An observational study in Viral Infections, Bacterial Infections and Fungal Infections, sponsored by The University of Hong Kong. Recruiting at 1 site in China. Open to participants aged 18 Years to 100 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-12.
Sponsored by The University of Hong Kong · Observational
Develop an emergency PanorOmics Wide Association Study (ePWAS) for the early, rapid biological and pathophysiological characterisation of known and novel Infectious Diseases in adult patients presenting to emergency departments with suspected, acute, community-acquired respiratory infectious disease (scaRID).
Phase 1
Introduction
Pandemic Preparedness
The COVID-19 pandemic has affected over 220 million people, claimed over 450 000 lives and invoked variable responses across the world. Delays in acquiring quality clinical and scientific material on the transmissibility, clinical nature, outcomes and lethality of novel and known infectious diseases (ID) translate into healthcare inefficiencies, societal and economic stress, and increased morbidity and mortality. Regions with greater success in the fight against COVID-19 were well prepared before the pandemic.
Pathogens
The pathogens most likely to cause annual epidemics and pandemics are respiratory viruses. In Asia, viral infections account for 30-40% of sepsis cases. Each year there are 100 million cases of viral community-acquired pneumonia (CAP) of which 60% progress to sepsis. These viruses cause host-mediated, inflammatory, immune responses which progresses through three phases: preliminary regulated inflammation; intermediate dysregulated proinflammation; and late dysregulated hypoinflammation.
Clinical Spectrum
RID is a heterogeneous population of patients. This complex spectrum of heterogeneity extends throughout the underlying molecular biology and pathophysiology from genome to phenome. It includes significant individual variation in regulated and dysregulated systemic inflammatory host responses to infection in the presence and absence of organ dysfunction. Critical illness from any ID involves both host susceptibility to the pathogen and host propensity to develop dysregulated inflammation and organ failure (e.g. pulmonary inflammation and/or acute kidney injury).
PanorOmics-Wide Association Studies
In the five years prior to the COVID-19 pandemic, the United Kingdom's Genetics Of Mortality In Critical Care (GenOMICC) study recruited patients with a spectrum of critical illness syndromes (e.g. influenza, sepsis, and emerging infections) to better understand host mechanisms that lead to life-threatening outcomes. As a result, the GenOMICC investigators, along with collaborators from Spain and Italy, were well placed to perform genomic-association studies on critically ill COVID-19 patients and to make recommendations for future studies.
An integrated panorOmics approach has the potential to uncover causal associations and linkages across the entire spectrum of host biology including genomics, epigenomics, transcriptomics, proteomics, metabolomics and lipidomics, through to clinical phenotype. However, panorOmics as a discipline faces the same challenges as Genome-wide association studies (GWAS), only more so. Although GWAS correlate genomic loci with complex signatures and traits, efficient detection is hindered by false positives, linkage disequilibrium, and high expense. True causal variations and real underlying associations require multiple filters if they are to be detected.
The investigators propose to develop an ED-based system of dynamic studies on blood and saliva samples taken from patients at an early stage of ID. Early stage refers to a process in the patient pathway that precedes most patient recruitment in other studies i.e. on wards or ICU. The two primary objectives are a) to develop an ED-ID biobank; and b) to undertake preliminary discovery and targeted research for the discovery of novel diagnostics, prognostics and therapeutics.
The investigators will define early multiOmics signatures of RID and identify relationships to known and novel ID. Few studies have been published on the integrated panorOmics of COVID-19, and few if any address the early phases of illness or differentiating features in comparison to other respiratory illnesses.
In disease stratified, case-control matched comparisons of adult patients with scaRID attending EDs, what panorOmic signatures differentiate low risk from high risk across a 30-day WHO-Clinical Progression Scale (WHO-CPS)?
For the purpose of this study, scaRID is defined as:
One or more relevant symptoms:
PanorOmic associations will be derived from liquid biopsy samples, including whole blood, plasma, serum, white cell pellet, red cell effluent, salivary supernatant, and salivary cells. Liquid biopsy biomarkers include genomic, transcriptomic, proteomic, metabolomic, lipidomic and haematological contents.
Hypothesis The investigators hypothesise that in propensity-matched, adult patients with pathogen-specific and disease specific RID (e.g. SARS-CoV-2, Influenza A) there are significant differences in panorOmic signatures that delineate host susceptibility and host response for mild to severe disease.
