InfluenzaRAPID-ARIEDNCT06780566
Routine Application of Point-of-care PCR Test to Identify and Direct Therapy for Acute Respiratory Infection in the Emergency Department Trial
A study testing Point-of-care PCR testing for respiratory viruses and Laboratory PCR testing for respiratory viruses in people with Influenza and COVID-19, run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
The RAPID-ARIED Trial is a pragmatic, single-centre, parallel group, open-label, randomised controlled trial to be conducted in the Accident and Emergency Department of Queen Mary Hospital in Hong Kong. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Influenza, COVID-19, Acute Respiratory Infections (ARIs)
- What is being tested?
- Point-of-care PCR testing for respiratory viruses and Laboratory PCR testing for respiratory viruses
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,050 participants
- Where
- 1 siteHong Kong
- Study dates
- 30 Apr 2025to 31 Aug 2027
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients aged 18 years or above
- Intended for admission to hospital with acute respiratory illness (defined as a provisional diagnosis of pneumonia, bronchitis, influenza-like illness, acute exacerbation of chronic obstructive pulmonary disease, asthma or bronchiectasis.)
- Respiratory symptoms present ≤10 days before admission to hospital
- No prior treatment with antibiotics or antivirals in the previous 14 days
Who cannot join
- Refusal of nasal or pharyngeal swabbing
- Refusal of informed consent
- Previously included in the study and re-presentation within 28 days of hospital discharge
- A prior positive test by antigen test or other PCR test for COVID-19 or influenza before ED presentation
- Exposure to FluMist® or other similar live attenuated influenza vaccines within 1 month (because such exposures may lead to a false positive PCR test result with the nasal swab sample).
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
Accident and Emergency Department, Queen Mary Hospital
Hong Kong, None Selected
Rex Lam, MBBS, MPH, FHKCEM, 85239179413, lampkrex@hku.hk
Joanne Leung, 85239179715, cjojoy@hku.hk
About this study
Official title: Routine Application of Point-of-care PCR Test to Identify and Direct Therapy for Acute Respiratory Infection in the Emergency Department (RAPID-ARIED) Trial
The RAPID-ARIED Trial is a pragmatic, single-centre, parallel group, open-label, randomised controlled trial to be conducted in the Accident and Emergency Department of Queen Mary Hospital in Hong Kong. The investigators aim to 1) to evaluate the clinical impact of the routine application of point-of-care polymerase chain reaction (PCR) testing for targeted respiratory pathogens in the emergency department (ED) for adult patients with acute respiratory infections (ARIs) on the hospital length of stay (LOS), antiviral and antibiotic use during influenza seasons or future waves of COVID-19; and 2) to conduct a health economic analysis of such a strategy.
The investigators hypothesise that in adult patients hospitalised from the ED for ARIs during influenza seasons or COVID-19 waves, routine point-of-care PCR test for influenza A\&B, SARS-CoV-2 and respiratory syncytial virus in the ED reduces the hospital LOS significantly and cost effectively compared to usual care.
Read more
In total, 1,050 adult patients who are intended to be admitted to hospital with ARIs in the ED will be recruited during influenza seasons or future waves of COVID-19 over 36 months from 2025 to 2027.
Participants will be randomised (1:1 ratio) into the interventional group and control group. A nasal swab will be collected. In the intervention group, research staff will perform PCR test using the GeneXpert® Xpress PCR kit in the ED and communicate the test results to the patient and the clinical team. In the control group, all microbiology tests will be determined by the clinical team, with retrospective PCR testing of the nasal swab sample after 28 days.
The primary outcome is the median hospital LOS. Secondary outcomes include antivirals and antibiotics use and administration time, mortality, and quality-adjusted life year, assessed using the EQ-5D-5L questionnaire.
Intention-to-treat analysis (superiority framework) and cost-effectiveness analysis (from healthcare provider perspective) will be conducted.
Study results will provide evidence regarding the optimal PCR testing strategy in the future influenza seasons and COVID-19 waves.
- Conditions
- Influenza, COVID-19, Acute Respiratory Infections (ARIs)
- Being tested
- Point-of-care PCR testing for respiratory viruses, Laboratory PCR testing for respiratory viruses
- Keywords
- COVID-19, Acute respiratory infections, Point-of-care testing, Polymerase Chain Reaction, Randomized controlled trial, emergency department, Influenza
- Medical subject headings
- Influenza, Human, COVID-19, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Point-of-care PCR testing for respiratory virusesDiagnostic test
A nasal swab will be collected by trained research staff in full personal protective equipment (PPE) and placed into 3 mL of viral transport medium. The sample will be immediately processed and analysed in the ED using the Xpert® Xpress SARS-CoV-2/Flu/RSV test according to the manufacturer's instructions. The results of the test will be documented in the patient's paper or electronic case notes, and the clinical team will be directly informed of all results. The participant or legal guardian who signs the consent form will also be informed of the results when appropriate.
