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
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
Scientific
Roslin Institute
University of Edinburgh
Easter Bush
Midlothian
Edinburgh
EH25 9RG
United Kingdom
| 0000-0001-5258-793X | |
| Phone | +44 (0)300 365 7660 |
| genomicc@roslin.ed.ac.uk |
Study information
| Primary study design | Observational |
|---|---|
| Study design | Multi-centre prospective observational study |
| Secondary study design | Case-control study |
| Study type | Participant information sheet |
| Scientific title | Genetics Of susceptibility and Mortality In Critical Care (GenOMICC) |
| Study acronym | GenOMICC |
| 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) studied | 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 |
| Intervention | Current 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 type | Other |
| 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 date | 31/08/2029 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Sex | All |
| Target sample size at registration | 40000 |
| Key inclusion criteria | Current 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 criteria | Current 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 enrolment | 01/01/2016 |
| Date of final enrolment | 31/08/2029 |
Locations
Countries of recruitment
- United Kingdom
- England
- Northern Ireland
- Scotland
- Wales
- Canada
- Ireland
Study participating centres
Edinburgh
EH16 4SA
Scotland
Edinburgh
EH4 2XU
Scotland
Howden
Livingston
EH54 6PP
Scotland
51 Little France Crescent
Edinburgh
EH16 4SA
Scotland
Steeton
KEIGHLEY
BD20 6TD
England
Liverpool
L12 2AP
England
Newport
NP20 2UB
Wales
CWNBRAN
NP44 2XJ
Wales
CHERTSEY
KT16 0PZ
England
Rom Valley Way
ROMFORD
RM7 0AG
England
Gawber Road
BARNSLEY
S75 2EP
England
London
E1 1BB
England
Britannia Road
BEDFORD
MK42 9DJ
England
Belfast
BT12 6BA
Northern Ireland
Belfast
BT9 7AB
Northern Ireland
London
EC1A 7BE
England
London
E13 8SL
England
London
E11 1NR
England
London
E1 4DG
England
BANGOR
LL57 2PW
Wales
Denbighshire
LL18 5UJ
Wales
WREXHAM
LL13 7TD
Wales
BIRMINGHAM
B4 6NH
England
Whinney Heys Road, Lancashire
BLACKPOOL
FY3 8NR
England
Bolton
BL4 0JR
England
BRADFORD
BD9 6R
England
Haywards Heath
RH16 4EX
England
Brighton
BN2 5BE
England
Eastern Road
BRIGHTON
Brighton
BN2 5BE
England
Mandeville Road
AYLESBURY
HP21 8AL
England
HALIFAX
HX3 0PW
England
Lindley
HUDDERSFIELD
HD3 3EA
England
Cambridge
CB2 0QQ
England
CARDIFF
CF14 4XW
Wales
London
SW10 9NH
England
4thFloor, East wing
West Middlesex University Hospital
Twickenham Road
ISLEWORTH
TW7 6AF
England
Chesterfield
S44 5BL
England
Chester
CH2 1UL
England
DURHAM
DH1 5TW
England
Hollyhurst Road
Darlington
DL3 6HX
England
Croydon
CR7 7YE
England
Rhondda Cynon Taf
CF72 8XR
Wales
MERTHYR TYDFIL
CF47 9DT
Wales
BRIDGEND
CF31 1RQ
Wales
Dartford
DA2 8DA
England
Dorchester
DT1 2JY
England
Coreys Mill Lane
Stevenage
SG1 4AB
England
Victoria Road
Macclesfield
SK10 3BL
England
ASHFORD
TN24 0LZ
