Respiratory Viral InfectionsNCT06668025
MxA-Guided Antiviral Treatment in Respiratory Viral Infections
A study testing MxA tests, MxA feedback and Follow-up at Day 30 in people with Respiratory Viral Infections and Influenza, run by Capital Medical University at 1 site in China.
Trial summary
This pilot randomized controlled trial (RCT) will investigate the clinical impact of Myxovirus Resistance Protein A (MxA)-guided antiviral treatment versus standard treatment in patients with respiratory viral infections. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory Viral Infections, Influenza, SARS CoV-2
- What is being tested?
- MxA tests, MxA feedback and Follow-up at Day 30
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteChina
- Study dates
- 12 Dec 2024to 12 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- ≥ 18 years old
- With a primary diagnosis of influenza or COVID-19 infection, diagnosed by a rapid antigen test or RT-PCR
- Duration of infection ≤14 days for non-severe patients and < 28 days for patients with severe infections
- Currently receiving or planned to receive antiviral treatment, with the attending physician yet to decide on the discontinuation of the antiviral treatment
Who cannot join
- Current endotracheal intubation and mechanical ventilation
- Current vasopressor use
- Known immunosuppression
- Received interferon therapy within 30 days before screening
- Systemic inflammatory responses within 30 days prior to screening, such as cerebral infarction, myocardial infarction, or surgery
- Received vaccine in the past 30 days
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- Active tuberculosis
- With contraindications for antiviral treatment
- Unable to obtain eligible samples
- Co-infected with influenza and COVID-19
Trial locations and contacts
1 site in 1 country.
China1 site
China-Japan Friendship hospital
Beijing, Beijing Municipality, 100029
About this study
Official title: Application of Myxovirus Resistance Protein A in Antiviral Treatment Guidance of Respiratory Viral Infections
This pilot randomized controlled trial (RCT) will investigate the clinical impact of Myxovirus Resistance Protein A (MxA)-guided antiviral treatment versus standard treatment in patients with respiratory viral infections.
Read the detailed description
Effective antiviral treatment would shorten the time to symptom resolution, accelerate the cessation of viral shedding, and improve the prognosis of respiratory viral infections. However, the optimal timing for antiviral treatment remains undetermined, and the current lack of objective biomarkers for respiratory viral infections often leads to either prolonged or insufficient antiviral treatment. Thus, there is a need for strategies that incorporate novel diagnostics to guide antiviral treatment and provide more individualized therapy.
Myxovirus resistance protein A (MxA), a novel marker of viral infection, may hold potential in guiding antiviral therapy. In this pilot randomized controlled clinical study, we aim to evaluate whether MxA-guided antiviral treatment, as compared to standard care, can reduce the recurrence rate of respiratory viral infections and improve clinical outcomes
- Conditions
- Respiratory Viral Infections, Influenza, SARS CoV-2
- Being tested
- MxA tests, MxA feedback, Follow-up at Day 30
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MxA testsOther
Whole blood samples will be collected on Days 1, 4, 7, and 10 for MxA testing. MxA measurements on Days 4, 7, and 10 will be performed only for patients still hospitalized on antiviral thearpy or at the attending physician's discretion.
MxA feedbackOther
MxA results will be reported to the attending physician within 4 hours, along with MxA-based antiviral treatment guidelines.
Follow-up at Day 30Other
A telephone visit will be conducted on or around Day 30 for study participants who are discharged, to collect information on antiviral usage, recurrence infection, readmissions, and additional medical visits.
| Study group | Role | What they receive |
|---|---|---|
| MxA group | Experimental | Perform MxA test; MxA results reported to attending clinicians; Provide MxA-based guidelines on antiviral treatment to attending clinicians; Telephone Visit at Day 30 Receives: Other: MxA tests; Other: MxA feedback; Other: Follow-up at Day 30 |
| Control group | Active comparator | Telephone Visit at Day 30 Receives: Other: Follow-up at Day 30 |
What is being measured
The primary outcome is the main question the study is designed to answer.
30-Day recurrence rate
Recurrence is defined as the worsening of symptoms and a positive viral PCR test from respiratory samples in patients who discontinued antiviral treatment within 30 days of enrollment.
Measured: 30 days
Secondary outcomes (9)
Antiviral-days by day 30
Defined as the total number of days of antiviral treatment from randomization to the discontinuation of antiviral therapy by Day 30.
Measured: 30 days
Length of hospital stay
Defined as the total number of hospital days by Day 30.
Measured: 30 days
30-day mortality
Defined as the proportion of patients who died by Day 30.
Measured: 30 days
Incidence of mechanical ventilation
Defined as the proportion of patients receiving mechanical ventilation by day 30.
Measured: 30 days
Incidence of complications
Defined as the incidence of complications such as bronchitis and viral pneumonia occurring within 30 days of enrollment in patients with an initial diagnosis of upper respiratory viral infection.
Measured: 30 days
ICU admission rate
Defined as the incidence of transfer to the ICU within 30 days of enrollment for patients initially admitted to a general ward.
Measured: 30 days
Readmission rate
Defined as the incidence of readmission or additional medical visits within 30 days of enrollment for patients who have been discharged.
Measured: 30 days
30-day adverse outcomes
Defined as the incidence of recurrence, death, mechanical ventilation, complications, ICU admission, or readmission or additional medical visits within 30 days of enrollment.