Laboratory PCR testing for respiratory virusesDiagnostic test
The ordering of test for respiratory pathogens will be decided by the treating clinical team. All tests will be performed using the standard methods of the hospital laboratory.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Point-of-care PCR testing for respiratory viruses in the ED Receives: Diagnostic Test: Point-of-care PCR testing for respiratory viruses |
| Control Group | Other | Laboratory PCR testing for respiratory viruses after admission to the hospital floor Receives: Diagnostic Test: Laboratory PCR testing for respiratory viruses |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospital length of stay
Hospital length of stay in days
Measured: From enrollment to day 28
Secondary outcomes (14)
Neuraminidase inhibitors use
Proportion of neuraminidase inhibitor use in patients with and without influenza
Measured: From enrollment to day 28
Nirmatrelvir-ritonavir or molnupiravir use
Proportion of nirmatrelvir-ritonavir or molnupiravir use in patients with and without COVID-19
Measured: From enrollment to day 28
Median time to antiviral commencement from ED registration
Median time to antiviral commencement from ED registration in hours
Measured: From enrollment to day 28
Antibiotic use
Proportion of antibiotic use in patients
Measured: From enrollment to day 28
Median time to antibiotic commencement from ED registration
Median time to antibiotic commencement from ED registration in hours
Measured: From enrollment to day 28
ICU admission
Proportion of patients requiring admission to an intensive care unit (ICU) or a high dependency unit (HDU), censored at 28 days post-enrolment
Measured: From enrollment to day 28
ICU length of stay
Median duration of stay in ICU and/or HDU in days
Measured: From enrollment to day 28
Proportion of patients requiring non-invasive ventilation during their hospital stay
Proportion of patients requiring non-invasive ventilation during their hospital stay
Measured: From enrollment to day 28
Proportion of patients requiring mechanical ventilation during their hospital stay
Proportion of patients requiring mechanical ventilation during their hospital stay
Measured: From enrollment to day 28
Ventilator-free days
Ventilator-free days
Measured: From enrollment to day 28
28-day All-cause mortality
All-cause mortality
Measured: From enrollment to day 28
In-hospital mortality
In-hospital mortality
Measured: From enrollment to day 28
Proportion of patients readmitted to hospital within 28 days of hospital discharge
Proportion of patients readmitted to hospital within 28 days of hospital discharge
Measured: From hospital discharge to day 28 after hospital discharge
Health-related quality of life
Health-related quality of life measured with five-level EuroQol five-dimensional questionnaire (EQ-5D-5L)
Measured: Day 1 ,7, 14, 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2025
- Study start30 Apr 2025 (estimated)
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfluenzaStudies of the same condition, open and under way.
- More trials run by The 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- After obtaining informed consent, each recruited participant will be given a unique participant identification number. Research team members will then use this identification number to randomise participants in a 1:1 ratio to either the intervention group or the control group. Permuted blocks of varying size (4, 6, and 8) will be generated using internet-based randomisation software
- Masking
- None (open label)
- Enrolment
- 1,050 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lam Pui Kin, The University of Hong Kong
- Investigators
- Pui Kin Rex Lam, MBBS, MPH, FHKCEM, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06780566
- Sponsor's protocol ID
- RAPID-ARIED1
- Acronym
- RAPID-ARIED
- Status last verified
- Mar 2025
- First submitted
- 13 Jan 2025
- Last updated
- 28 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: IPD requires additional IRB approval because of local patient privacy ordinance.
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Routine Application of Point-of-care PCR Test to Identify and Direct Therapy for Acute Respiratory Infection in the Emergency Department (RAPID-ARIED) Trial
- ClinicalTrials.gov ID
- NCT06780566
- Acronym / sponsor ID
- RAPID-ARIED / RAPID-ARIED1
- Conditions
- Influenza, COVID-19, Acute Respiratory Infections (ARIs)
- Keywords
- COVID-19, Acute respiratory infections, Point-of-care testing, Polymerase Chain Reaction, Randomized controlled trial, emergency department, Influenza
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,050 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 30 Apr 2025 (estimated)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 17 Jan 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.
The RAPID-ARIED Trial is a pragmatic, single-centre, parallel group, open-label, randomised controlled trial to be conducted in the Accident and Emergency Department of Queen Mary Hospital in Hong Kong. The investigators aim to 1) to evaluate the clinical impact of the routine application of point-of-care polymerase chain reaction (PCR) testing for targeted respiratory pathogens in the emergency department (ED) for adult patients with acute respiratory infections (ARIs) on the hospital length of stay (LOS), antiviral and antibiotic use during influenza seasons or future waves of COVID-19; and 2) to conduct a health economic analysis of such a strategy.
The investigators hypothesise that in adult patients hospitalised from the ED for ARIs during influenza seasons or COVID-19 waves, routine point-of-care PCR test for influenza A\&B, SARS-CoV-2 and respiratory syncytial virus in the ED reduces the hospital LOS significantly and cost effectively compared to usual care.
