDREN'S HOSPITAL
Royal Sussex County Hospital
Eastern Road
BRIGHTON
Brighton
BN2 5BE
England
Stoke Mandeville Hospital
Buckinghamshire Healthcare NHS Trust
Mandeville Road
AYLESBURY
HP21 8AL
England
Calderdale Royal Hospital
Salterhebble
HALIFAX
HX3 0PW
England
Huddersfield Royal Infirmary
Acre Street
Lindley
HUDDERSFIELD
HD3 3EA
England
Addenbrooke's Hospital
Hills Road
Cambridge
CB2 0QQ
England
University Hospital of Wales and Queen Elizabeth II Wales
Heath Park
CARDIFF
CF14 4XW
Wales
Chelsea and Westminster Hospital,
369 Fulham Road
London
SW10 9NH
England
West Middlesex University Hospital
R&D Office
4thFloor, East wing
West Middlesex University Hospital
Twickenham Road
ISLEWORTH
TW7 6AF
England
Chesterfield Royal Hospital
Chesterfield Road, Calow
Chesterfield
S44 5BL
England
Countess of Chester Hospital
Liverpool Road
Chester
CH2 1UL
England
University Hospital of North Durham
North Road
DURHAM
DH1 5TW
England
County Durham and Darlington NHS Foundation Trust,
Darlington Memorial Hospital
Hollyhurst Road
Darlington
DL3 6HX
England
Croydon University Hospital,
530 London Road
Croydon
CR7 7YE
England
Royal Glamorgan Hospital,
Ynysmaerdy, Llantrisant
Rhondda Cynon Taf
CF72 8XR
Wales
Prince Charles Hospital
Gurnos Road
MERTHYR TYDFIL
CF47 9DT
Wales
Princess of Wales Hospital
Coity Road
BRIDGEND
CF31 1RQ
Wales
Darent Valley Hospital
Darenth Wood Rd
Dartford
DA2 8DA
England
Dorset County Hospital
Williams Avenue
Dorchester
DT1 2JY
England
East and North Hertforshire NHS Trust
Lister Hospital
Coreys Mill Lane
Stevenage
SG1 4AB
England
Macclesfield District General Hospital,
East Cheshire NHS Trust
Victoria Road
Macclesfield
SK10 3BL
England
The William Harvey Hospital
Kennington Road
ASHFORD
TN24 0LZ
England
Queen Elizabeth the Queen Mother Hospital
St Peters Road
KENT
Margate
CT9 4AN
England
Kent and Cantebury Hospital
Ethelbert Road
Kent
Kent
CT1 3NG
England
Royal Blackburn Teaching Hospital
Haslingden road
Lancashire
Blackburn
BB2 3HH
England
ESNEFT Colchester General Hospital,
Turner Road
Essex
Colchester
CO4 5JR
England
ESNEFT Ipswich Hospital
Health Road
Ipswich
IP4 5PD
England
Eastbourne District General Hospital and Conquest Hospital,
Kings Drive, East Sussex
Eastbourne
BN21 2UD
England
Frimley Health NHS Foundation Trust
Pine House
Frimley
Surrey
Camberley
GU16 7UJ
England
Queen Elizabeth Hospital,
Queen Elizabeth Avenue
Sheriff Hill
Gateshead
NE9 6SX
England
Gloucestershire Royal Hospital
Great Western Road
Gloucester
GL1 3NN
England
Aberdeen Royal Infirmary
Foresterhill Road
Aberdeen
AB25 2ZN
Scotland
UCL Great Ormond Street Institute of Child Health (ICH) & Great Ormond Street Hospital (GOSH)
30 Guilford Street
London
WC1N 1EH
England
Great Western Hospital NHS Foundation Trust
Great Western Hospital
Marlborough Road
Wiltshire
Swindon
SN3 6BB
England
Guy's Hospital,
Greta Maze Pond
London
SE1 9RT
England
Guy's and St Thomas' NHS Foundation Trust
Sydney Street
London
SW3 6NP
England
Royal Hampshire County Hospital
Romsey Rd
Winchester
SO22 5DG
England
Basingstoke and North Hampshire Hospital
Aldermaston Road
Hampshire
Basingstoke
RG24 9NA
England
Harrogate District Hospital NHS Foundation Trust
Lancaster Park Road
North Yorkshire
Harrogate
HG2 7SX
England
Homerton University Hospital NHS Foundation Trust
Homerton Row
London
E9 6SR
England
Hull Royal Infirmary,
Anlaby Rd
Hull
HU3 2JZ
England
Withybush Hospital
Fishguard Road
Pembrokeshire
Haverfordwest
SA61 2PZ
Wales
Glangwili General Hospital