Measured: 30 days
Total antiviral-days by day 30
Defined as the total number of days of antiviral treatment from admission to the discontinuation of antiviral therapy by Day 30.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2024
- Study start12 Dec 2024
- Primary completion28 Jan 2026
- Study completion12 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Viral InfectionsStudies of the same condition, open and under way.
- More trials run by Capital Medical UniversityThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Capital Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- China-Japan Friendship Hospital, Chinese Academy of Medical Sciences
- Responsible party
- Principal investigator, Bin Cao, Capital Medical University
- Investigators
- Bin Cao, Study director, China-Japan Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06668025
- Sponsor's protocol ID
- 2023-I2M-C&T-B-119
- Status last verified
- Mar 2026
- First submitted
- 30 Oct 2024
- Last updated
- 4 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD used in the results publication will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Myxovirus Resistance Protein A in Antiviral Treatment Guidance of Respiratory Viral Infections
- ClinicalTrials.gov ID
- NCT06668025
- Acronym / sponsor ID
- 2023-I2M-C&T-B-119
- Conditions
- Respiratory Viral Infections, Influenza, SARS CoV-2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Capital Medical UniversityUniversity, hospital or other
- Collaborators
- China-Japan Friendship Hospital, Chinese Academy of Medical Sciences
- Study start
- 12 Dec 2024 (actual)
- Primary completion
- 28 Jan 2026 (actual)
- Study completion
- 12 Feb 2026 (actual)
- First posted
- 31 Oct 2024 (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.
This pilot randomized controlled trial (RCT) will investigate the clinical impact of Myxovirus Resistance Protein A (MxA)-guided antiviral treatment versus standard treatment in patients with respiratory viral infections.
Detailed description
Effective antiviral treatment would shorten the time to symptom resolution, accelerate the cessation of viral shedding, and improve the prognosis of respiratory viral infections. However, the optimal timing for antiviral treatment remains undetermined, and the current lack of objective biomarkers for respiratory viral infections often leads to either prolonged or insufficient antiviral treatment. Thus, there is a need for strategies that incorporate novel diagnostics to guide antiviral treatment and provide more individualized therapy.
Myxovirus resistance protein A (MxA), a novel marker of viral infection, may hold potential in guiding antiviral therapy. In this pilot randomized controlled clinical study, we aim to evaluate whether MxA-guided antiviral treatment, as compared to standard care, can reduce the recurrence rate of respiratory viral infections and improve clinical outcomes
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MxA group | Experimental | Other: MxA tests, Other: MxA feedback, Other: Follow-up at Day 30Perform MxA test; MxA results reported to attending clinicians; Provide MxA-based guidelines on antiviral treatment to attending clinicians; Telephone Visit at Day 30 |
| Control group | Active comparator | Other: Follow-up at Day 30Telephone Visit at Day 30 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ≥ 18 years old
- With a primary diagnosis of influenza or COVID-19 infection, diagnosed by a rapid antigen test or RT-PCR
- Duration of infection ≤14 days for non-severe patients and < 28 days for patients with severe infections
- Currently receiving or planned to receive antiviral treatment, with the attending physician yet to decide on the discontinuation of the antiviral treatment
Key exclusion criteria (10 listed)
- Current endotracheal intubation and mechanical ventilation
- Current vasopressor use
- Known immunosuppression
- Received interferon therapy within 30 days before screening
- Systemic inflammatory responses within 30 days prior to screening, such as cerebral infarction, myocardial infarction, or surgery
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 |
|---|---|---|
| MxA testsWhole blood samples will be collected on Days 1, 4, 7, and 10 for MxA testing. MxA measurements on Days 4, 7, and 10 will be performed only for patients still hospitalized on antiviral thearpy or at the attending physician's discretion. | Other | MxA group |
| MxA feedbackMxA results will be reported to the attending physician within 4 hours, along with MxA-based antiviral treatment guidelines. | Other | MxA group |
| Follow-up at Day 30A telephone visit will be conducted on or around Day 30 for study participants who are discharged, to collect information on antiviral usage, recurrence infection, readmissions, and additional medical visits. | Other | Control group, MxA group |
Primary outcome
30-Day recurrence rate
Time frame: 30 days
Recurrence is defined as the worsening of symptoms and a positive viral PCR test from respiratory samples in patients who discontinued antiviral treatment within 30 days of enrollment.
9 secondary outcomes
Antiviral-days by day 30
Time frame: 30 days
Length of hospital stay
Time frame: 30 days
30-day mortality
Time frame: 30 days
Incidence of mechanical ventilation
Time frame: 30 days
Incidence of complications
Time frame: 30 days
ICU admission rate
Time frame: 30 days
Readmission rate
Time frame: 30 days
30-day adverse outcomes
Time frame: 30 days
Total antiviral-days by day 30
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2026.
- Individual participant dataSharing planned: Yes. IPD used in the results publication will be shared.
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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. This study is not recruiting at the moment.
Bin Cao study director
China-Japan Friendship Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MxA tests, MxA feedback and Follow-up at Day 30 in people with Respiratory Viral Infections and Influenza, run by Capital Medical University at 1 site in China.
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 10 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: finished, as of the sponsor's last update on 4 Mar 2026. 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 China. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
30-Day recurrence rate (time frame: 30 days). 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 4 Mar 2026.