England
KENT
Margate
CT9 4AN
England
Kent
Kent
CT1 3NG
England
Lancashire
Blackburn
BB2 3HH
England
Essex
Colchester
CO4 5JR
England
Ipswich
IP4 5PD
England
Eastbourne
BN21 2UD
England
Frimley
Surrey
Camberley
GU16 7UJ
England
Sheriff Hill
Gateshead
NE9 6SX
England
Gloucester
GL1 3NN
England
Aberdeen
AB25 2ZN
Scotland
London
WC1N 1EH
England
Marlborough Road
Wiltshire
Swindon
SN3 6BB
England
London
SE1 9RT
England
London
SW3 6NP
England
Winchester
SO22 5DG
England
Hampshire
Basingstoke
RG24 9NA
England
North Yorkshire
Harrogate
HG2 7SX
England
London
E9 6SR
England
Hull
HU3 2JZ
England
Pembrokeshire
Haverfordwest
SA61 2PZ
Wales
CARMARTHEN
SA31 2AF
Wales
ABERYSTWYTH
SY23 1ER
Wales
Llanelli
SA14 8QF
Wales
London
W2 1NY
England
London
W6 8RF
England
London
W12 0HS
England
Isle of Wight
Newport
PO30 5TG
England
Gorleston-on-Sea
Norfolk
Great Yarmouth
NR31 6LA
England
Kettering
Northants
NN16 8UZ
England
London NO COUNTRY SPECIFIED, assuming England
Kings College Hospital, Denmark Hill, London, SE5 9RS
England
Kingston Upon Thames
KT2 7QB
England
Fulwood
Preston
PR2 9HT
England
LEEDS NO COUNTRY SPECIFIED, assuming England
LS9 7TF
England
Leeds
LS1 3EX
England
Woolwich
SE18 4QH
England
Lewisham
London
SE13 6LH
England
Liverpool_Chest Upon Thames
Surrey
KT1 7QB
England
Liverpool
L7 8XP
England
Liverpool
L9 7AL
England
Harrow
HA1 3UJ
England
Southall
UB1 3HW
England
Maidstone
Kent
ME16 9QQ
England
PEMBURY
TN2 4QJ
England
Manchester
M13 9WL
England
Manchester
M23 9QZ
England
Oxford Road Campus
Manchester
M13 9WL
England
Windmill Road
Gillingham
Kent
ME7 5NY
England
Basildon
SS16 5NL
England
WESTCLIFF-ON-SEA
SS0 0RY
England
Chelmsford
CM1 7ET
England
Aberford Road
Wakefield
WF1 4AL
England
Eaglestone
Milton Keynes
MK6 5LD
England
KILMARNOCK
KA2 0BE
Scotland
AYR
KA6 6DX
Scotland
MELROSE
TD6 9BS
Scotland
DUMFRIES
DG2 8RX
Scotland
KIRKCALDY
KY2 5AH
Scotland
LARBERT
FK5 4WR
Scotland
Glasgow
G51 4TF
Scotland
Glasgow
G31 2ER
Scotland
1345 Govan Road
Glasgow
G51 4TF
Scotland
Paisley
PA2 9PN
Scotland
Inverness
IV2 3UJ
Scotland
East Kilbride
G75 8RG
Scotland
Wishaw
ML2 0DP
Scotland
AIRDRIE
ML6 0JS
Scotland
Clydebank
Glasgow
G81 4DY
Scotland
Norwich
NR4 7UY
England
Bristol
BS10 5NB
England
Carlisle
Cumbria
CA2 7HY
England
Whitehaven
CUMBRIA NO COUNTRY SPECIFIED, assuming England
CA28 8JG UK
England
London
N18 1QX
England
STOCKTON ON TEES
TS19 8PE
England
HUNTINGDON
PE29 6NT
England
PETERBOROUGH
PE3 9GZ
England
NORTHAMPTON
NN1 5BD
England
BARNSTAPLE
EX31 4JB
England
Antrim
BT41 2RL
Northern Ireland
GRIMSBY
DN33 2BA
England
Scunthorpe
DN15 7BH
England
North Shields
NE29 8NH
England
Ashington
NE63 9JJ
England
Cramlington
NE23 6NZ
England
NOTTINGHAM
NG7 2UH
England
Headington
OXFORD
OX3 9DU
England
CAMBRIDGE
CB2 0AY
England
COSHAM
PO6 3LY
England
East Grinstead
RH19 3DZ
England
BERKSHIRE
Reading
RG1 5AN
England
Truro
TR1 3LJ
England
EXETER
EX2 5DW
England
Hampstead
London
NW3 2QG
England
BARNET
EN5 3DJ
England
Guildford
GU2 7XX
England