Dolgwili Road
CARMARTHEN
SA31 2AF
Wales
Tŷ Geraint Bronglais General Hospital
Caradoc Rd
ABERYSTWYTH
SY23 1ER
Wales
Prince Philip Hospital,
Dafen
Llanelli
SA14 8QF
Wales
St. Mary’s Hospital
Praed Street
London
W2 1NY
England
Charing Cross Hospital
Fulham Palace Road
London
W6 8RF
England
Hammersmith Hospital
150, Du Cane Road
London
W12 0HS
England
St Mary's Hospital,
Parkhurst Road
Isle of Wight
Newport
PO30 5TG
England
James Paget Hospital,
Lowestoft Road
Gorleston-on-Sea
Norfolk
Great Yarmouth
NR31 6LA
England
Kettering General Hospital NHS Foundation Trust,
Rothwell Road
Kettering
Northants
NN16 8UZ
England
Kings College Hospital,
Denmark Hill
London NO COUNTRY SPECIFIED, assuming England
Kings College Hospital, Denmark Hill, London, SE5 9RS
England
Kingston Hospital NHS Foundation Trust,
Galsworthy Road, Surrey
Kingston Upon Thames
KT2 7QB
England
Royal Preston Hospital,
Sharoe Green Lane
Fulwood
Preston
PR2 9HT
England
St James University Hospital
Beckett Street
LEEDS NO COUNTRY SPECIFIED, assuming England
LS9 7TF 
England
Leeds General Infirmary
Great George St
Leeds
LS1 3EX
England
Queen Elizabeth Hospital,
Stadium Road
Woolwich
SE18 4QH
England
University Hospital Lewisham
Lewisham High St
Lewisham
London
SE13 6LH
England
Liverpool Heart And Chest Hospital NHS Foundation Trust,
Galsworthy Road
Liverpool_Chest Upon Thames
Surrey
KT1 7QB
England
The Royal Liverpool University Hospital,
Prescot Street
Liverpool
L7 8XP
England
Aintree University Hospital
Longmoor Lane
Liverpool
L9 7AL
England
Northwick Park Hospital
Watford Road
Harrow
HA1 3UJ
England
Ealing Hospital
Uxbridge Road
Southall
UB1 3HW
England
Maidstone and Tunbridge Wells NHS Trust
Hermitage Lane
Maidstone
Kent
ME16 9QQ
England
Tunbridge Wells Hospital
Tonbridge Road
PEMBURY
TN2 4QJ
England
Manchester University Manchester Royal Infirmary NHS Foundation Trust
North Road
Manchester
M13 9WL
England
Wythenshawe Hospital
Southmoor Road
Manchester
M23 9QZ
England
Royal Manchester Children's Hospital 
North Road
Oxford Road Campus
Manchester
M13 9WL
England
Medway NHS Foundation Trust
Gate Lodge, Maritime Hospital
Windmill Road
Gillingham
Kent
ME7 5NY
England
Basildon University Hospital,
Nethermayne
Basildon
SS16 5NL
England
Southend Hospital
Prittlewell Chase
WESTCLIFF-ON-SEA
SS0 0RY
England
Broomfield Hospital,
Broomfield Hospital, Court Road
Chelmsford
CM1 7ET
England
Pinderfields Hospital,
Mid Yorkshire Hospitals NHS Trust
Aberford Road
Wakefield
WF1 4AL
England
Milton Keynes University Hospital
Standing Way
Eaglestone
Milton Keynes
MK6 5LD
England
Crosshouse Hospital
Kilmarnock Road
KILMARNOCK
KA2 0BE
Scotland
University Hospital Ayr
Dalmellington Rd
AYR
KA6 6DX
Scotland
Borders General Hospital
Huntlyburn Terrace
MELROSE
TD6 9BS
Scotland
Dumfries and Galloway Royal Infirmary
Cargenbridge
DUMFRIES
DG2 8RX
Scotland
Victoria Hospital
Hayfield Road
KIRKCALDY
KY2 5AH
Scotland
Forth Valley Royal Hospital
Stirling Road
LARBERT
FK5 4WR
Scotland
Queen Elizabeth University Hospital
1345 Govan Road
Glasgow
G51 4TF
Scotland
Glasgow Royal Infirmary
10-16 Alexandra Parade
Glasgow
G31 2ER
Scotland
Royal Hospital for Children,
Queen Elizabeth University Hospital
1345 Govan Road
Glasgow
G51 4TF
Scotland
Royal Alexandra Hospital
Corsebar Road
Paisley
PA2 9PN
Scotland
Raigmore Hospital
Old Perth Road
Inverness
IV2 3UJ
Scotland
University Hospital Hairmyres
Eaglesham Road
East Kilbride
G75 8RG
Scotland
University Hospital Wishaw,
