Single Cell Sequencing TechnologyNCT06846645
Host Response to Infection by Direct Analysis of Leukocyte Single Cell-type Gene Expression/transcript Abundance, Direct LS-TA. a Prospective Study Will Evaluate the Performance of Direct LS-TA in Triage Febrile Patients Into Major Categories of Infections: Viral, Bacterial or Active Tuberculosis.
An observational study of Single Cell Sequencing Technology and Gene Expression Profiling, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
Febrile illness is a common condition and it is crucial to have an early triage of patients according to various aetiologies to enable appropriate treatment. Currently, most screening/diagnostic tests target the detection of pathogens, while only a few assays aim to understand the host response, and they are mostly… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Single Cell Sequencing Technology, Gene Expression Profiling, Gene Expression
- How many people
- 200 participants
- Where
- 1 siteHong Kong
- Study dates
- Feb 2025to Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with fever due to infections which are later clinically diagnosed as viral infection, bacterial infection or active tuberculosis.
Who may be able to join
- Adult patients with fever of acute onset which is defined by a raised body temperature.
- Patient should understand Chinese word to give informed consent.
Who cannot join
- Patients with a history of any immunodeficiency or immunocompromised condition. Patients received steriod or other immunotherapy.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site
Dept of Chemical Pathology, Chinese University of Hong Kong
Hong Kong
Tang, 852 35053330, nelsontang@cuhk.edu.hk
About this study
Official title: Peripheral Blood Single Cell-type Expression Profile of Interferon-stimulated and Other Biomarker Genes for Triage of Febrile Patients
Febrile illness is a common condition and it is crucial to have an early triage of patients according to various aetiologies to enable appropriate treatment. Currently, most screening/diagnostic tests target the detection of pathogens, while only a few assays aim to understand the host response, and they are mostly based on a measurement of serum proteins (e.g. CRP or procalcitonin).
Recently, blood transcriptome has been explored to differentiate bacterial and viral infections. However, gene expression in blood represents a composite score of gene expression of all the component cell-types present in the sample. Here, we propose to develop a rapid test that can determine gene expressions of a specified single cell type in peripheral blood (e.g., monocytes or granulocytes) as a host response biomarker to differentiate three major categories of infections that are bacterial, viral, and tuberculosis The assay is called Direct Leukocyte Single cell-type transcript abundance (TA) assay (DIRECT LS-TA) as it can directly determine the gene expression of a specified single cell-type among various other leukocyte populations directly in a peripheral blood sample. Such results signify the nature of host response according to 3 or more axes (Type I or Type II interferon signaling response or pro-inflammatory cytokine signaling) And it can be used to indicate the type of underlying infection (viral, bacterial, or active tuberculosis).
Read the detailed description
DIRECT LS-TA is a ratio-based biomarker (RBB) for blood gene expression analysis which can be performed in commonly available equipments (e.g. qPCR or digital PCR machines). Using the ratio of TA of prior defined numerator gene and denominator gene, this RBB can quantify gene expression of the specified constitutional single cell-type (e.g. monocytes and granulocytes) inside a cell-mixture sample of Whole blood. DIRECT LS-TA was a method pioneered by the PI [Tang 2017, https://patents.google.com/patent/US9589099B2/]. And it has been developed for quantification of early B cell response after vaccination [DOI: 10.3390/genes12070971]. Recently, the method is used to develop host response biomarkers after infection to differentiate the type of pathogens (such as viral, bacterial or active tuberculosis). Numerator and denominator genes have been identified by using public gene expression datasets for monocytes and granulocytes. Diagnostic performance was good using these public data. Therefore, these RBBs will be applied in the prospective study to evaluate and compare their diagnostic (triage) performance of febrile patients into different pathogen etiologies.
Comparing to other methods to obtain single cell-type gene expression data, DIRECT LS-TA has many advantages The conventional (gold standard) approach is to quantify gene expression in a sample of purified single cell-type from peripheral blood but it is very labour intensive procedure. Recent single-cell RNA sequencing can also provide gene expression data for every individual cell in a sample, but it is slow and very costly. DIRECT LS-TA provides the unique technique to quantify single cell-type gene expression in blood samples without the need to isolate the targeted cell-type. It has been used to differentiate the type of host response in fever patients into 3 major axes (Type I or Type II interferon signaling response or pro-inflammatory cytokine signaling) which correspond to the nature of underlying infection aetiologies (viral infection, active tuberculosis and bacterial infection).
