Who do I recruit?
Please aim to recruit every COVID-19 patient who is invasively ventilated (intubated).
We focus on the youngest and sickest patients first. If you need to prioritise, please start with the youngest patients who are ventilated in your ICU.
If you have time and capacity, we also include a broader range of patients in critical care:
- Our aim is to capture ICU and HDU patients. During the COVID-19 outbreak these patients will be cared for in unusual areas. For this reason, and to enable international comparisons where terms like "ICU" and "HDU" are applied differently, we settled on the catch-all description "requires continuous cardiorespiratory monitoring". Treatment with CPAP or NIV does not always require continuous monitoring so that doesn't meet our criteria on its own.
- We added "or invasive mechanical ventilation" to the criteria because we don't want to miss anyone who is intubated, although of course clinicians will recognise that continuous monitoring is always required in intubated patients.
- Patients not admitted to critical care are not included, even if they are desperately sick
- If a patient meets the inclusion criteria they remain eligible for recruitment for the rest of their lives, even after being transferred out of ICU.
The entry criteria below are approved for use in the UK:
27th July 2020 v2.4
Inclusion criteria are stratified to facilitate recruitment under conditions in which resources are limited (Dunning et al. 2014). Lower tiers include syndromes with a high probability of genetic susceptibility and will be prioritised in resource-limited settings. Higher tiers describe less-specific syndromes with a focus on mortality.
Patients will be recruited who:
Are deemed, in the view of the treating physician, to require continuous cardiovascular or respiratory monitoring or invasive mechanical ventilation,
AND provide appropriate consent or assent,
AND present with one of the following primary diagnoses:
Group 1: specific infectious syndromes in highly-selected patients
COVID-19. Confirmed or suspected COVID-19.
Influenza. Confirmed or suspected infection with influenza virus.
Secondary pneumonia. Acute pneumonia complicating confirmed infection with influenza virus.
Dengue. Confirmed or suspected infection with dengue virus.
RSV. Confirmed infection with respiratory syncytial virus.
Emerging infections. Confirmed or suspected infection with an emerging infection (see below).
Group 2: specific non-infectious critical illness syndromes
Burns. Full thickness burns covering > 20% of body surface area.
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:
confirmed or suspected multisystem inflammatory syndrome temporally associated with COVID-19
acute disease associated with inhalation of noxious substances or vapours, such as "vaping"
acute disease associated with CAR T-cell therapy
Group 3: extreme critical illness
Extra-corporeal life support. Requirement for continuous veno-venous extra-corporeal support for respiratory failure of any aetiology.
Group 4: common/nonspecific critical illness syndromes
Cellulitis. Soft tissue infections causing systemic sepsis.
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.
Pancreatitis. Pancreatitis of any aetiology.
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.
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.
The following additional groups of people will be eligible for recruitment:
Patients recruited into participating ethically-approved clinical studies (listed here: https://genomicc.org/uk/trials) will be recruited to GenOMICC. This route of inclusion in GenOMICC will be available to research studies of conditions related to the above inclusion criteria, including, but not limited to, the ACCORD-2 and RECOVERY-PK studies of therapy for COVID-19.
Control groups. Although some comparison groups can be obtained from population genetic studies and from within the critically-ill population, additional controls may increase discovery power in this study for variants determining susceptibility to severe disease. Volunteers from the general population will be eligible to act as controls if they have no prior history of critical illness.