50 Netherton Street
Wishaw
ML2 0DP
Scotland
University Hospital Monklands
Monkscourt Avenue
AIRDRIE
ML6 0JS
Scotland
Golden Jubilee National Hospital
Agamemnon Street
Clydebank
Glasgow
G81 4DY
Scotland
Norfolk & Norwich University NHS Foundation Trust,
Colney Lane
Norwich
NR4 7UY
England
Southmead Hospital
Westbury-on-Trym
Bristol
BS10 5NB
England
Cumberland Infirmary
New Town Road
Carlisle
Cumbria
CA2 7HY
England
West Cumberland Hospital
Homewood Road
Whitehaven
CUMBRIA NO COUNTRY SPECIFIED, assuming England
CA28 8JG UK
England
North Middlesex University Hospital NHS Trust
Sterling Way
London
N18 1QX
England
University Hospital of North Tees
Hardwick
STOCKTON ON TEES
TS19 8PE
England
Hinchingbrooke Hospital
Parkway Hinchingbrooke
HUNTINGDON
PE29 6NT
England
Peterborough City Hospital
Bretton gate
PETERBOROUGH
PE3 9GZ
England
Northampton General Hospital NHS Trust
Cliftonville
NORTHAMPTON
NN1 5BD
England
North Devon District Hospital
Raleigh Park
BARNSTAPLE
EX31 4JB
England
Antrim Area Hospital,
Bush Road
Antrim
BT41 2RL
Northern Ireland
Diana, Princess of Wales Hospital
Scartho Road
GRIMSBY
DN33 2BA
England
Scunthorpe General Hospital,
Cliff Gardens
Scunthorpe
DN15 7BH
England
North Tyneside General Hospital,
Rake Lane
North Shields
NE29 8NH
England
Wansbeck General Hospital
Woodhorn Ln
Ashington
NE63 9JJ
England
Northumbria Specialist Emergency Care Hospital
Northumbria Way
Cramlington
NE23 6NZ
England
Nottingham University Hospital Queens
Queens Medical Centre Campus
NOTTINGHAM
NG7 2UH
England
John Radcliffe Hospital
Headley Way
Headington
OXFORD
OX3 9DU
England
Royal Papworth Hospital NHS Foundation Trust
Papworth Road
CAMBRIDGE
CB2 0AY
England
Queen Alexandra Hospital
Portsmouth
COSHAM
PO6 3LY
England
Queen Victoria Hospital
Holtye Rd
East Grinstead
RH19 3DZ
England
Royal Berkshire Hospital
London Road
BERKSHIRE
Reading
RG1 5AN
England
Royal Cornwall Hospital
Treliske
Truro
TR1 3LJ
England
Royal Devon and Exeter Foundation Trust
Barrack Road
EXETER
EX2 5DW
England
Royal Free Hospital NHS Trust,
Pond St
Hampstead
London
NW3 2QG
England
Barnet Hospital
Wellhouse Lane
BARNET
EN5 3DJ
England
Royal Surrey County Hospital,
Egerton Road
Guildford
GU2 7XX
England
Royal United Hospitals Bath NHS Foundation Trust,
Combe Park
Bath
BA1 3NG
England
Salford Royal NHS Foundation Trust
544 Eccles New Road
Salford
MANCHESTER
M6 8HD
England
Salisbury District Hospital
Odstock Road
SALISBURY
SP2 8BJ
England
Sheffield Childrens Hospital
Western Bank
SHEFFIELD
S10 2TH
England
The Royal Hallamshire Hospital
Glossop Road
SHEFFIELD
S10 2JF
England
Northern General Hospital
Herries Rd
Sheffield
S5 7AU
England
King’s Mill Hospital
Mansfield Road
SUTTON-IN-ASHFIELD
NG17 4JL
England
Royal Shrewsbury Hospital
Mytton Oak Road
Shrewsbury
SHROPSHIRE
SY3 8XQ
England
Princess Royal Hospital
Apley Castle
Apley
TELFORD
TF1 6TF
England
Musgrove Park Hospital,
Parkfield Drive
Taunton
SOMERSET
TA1 5DA
England
James Cook University Hospital
Marton road
Middlesbrough
CLEVELAND
TS4 3BW
England
Sunderland Royal Hospital
Kayll Road
SUNDERLAND
SR4 7TP
England
Warwick Hospital,
Lakin road
Warwick
CV34 5BW
England
Craigavon Area Hospital
68 Lurgan Road
PORTADOWN
BT63 5QQ
Northern Ireland
Southport and Ormskirk Hospitals NHS Trust
Southport DGH
Town lane
Kew
SOUTHPORT
PR8 6PN
England
St Georges Hospital NHS Foundation Trust,
Blackshaw Road
TOOTING
London
SW17 0QT
England
Whiston Hospital, Warrington Road, Prescot, L35 5DR
Warrington Road