See preprint DOI: 10.1101/2025.01.27.634977. and patents in B cells : https://patents.google.com/patent/WO2022089426A1/ Monocytes: https://patents.google.com/patent/WO2023109365A1/ Granulocytes : https://patents.google.com/patent/GB202400180D0/
- Conditions
- Single Cell Sequencing Technology, Gene Expression Profiling, Gene Expression, Infection, Viral Diseases, Bacterial Diseases
- Being tested
- No intervention
- Keywords
- host response, transcriptome, single cell-type gene expression, single cell RNA, triage, fever, febrile patient, Direct LS-TA
- Medical subject headings
- Infections, Virus Diseases, Bacterial Infections, Latent Tuberculosis, Fever
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
Patients will receive clinical treatment with no special intervention in this observational study. There is no difference in term of treatment of patients. It only involves one additional blood sampling early after admission.
| Study group | Role | What they receive |
|---|---|---|
| Bacterial infection group | A prospective sample of adult patients who later confirmed to have fever due to bacterial infection by positive culture results. Receives: Other: No intervention | |
| Viral infection group | A prospective sample of adult patients who later confirmed to have fever due to viral infection by positive pathogen diagnostic results. Receives: Other: No intervention | |
| Active tuberculosis group | A prospective sample of adult patients who later confirmed to have fever due to active tuberculosis by clinical diagnosis and/or positive pathogen results. Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Viral host response Direct LS-TA in monocytes (Type I interferon response)
Direct LS-TA is a kind of RBB that can be readily quantified by qPCR or dPCR of a pair of genes, the RBB numerator gene and the RBB denominator gene. The biomarker is the ratio of the 2 genes. Single cell-type: Monocyte. RBB numerator gene: IFI27 or IFI44L. RBB denominator gene: PSAP, CTSS or CPVL.
The various RBB (e.g. IFI27/PSAP and IFI44L/PSAP ratios) will be compared in terms of their sensitivity/specificity of diagnostic performance in the samples from infection groups. AUC of ROC analysis will be performed where appropriate.
Measured: first collected sample within the first week after admission
Viral host response Direct LS-TA in granulocytes (Type I interferon response)
Direct LS-TA is a kind of RBB that can be readily quantified by qPCR or dPCR of a pair of genes, the RBB numerator gene and the RBB denominator gene. The biomarker is the ratio of the 2 genes. Single cell-type: Granulocyte. RBB numerator gene: RSAD2 or IFIT1.
RBB denominator gene: SAT1 or SRGN. The various RBB will be compared in terms of their sensitivity/specificity of diagnostic performance in the infection groups. AUC of ROC analysis will be performed where appropriate.
Measured: first collected sample within the first week after admission
Bacterial infection host response Direct LS-TA in monocytes (pro-inflammatory response)
Direct LS-TA is a kind of RBB that can be readily quantified by qPCR or digital PCR (dPCR) of a pair of genes, the RBB numerator gene and the RBB denominator gene. The biomarker is the ratio of the 2 genes. Single cell-type: Monocyte. RBB numerator gene: VNN1 or NLRC4. RBB denominator gene: PSAP, CTSS or CPVL. The various RBBs will be compared in terms of their sensitivity/specificity of diagnostic performance in the infection groups. AUC of ROC analysis will be performed where appropriate.
Measured: first collected sample within the first week after admission
Bacterial infection host response Direct LS-TA in granulocytes (pro-inflammatory response)
Direct LS-TA is a kind of RBB that can be readily quantified by qPCR or dPCR of a pair of genes, the RBB numerator gene and the RBB denominator gene. The biomarker is the ratio of the 2 genes. Single cell-type: Granulocyte. RBB numerator gene: ALPL, ANXA3 or ARG1.
RBB denominator gene: SAT1 or SRGN. The various RBB will be compared in terms of their sensitivity/specificity of diagnostic performance in the infection groups. AUC of ROC analysis will be performed where appropriate.
Measured: first collected sample within the first week after admission
Active TB host response Direct LS-TA in monocytes (Type II interferon response)
Direct LS-TA is a kind of RBB that can be readily quantified by qPCR or dPCR of a pair of genes, the RBB numerator gene and the RBB denominator gene. The biomarker is the ratio of the 2 genes. Single cell-type: Monocyte.