Objectives
The purpose of this proposal is to develop an emergency PanorOmics Wide Association Study (ePWAS) biobank for the early, rapid biological and pathophysiological characterisation of scaRID. More specifically, in adult patients presenting to EDs with scaRID and within 10 days of symptom onset, we aim:
The goals of the biobank and the ePWAS-RID repository are:
656 studies on the registry are indexed under Virus Diseases; 85 are open to participants now.
This study's planned enrollment of 2,000 is above the median of 442 across 167 observational studies indexed under Virus Diseases.
Browse Virus Diseases studies →The University of Hong Kong is the lead sponsor of 1,292 studies on the registry; 348 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Suspected, acute, community-acquired, respiratory, infectious disease presenting to emergency department with symptom onset \<8 days and reported fever or chills or aural temperature >37.5°C
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Patients eligible for enrolment include:
With reference to previous inclusion criteria are:
Note: scaRID is defined according to ALL three criteria:
Probable respiratory infection - According to any ONE of:
Control subjects will be drawn from two groups:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
After a transplant from a donor, the donor’s immune cells attack the recipient’s body, often the skin, gut or liver.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GVHD (graft-versus-host disease)
After a transplant from a donor, the donor’s immune cells attack the recipient’s body, often the skin, gut or liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Viral infection subjects presenting within 8 days from symptom onset will have at least one whole blood and saliva drawn a) in the emergency department (if available) or hospital within 8 days of the onset of symptoms; and if they agree
Diagnostic Test: Biomarker blood draw and saliva collection
Bacterial infection subjects presenting within 8 days from symptom onset will have at least one whole blood and saliva drawn a) in the emergency department (if available) or hospital within 8 days of the onset of symptoms; and if they agree, a further two samples at b) 24 hours +/- 6 hours from symptom onset (if available); and c) 48 hours +/- 6 hours from symptom onset (if available).
Diagnostic Test: Biomarker blood draw and saliva collection
Viral-viral co-infection subjects presenting within 8 days from symptom onset will have at least one whole blood and saliva drawn a) in the emergency department (if available) or hospital within 8 days of the onset of symptoms; and if they agree, a further two samples at b) 24 hours +/- 6 hours from symptom onset (if available); and c) 48 hours +/- 6 hours from symptom onset (if available).
Diagnostic Test: Biomarker blood draw and saliva collection
Bacterial-Viral co-infection subjects presenting within 8 days from symptom onset will have at least one whole blood and saliva drawn a) in the emergency department (if available) or hospital within 8 days of the onset of symptoms; and if they agree, a further two samples at b) 24 hours +/- 6 hours from symptom onset (if available); and c) 48 hours +/- 6 hours from symptom onset (if available).
Diagnostic Test: Biomarker blood draw and saliva collection
Bacterial-Viral co-infection subjects presenting within 8 days from symptom onset will have at least one whole blood and saliva drawn a) in the emergency department (if available) or hospital within 8 days of the onset of symptoms; and if they agree, a further two samples at b) 24 hours +/- 6 hours from symptom onset (if available); and c) 48 hours +/- 6 hours from symptom onset (if available).
Diagnostic Test: Biomarker blood draw and saliva collection
Infection of uncertain origin subjects presenting within 8 days from symptom onset will have at least one whole blood and saliva drawn a) in the emergency department (if available) or hospital within 8 days of the onset of symptoms; and if they agree, a further two samples at b) 24 hours +/- 6 hours from symptom onset (if available); and c) 48 hours +/- 6 hours from symptom onset (if available).
Diagnostic Test: Biomarker blood draw and saliva collection
Control group subjects, if they agree, will have at least one whole blood and saliva drawn a) in the emergency department (if available) or hospital within 8 days of the onset of symptoms (if applicable); and if they agree, a further two samples at b) 24 hours +/- 6 hours from symptom onset (if applicable); and c) 48 hours +/- 6 hours from symptom onset (if applicable).
Diagnostic Test: Biomarker blood draw and saliva collection
Three peripheral 10 - 20mL blood sample (if available) Three 1 - 5mL salivary samples (if available)
WHO-CPS
Differentiation of WHO-CPS \>6 from WHO-CPS ≤6
Time frame: Up to 30 days
Mortality
Mortality is defined as all-cause, Binary: Yes or No
Time frame: Up to 30 days
Mortality
Mortality is defined as all-cause, Binary: Yes or No
Time frame: one year
Plan to share: No
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