Prescot
L35 5DR
England
Stepping Hill Hospital
Stockport NHS Foundation
Poplar Grove, Hazel Grove
STOCKPORT
SK2 7JE
England
East Surrey Hospital
Canada Avenue
REDHILL
RH1 5RH
England
Morriston Hospital
Heol Maes Eglwys
MORRISTON
SWANSEA
SA6 6NL
Wales
Tameside General Hospital
Fountain Street
ASHTON-UNDER-LYNE
OL6 9R
England
Ninewells Hospital and Medical School
James Arrott Drive
DUNDEE
DD1 9SY
Scotland
The Christie NHS Foundation Trust,
Wilmslow Road
Manchester
M20 4BX
England
Russells Hall Hospital,
Pensnett Rd
Dudley
DY1 2HQ
England
Royal Victoria Infirmary
Queen Victoria Road
NEWCASTLE UPON TYNE
NE1 4LP
England
Fairfield General Hospital
Rochdale Old Road
BURY
BL9 7TD
England
The Royal Oldham Hospital
Rochdale Road
OLDHAM
OL1 2JH
England
North Manchester General Hospital
Delaunays Road
Crumpsall
MANCHESTER
M8 5RB
England
The Princess Alexandra Hospital
Hamstel Road
Harlow
ESSEX
CM20 1QX
England
The Queen Elizabeth Hospital NHS Foundation Trust
Gayton Road
KING’S LYNN
PE30 4ET
England
Rotherham Hospital
Moorgate Road
ROTHERHAM
S60 2UD
England
The Royal Marsden Hospital
Fulham Road
LONDON
SW3 6JJ
England
New Cross Hospital
The Royal Wolverhampton NHS Trust
The Chesnuts
WOLVERHAMPTON
WV10 0QP
England
Torbay Hospital
Lowes Bridge
TORQUAY
TQ2 7AA
England
Lincoln County Hospital
Greetwell Road
LINCOLN
LN2 5QY
England
Pilgrim Hospital
Sibsey Rd
BOSTON
PE21 9QS
England
University College Hospital
235 Euston Road
LONDON
NW1 2BU
England
National Hospital for Neurology and Neurosurgery
Queen Square
LONDON
WC1N 3BG
England
Royal Derby Hospital
Uttoxeter Road
DERBY
DE22 3NE
England
Queen’s Hospital
Belvedere Road
Burton Upon Trent
STAFFORDSHIRE
DE13 0RB
England
Southampton General Hospital
Tremona Road
Southampton
HAMPSHIRE
SO16 6YD
England
Queen Elizabeth Hospital
Heritage Building
Edgbaston
BIRMINGHAM
B15 2TH
England
Birmingham Heartlands Hospital
Bordesley Green Road
BIRMINGHAM
B9 5SS
England
Good Hope Hospital
Rectory Road
SUTTON
COLDFIELD
B75 7RR
England
Bristol Royal Infirmary
Upper Maudlin Street
BRISTOL
BS2 8HW
England
University Hospital Coventry
Clifford Bridge Road
COVENTRY
CV2 2DX
England
Royal Bournemouth Hospital
Castle Lane East
Bournemouth
BH7 7DW
England
Poole Hospital
Longfleet House
POOLE
BH15 2JB
England
Leicester Royal Infirmary
Infirmary Square
LEICESTER
LE1 5WW
England
Glenfield Hospital
Groby Rd
Leicester
LE3 9QP
England
Leicester Children’s Hospital
Leicester Royal Infirmary
Infirmary Square
LEICESTER
LE1 5WW
England
Royal Lancaster Infirmary,
Ashton Road
LANCASTER
LA1 1RP
England
Furness General Hospital
Dalton Lane
BARROW IN FURNESS
LA14 4LF
England
University Hospitals of North Midlands NHS Trust
Newcastle Road
Stoke-on-Trent
STAFFORDSHIRE
ST4 6QG
England
Derriford Hospital
Derriford Road
PLYMOUTH
PL6 5FP
England
Walsall Manor Hospital
Moat Road
WALSALL
WS2 9PS
England
Warrington Hospital
Lovely Lane
WARRINGTON
WA5 1QG
England
Watford General Hospital NHS Trust
Vicarage Road
WATFORD
WD18 0HB
England
West Suffolk NHS Foundation Trust
Hardwick Lane
Bury St Edmunds
SUFFOLK
IP33 2QZ
England
Worthing Hospital
Lyndhurst Road
WORTHING
BN11 2DH
England
St Richard’s Hospital
Spitalfield Lane
CHICHESTER
PO19 6SE
England
Whittington Health NHS Trust
Magdala Avenue
LONDON
N19 5NF
England
Arrowe Park Hospital
Arrowe Park Road
UPTON
BIRKENHEAD
CH49 5PE
England
Alexandra Hospital
Woodrow Drive
REDDITCH
B98 7UB
England
Worcestershire Royal Hospital,
Charles Hastings Way
Worcester
WR5 1DD