In total, 1,050 adult patients who are intended to be admitted to hospital with ARIs in the ED will be recruited during influenza seasons or future waves of COVID-19 over 36 months from 2025 to 2027.
Participants will be randomised (1:1 ratio) into the interventional group and control group. A nasal swab will be collected. In the intervention group, research staff will perform PCR test using the GeneXpert® Xpress PCR kit in the ED and communicate the test results to the patient and the clinical team. In the control group, all microbiology tests will be determined by the clinical team, with retrospective PCR testing of the nasal swab sample after 28 days.
The primary outcome is the median hospital LOS. Secondary outcomes include antivirals and antibiotics use and administration time, mortality, and quality-adjusted life year, assessed using the EQ-5D-5L questionnaire.
Intention-to-treat analysis (superiority framework) and cost-effectiveness analysis (from healthcare provider perspective) will be conducted.
Study results will provide evidence regarding the optimal PCR testing strategy in the future influenza seasons and COVID-19 waves.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- After obtaining informed consent, each recruited participant will be given a unique participant identification number. Research team members will then use this identification number to randomise participants in a 1:1 ratio to either the intervention group or the control group. Permuted blocks of varying size (4, 6, and 8) will be generated using internet-based randomisation software
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Diagnostic Test: Point-of-care PCR testing for respiratory virusesPoint-of-care PCR testing for respiratory viruses in the ED |
| Control Group | Other | Diagnostic Test: Laboratory PCR testing for respiratory virusesLaboratory PCR testing for respiratory viruses after admission to the hospital floor |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult patients aged 18 years or above
- Intended for admission to hospital with acute respiratory illness (defined as a provisional diagnosis of pneumonia, bronchitis, influenza-like illness, acute exacerbation of chronic obstructive pulmonary disease, asthma or bronchiectasis.)
- Respiratory symptoms present ≤10 days before admission to hospital
- No prior treatment with antibiotics or antivirals in the previous 14 days
Key exclusion criteria (5 listed)
- Refusal of nasal or pharyngeal swabbing
- Refusal of informed consent
- Previously included in the study and re-presentation within 28 days of hospital discharge
- A prior positive test by antigen test or other PCR test for COVID-19 or influenza before ED presentation
- Exposure to FluMist® or other similar live attenuated influenza vaccines within 1 month (because such exposures may lead to a false positive PCR test result with the nasal swab sample).
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 |
|---|---|---|
| Point-of-care PCR testing for respiratory virusesA nasal swab will be collected by trained research staff in full personal protective equipment (PPE) and placed into 3 mL of viral transport medium. The sample will be immediately processed and analysed in the ED using the Xpert® Xpress SARS-CoV-2/Flu/RSV test according to the manufacturer's instructions. The results of the test will be documented in the patient's paper or electronic case notes, and the clinical team will be directly informed of all results. The participant or legal guardian who signs the consent form will also be informed of the results when appropriate. | Diagnostic test | Intervention Group |
| Laboratory PCR testing for respiratory virusesThe ordering of test for respiratory pathogens will be decided by the treating clinical team. All tests will be performed using the standard methods of the hospital laboratory. | Diagnostic test | Control Group |
Primary outcome
Hospital length of stay
Time frame: From enrollment to day 28
Hospital length of stay in days
14 secondary outcomes
Neuraminidase inhibitors use
Time frame: From enrollment to day 28
Nirmatrelvir-ritonavir or molnupiravir use
Time frame: From enrollment to day 28
Median time to antiviral commencement from ED registration
Time frame: From enrollment to day 28
Antibiotic use
Time frame: From enrollment to day 28
Median time to antibiotic commencement from ED registration
Time frame: From enrollment to day 28
ICU admission
Time frame: From enrollment to day 28
ICU length of stay
Time frame: From enrollment to day 28
Proportion of patients requiring non-invasive ventilation during their hospital stay
Time frame: From enrollment to day 28
Proportion of patients requiring mechanical ventilation during their hospital stay
Time frame: From enrollment to day 28
Ventilator-free days
Time frame: From enrollment to day 28
28-day All-cause mortality
Time frame: From enrollment to day 28
In-hospital mortality
Time frame: From enrollment to day 28
Proportion of patients readmitted to hospital within 28 days of hospital discharge
Time frame: From hospital discharge to day 28 after hospital discharge
Health-related quality of life
Time frame: Day 1 ,7, 14, 28
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 28 Mar 2025.
- Individual participant dataSharing planned: Undecided. IPD requires additional IRB approval because of local patient privacy ordinance.
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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.
Pui Kin Rex Lam, MBBS, MPH, FHKCEM principal investigator
The University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Point-of-care PCR testing for respiratory viruses and Laboratory PCR testing for respiratory viruses in people with Influenza and COVID-19, run by The 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 4 inclusion and 5 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 28 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 Rex Pui Kin Lam, MBBS, MPH, FHKCEM (+852 39179413, lampkrex@hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hospital length of stay (time frame: From enrollment to day 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Mar 2025.