RBB numerator gene: WARS1, ATF3 or CALHM6. RBB denominator gene: PSAP, CTSS or CPVL. The various RBB will be compared in terms of their sensitivity/specificity of diagnostic performance in infection groups. AUC of ROC analysis will be performed where appropriate.
Measured: first collected sample within the first week after admission
Active TB host response Direct LS-TA in granulocytes (Type II interferon response)
Direct LS-TA is a kind of RBB that can be readily quantified by qPCR or dPCR of a pair of genes, the RBB numerator gene and the RBB denominator gene. The biomarker is the ratio of the 2 genes. Single cell-type: granulocyte. RBB numerator gene: ANKRD22, BATF2, CD274, FCGR1A or ETV7.
RBB denominator gene: SAT1 or SRGN. The various RBB will be compared in terms of their sensitivity/specificity of diagnostic performance in infection groups. AUC of ROC analysis will be performed where appropriate.
Measured: first collected sample within the first week after admission
Secondary outcomes (2)
DIRECT LS-TA results distribution and median of these DIRECT LS-TA RBB in infection groups
The statistical distribution of the biomarker and statistical comparison to the control range or comparison to control group median. The outcomes will be reported as p-values of the statistical tests.
Measured: first collected sample within the first week after admission
Method evaluation to compare the performance of quantitative PCR and digital PCR
Evaluate the assay performance and precision of both TA quantification methods: quantitative PCR and digital PCR.
Quantitative PCR results will be reported as delta-delta CT values. Digital PCR results will be reported as ratios of 2 counts. And then converted to multiple of mean/median in the control control (MoM) for comparison with delta-delta CT values.
Measured: first collected sample within the first week after admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2025
- Study startFeb 2025 (estimated)
- Primary completionSep 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Single Cell Sequencing TechnologyStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nelson Tang, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06846645
- Sponsor's protocol ID
- Direct LS-TA prospective study
- Status last verified
- Feb 2025
- First submitted
- 18 Feb 2025
- Last updated
- 3 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Descriptive statistics of results will be provided on a reasonable request.
Publications
Huang D, Liu AYN, Leung KS, Tang NLS. Direct Measurement of B Lymphocyte Gene Expression Biomarkers in Peripheral Blood Transcriptomics Enables Early Prediction of Vaccine Seroconversion. Genes (Basel). 2021 Jun 25;12(7):971. doi: 10.3390/genes12070971.
PubMed 34202032Huang B, Huang J, Chiang NH, Chen Z, Lui G, Ling L, Kwan MYW, Wong JSC, Mak PQ, Ling JWH, Lam ICS, Ng RWY, Wang X, Gao R, Hui DS, Ma SL, Chan PKS, Tang NLS. Interferon response and profiling of interferon response genes in peripheral blood of vaccine-naive COVID-19 patients. Front Immunol. 2024 Jan 10;14:1315602. doi: 10.3389/fimmu.2023.1315602. eCollection 2023.
PubMed 38268924
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peripheral Blood Single Cell-type Expression Profile of Interferon-stimulated and Other Biomarker Genes for Triage of Febrile Patients
- ClinicalTrials.gov ID
- NCT06846645
- Acronym / sponsor ID
- Direct LS-TA prospective study
- Conditions
- Single Cell Sequencing Technology, Gene Expression Profiling, Gene Expression, Infection, Viral Diseases, Bacterial Diseases
- Keywords
- host response, transcriptome, single cell-type gene expression, single cell RNA, triage, fever, febrile patient, Direct LS-TA
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- Feb 2025 (estimated)
- Primary completion
- Sep 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 26 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Febrile illness is a common condition and it is crucial to have an early triage of patients according to various aetiologies to enable appropriate treatment. Currently, most screening/diagnostic tests target the detection of pathogens, while only a few assays aim to understand the host response, and they are mostly based on a measurement of serum proteins (e.g. CRP or procalcitonin).
Recently, blood transcriptome has been explored to differentiate bacterial and viral infections. However, gene expression in blood represents a composite score of gene expression of all the component cell-types present in the sample. Here, we propose to develop a rapid test that can determine gene expressions of a specified single cell type in peripheral blood (e.g., monocytes or granulocytes) as a host response biomarker to differentiate three major categories of infections that are bacterial, viral, and tuberculosis The assay is called Direct Leukocyte Single cell-type transcript abundance (TA) assay (DIRECT LS-TA) as it can directly determine the gene expression of a specified single cell-type among various other leukocyte populations directly in a peripheral blood sample. Such results signify the nature of host response according to 3 or more axes (Type I or Type II interferon signaling response or pro-inflammatory cytokine signaling) And it can be used to indicate the type of underlying infection (viral, bacterial, or active tuberculosis).