England
Royal Albert Edward Infirmary
The Hawthorns
Wigan Lane
WIGAN
WN1 2NN
England
Hereford County Hospital
Union Walk
HEREFORD
HR1 2ER
England
Yeovil District Hospital
Higher Kingston
YEOVIL
BA21 4AT
England
York Teaching Hospitals NHS Foundation Trust
Wiggington Road
YORK
YO31 8HE
England
Scarborough General Hospital
Woodlands Drive North
SCARBOROUGH
YO12 6QL
England
Leighton Hospital
Leighton
Crewe
CW1 4QJ
England
Ulster Hospital
Upper Newtownards Rd
Dundonald
Belfast
BT16 1RH
Northern Ireland
Bristol Royal Hospital for Children
Upper Maudlin Street
Bristol
BS2 8BJ
England
Antrim Area Hospital
45 Bush Rd
Antrim
BT41 2RL
Northern Ireland
Altnagelvin Area Hospital
Glenshane Road
Londonderry
BT47 6SB
Northern Ireland
Royal Brompton Hospital
Sydney Street
London
SW3 6NP
England
Midland Metropolitan University Hospital
Grove Lane
Smethwick
B66 2QT
England
Doncaster & Bassetlaw Hospitals
Doncaster Royal Infirmary
Thorne Road
Doncaster
DN2 5LT
England
Liverpool Women's NHS Foundation Trust
Liverpool Womens Hospital
Crown Street
Liverpool
L8 7SS
England
Hillingdon Hospital
Hillingdon Hospital
Pield Heath Road
Uxbridge
UB8 3NN
England
George Eliot Hospital
Lewis House
College Street
Nuneaton
CV10 7DJ
England
Victoria Maternity Unit
Hayfield Road
Kirkcaldy
KY2 5AH
Scotland
The Walton Centre NHS Foundation Trust
Lower Lane
Fazakerley
Liverpool
L9 7LJ
England
The Princess Royal Maternity Unit
16 Alexandra Parade
Glasgow
G31 2ER
Scotland
South Tyneside District General Hospital
Harton Lane
South Shields
NE34 0PL
England
Royal Stoke University Hospital
Newcastle Road
Stoke-on-trent
ST4 6QG
England
Nottingham University Hospitals NHS Trust - Queen's Medical Centre Campus
Nottingham University Hospital
Derby Road
Nottingham
NG7 2UH
England
Harefield Hospital
Hill End Road
Harefield
Uxbridge
UB9 6JH
England
The Queen Elizabeth Hospital, King's Lynn, NHS Foundation Trust
Queen Elizabeth Hospital
Gayton Road
King's Lynn
PE30 4ET
England
Queen Elizabeth Hospital
Woolwich Stadium Road
Woolwich
London
SE18 4QH
England
Epsom Hospital
Epsom General Hospital
Dorking Road
Epsom
KT18 7EG
England
St Helier Hospital
Wrythe Lane
Carshalton
SM5 1AA
England

Results and Publications

Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryStored in publicly available repository
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?
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
Participant information sheet Participant information sheet 11/11/2025 11/11/2025 No Yes
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
Study website Study website 11/11/2025 11/11/2025 No Yes

Editorial Notes

14/04/2026: The study participating centres were updated.
24/10/2025: The following changes were made to the trial record:
1. The study objectives were changed.
2. The condition was changed from "Genetics of susceptibility and mortality in life-threatening infection" to "This study aims to identify genetic predisposition to specific syndromes of critical illness and outbreaks or exposures of public health interest. This includes susceptibility to life-threatening infections, and susceptibility to adverse outcomes, including mortality, following the onset of organ failure due to sepsis or sterile injury".
3. The interventions were changed.
4. The key inclusion criteria were changed.
5. The key exclusion criteria were changed.
6. The study participating centres were updated.
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.