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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

Genetics Of susceptibility and Mortality In Critical Care (GenOMICC)

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN16993428
Enrollment
100000
Registered
2021-06-25
Start date
2016-01-01
Completion date
Unknown
Last updated
2026-05-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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 Infections and Infestations

Interventions

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
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 h

Sponsors

Accord (United Kingdom)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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 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. B

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
60-day survival measured using electronic medical records post recruitment

Secondary

MeasureTime frame
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

Countries

England, Northern Ireland, Scotland, United Kingdom, Wales

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: May 29, 2026