Detailed description
DIRECT LS-TA is a ratio-based biomarker (RBB) for blood gene expression analysis which can be performed in commonly available equipments (e.g. qPCR or digital PCR machines). Using the ratio of TA of prior defined numerator gene and denominator gene, this RBB can quantify gene expression of the specified constitutional single cell-type (e.g. monocytes and granulocytes) inside a cell-mixture sample of Whole blood. DIRECT LS-TA was a method pioneered by the PI [Tang 2017, https://patents.google.com/patent/US9589099B2/]. And it has been developed for quantification of early B cell response after vaccination [DOI: 10.3390/genes12070971]. Recently, the method is used to develop host response biomarkers after infection to differentiate the type of pathogens (such as viral, bacterial or active tuberculosis). Numerator and denominator genes have been identified by using public gene expression datasets for monocytes and granulocytes. Diagnostic performance was good using these public data. Therefore, these RBBs will be applied in the prospective study to evaluate and compare their diagnostic (triage) performance of febrile patients into different pathogen etiologies.
Comparing to other methods to obtain single cell-type gene expression data, DIRECT LS-TA has many advantages The conventional (gold standard) approach is to quantify gene expression in a sample of purified single cell-type from peripheral blood but it is very labour intensive procedure. Recent single-cell RNA sequencing can also provide gene expression data for every individual cell in a sample, but it is slow and very costly. DIRECT LS-TA provides the unique technique to quantify single cell-type gene expression in blood samples without the need to isolate the targeted cell-type. It has been used to differentiate the type of host response in fever patients into 3 major axes (Type I or Type II interferon signaling response or pro-inflammatory cytokine signaling) which correspond to the nature of underlying infection aetiologies (viral infection, active tuberculosis and bacterial infection).
See preprint DOI: 10.1101/2025.01.27.634977. and patents in B cells : https://patents.google.com/patent/WO2022089426A1/ Monocytes: https://patents.google.com/patent/WO2023109365A1/ Granulocytes : https://patents.google.com/patent/GB202400180D0/
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Bacterial infection group | – | Other: No interventionA prospective sample of adult patients who later confirmed to have fever due to bacterial infection by positive culture results. |
| Viral infection group | – | Other: No interventionA prospective sample of adult patients who later confirmed to have fever due to viral infection by positive pathogen diagnostic results. |
| Active tuberculosis group | – | Other: No interventionA prospective sample of adult patients who later confirmed to have fever due to active tuberculosis by clinical diagnosis and/or positive pathogen results. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with fever due to infections which are later clinically diagnosed as viral infection, bacterial infection or active tuberculosis.
Key inclusion criteria (2 listed)
- Adult patients with fever of acute onset which is defined by a raised body temperature.
- Patient should understand Chinese word to give informed consent.
Key exclusion criteria (1 listed)
- Patients with a history of any immunodeficiency or immunocompromised condition. Patients received steriod or other immunotherapy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionPatients will receive clinical treatment with no special intervention in this observational study. There is no difference in term of treatment of patients. It only involves one additional blood sampling early after admission. | Other | Active tuberculosis group, Bacterial infection group, Viral infection group |
Primary outcome
Viral host response Direct LS-TA in monocytes (Type I interferon response)
Time frame: first collected sample within the first week after admission
Direct LS-TA is a kind of RBB that can be readily quantified by qPCR or dPCR of a pair of genes, the RBB numerator gene and the RBB denominator gene. The biomarker is the ratio of the 2 genes. Single cell-type: Monocyte. RBB numerator gene: IFI27 or IFI44L. RBB denominator gene: PSAP, CTSS or CPVL. The various RBB (e.g. IFI27/PSAP and IFI44L/PSAP ratios) will be compared in terms of their sensitivity/specificity of diagnostic performance in the samples from infection groups. AUC of ROC analysis will be performed where appropriate.
Viral host response Direct LS-TA in granulocytes (Type I interferon response)
Time frame: first collected sample within the first week after admission
Direct LS-TA is a kind of RBB that can be readily quantified by qPCR or dPCR of a pair of genes, the RBB numerator gene and the RBB denominator gene. The biomarker is the ratio of the 2 genes. Single cell-type: Granulocyte. RBB numerator gene: RSAD2 or IFIT1. RBB denominator gene: SAT1 or SRGN. The various RBB will be compared in terms of their sensitivity/specificity of diagnostic performance in the infection groups. AUC of ROC analysis will be performed where appropriate.