Bath
BA1 3NG
England
Salford
MANCHESTER
M6 8HD
England
SALISBURY
SP2 8BJ
England
SHEFFIELD
S10 2TH
England
SHEFFIELD
S10 2JF
England
Sheffield
S5 7AU
England
SUTTON-IN-ASHFIELD
NG17 4JL
England
Shrewsbury
SHROPSHIRE
SY3 8XQ
England
Apley
TELFORD
TF1 6TF
England
Taunton
SOMERSET
TA1 5DA
England
Middlesbrough
CLEVELAND
TS4 3BW
England
SUNDERLAND
SR4 7TP
England
Warwick
CV34 5BW
England
PORTADOWN
BT63 5QQ
Northern Ireland
Town lane
Kew
SOUTHPORT
PR8 6PN
England
TOOTING
London
SW17 0QT
England
Prescot
L35 5DR
England
Poplar Grove, Hazel Grove
STOCKPORT
SK2 7JE
England
REDHILL
RH1 5RH
England
MORRISTON
SWANSEA
SA6 6NL
Wales
ASHTON-UNDER-LYNE
OL6 9R
England
DUNDEE
DD1 9SY
Scotland
Manchester
M20 4BX
England
Dudley
DY1 2HQ
England
NEWCASTLE UPON TYNE
NE1 4LP
England
BURY
BL9 7TD
England
OLDHAM
OL1 2JH
England
Crumpsall
MANCHESTER
M8 5RB
England
Harlow
ESSEX
CM20 1QX
England
KING’S LYNN
PE30 4ET
England
ROTHERHAM
S60 2UD
England
LONDON
SW3 6JJ
England
The Chesnuts
WOLVERHAMPTON
WV10 0QP
England
TORQUAY
TQ2 7AA
England
LINCOLN
LN2 5QY
England
BOSTON
PE21 9QS
England
LONDON
NW1 2BU
England
LONDON
WC1N 3BG
England
DERBY
DE22 3NE
England
Burton Upon Trent
STAFFORDSHIRE
DE13 0RB
England
Southampton
HAMPSHIRE
SO16 6YD
England
Edgbaston
BIRMINGHAM
B15 2TH
England
BIRMINGHAM
B9 5SS
England
SUTTON
COLDFIELD
B75 7RR
England
BRISTOL
BS2 8HW
England
COVENTRY
CV2 2DX
England
Bournemouth
BH7 7DW
England
POOLE
BH15 2JB
England
LEICESTER
LE1 5WW
England
Leicester
LE3 9QP
England
Infirmary Square
LEICESTER
LE1 5WW
England
LANCASTER
LA1 1RP
England
BARROW IN FURNESS
LA14 4LF
England
Stoke-on-Trent
STAFFORDSHIRE
ST4 6QG
England
PLYMOUTH
PL6 5FP
England
WALSALL
WS2 9PS
England
WARRINGTON
WA5 1QG
England
WATFORD
WD18 0HB
England
Bury St Edmunds
SUFFOLK
IP33 2QZ
England
WORTHING
BN11 2DH
England
CHICHESTER
PO19 6SE
England
LONDON
N19 5NF
England
UPTON
BIRKENHEAD
CH49 5PE
England
REDDITCH
B98 7UB
England
Worcester
WR5 1DD
England
Wigan Lane
WIGAN
WN1 2NN
England
HEREFORD
HR1 2ER
England
YEOVIL
BA21 4AT
England
YORK
YO31 8HE
England
SCARBOROUGH
YO12 6QL
England
Crewe
CW1 4QJ
England
Dundonald
Belfast
BT16 1RH
Northern Ireland
Bristol
BS2 8BJ
England
Antrim
BT41 2RL
Northern Ireland
Londonderry
BT47 6SB
Northern Ireland
London
SW3 6NP
England
Smethwick
B66 2QT
England
Thorne Road
Doncaster
DN2 5LT
England
Crown Street
Liverpool
L8 7SS
England
Pield Heath Road
Uxbridge
UB8 3NN
England
College Street
Nuneaton
CV10 7DJ
England
Kirkcaldy
KY2 5AH
Scotland
Fazakerley
Liverpool
L9 7LJ
England
Glasgow
G31 2ER
Scotland
South Shields
NE34 0PL
England
Stoke-on-trent
ST4 6QG
England
Derby Road
Nottingham
NG7 2UH
England
Harefield
Uxbridge
UB9 6JH
England
Gayton Road
King's Lynn
PE30 4ET
England
Woolwich
London
SE18 4QH
England
Dorking Road
Epsom
KT18 7EG
England
Carshalton
SM5 1AA
England
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Stored in publicly available repository |
| IPD sharing plan | The 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.