Bacterial infection host response Direct LS-TA in monocytes (pro-inflammatory response)
Time frame: first collected sample within the first week after admission
Direct LS-TA is a kind of RBB that can be readily quantified by qPCR or digital PCR (dPCR) of a pair of genes, the RBB numerator gene and the RBB denominator gene. The biomarker is the ratio of the 2 genes. Single cell-type: Monocyte. RBB numerator gene: VNN1 or NLRC4. RBB denominator gene: PSAP, CTSS or CPVL. The various RBBs will be compared in terms of their sensitivity/specificity of diagnostic performance in the infection groups. AUC of ROC analysis will be performed where appropriate.
Bacterial infection host response Direct LS-TA in granulocytes (pro-inflammatory response)
Time frame: first collected sample within the first week after admission
Direct LS-TA is a kind of RBB that can be readily quantified by qPCR or dPCR of a pair of genes, the RBB numerator gene and the RBB denominator gene. The biomarker is the ratio of the 2 genes. Single cell-type: Granulocyte. RBB numerator gene: ALPL, ANXA3 or ARG1. RBB denominator gene: SAT1 or SRGN. The various RBB will be compared in terms of their sensitivity/specificity of diagnostic performance in the infection groups. AUC of ROC analysis will be performed where appropriate.
Active TB host response Direct LS-TA in monocytes (Type II interferon response)
Time frame: first collected sample within the first week after admission
Direct LS-TA is a kind of RBB that can be readily quantified by qPCR or dPCR of a pair of genes, the RBB numerator gene and the RBB denominator gene. The biomarker is the ratio of the 2 genes. Single cell-type: Monocyte. RBB numerator gene: WARS1, ATF3 or CALHM6. RBB denominator gene: PSAP, CTSS or CPVL. The various RBB will be compared in terms of their sensitivity/specificity of diagnostic performance in infection groups. AUC of ROC analysis will be performed where appropriate.
Active TB host response Direct LS-TA in granulocytes (Type II interferon response)
Time frame: first collected sample within the first week after admission
Direct LS-TA is a kind of RBB that can be readily quantified by qPCR or dPCR of a pair of genes, the RBB numerator gene and the RBB denominator gene. The biomarker is the ratio of the 2 genes. Single cell-type: granulocyte. RBB numerator gene: ANKRD22, BATF2, CD274, FCGR1A or ETV7. RBB denominator gene: SAT1 or SRGN. The various RBB will be compared in terms of their sensitivity/specificity of diagnostic performance in infection groups. AUC of ROC analysis will be performed where appropriate.
2 secondary outcomes
DIRECT LS-TA results distribution and median of these DIRECT LS-TA RBB in infection groups
Time frame: first collected sample within the first week after admission
Method evaluation to compare the performance of quantitative PCR and digital PCR
Time frame: first collected sample within the first week after admission
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2025.
- Background: PubMed 34202032Huang D, Liu AYN, Leung KS, Tang NLS. Direct Measurement of B Lymphocyte Gene Expression Biomarkers in Peripheral Blood Transcriptomics Enables Early Prediction of Vaccine Seroconversion. Genes (Basel). 2021 Jun 25;12(7):971. doi: 10.3390/genes12070971.
- Background: PubMed 38268924Huang B, Huang J, Chiang NH, Chen Z, Lui G, Ling L, Kwan MYW, Wong JSC, Mak PQ, Ling JWH, Lam ICS, Ng RWY, Wang X, Gao R, Hui DS, Ma SL, Chan PKS, Tang NLS. Interferon response and profiling of interferon response genes in peripheral blood of vaccine-naive COVID-19 patients. Front Immunol. 2024 Jan 10;14:1315602. doi: 10.3389/fimmu.2023.1315602. eCollection 2023.
- Determination of gene expression levels of a cell typeLink provided by the sponsor.
- Method for measuring gene expression of single cell subpopulation, related kit, and applicationLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. Descriptive statistics of results will be provided on a reasonable request.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Single Cell Sequencing Technology and Gene Expression Profiling, run by Chinese University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tang (852 35053330, nelsontang@cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Viral host response Direct LS-TA in monocytes (Type I interferon response) (time frame: first collected sample within the first week after admission). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06846645, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2025.