Respiratory Viral InfectionsNCT07892872
Effect of MxA Guidance on Antiviral Treatment in Respiratory Viral Infections
A study testing Baseline MxA testing, Serial MxA testing and MxA result feedback and antiviral treatment recommendations in people with Respiratory Viral Infections and Influenza, run by Capital Medical University at 1 site in China.
Trial summary
The goal of this clinical trial is to evaluate the effects of myxovirus resistance protein A (MxA)-guided antiviral treatment on treatment duration and adverse outcomes in adults hospitalized with influenza or COVID-19, compared with usual care. 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 Infection
- What is being tested?
- Baseline MxA testing, Serial MxA testing and MxA result feedback and antiviral treatment recommendations
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 618 participants
- Where
- 1 siteChina
- Study dates
- 30 Nov 2026to 29 Feb 2028
- Phase
- Interventional
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
- Age ≥ 18 years old
- Hospitalized with suspected lower respiratory tract infection (influenza or SARS-CoV-2) , with influenza virus or SARS-CoV-2 infection confirmed by antigen testing or PCR, and a symptom duration of ≤14 days.
- Currently receiving or planned to receive antiviral treatment, with no decision yet made regarding discontinuation of antiviral therapy
Who cannot join
- Tracheal intubation/tracheotomy with mechanical ventilation
- Use vasoactive drugs
- Immunesuppression
- Receipt of interferon therapy within the past 30 days.
- Conditions associated with a systemic inflammatory response within the past 30 days, such as stroke, myocardial infarction, or surgery.
- Receipt of vaccination within the past 30 days.
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- Active tuberculosis
- Coinfection with other respiratory viruses or atypical pathogens.
- Contraindications to antiviral therapy.
- Inability to obtain adequate samples for study-related testing.
- Coinfection with influenza virus and SARS-CoV-2.
- Expected hospital discharge or death within 48 hours.
- Combined rheumatic and autoimmune diseases, such as inflammatory diseases, systemic lupus erythematosus, systemic sclerosis, Sjögren's syndrome, etc
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
China-Japan Friendship hospital
Beijing
Yeming Wang, M.D., +86 84206264, wwyymm_love@163.com
About this study
Official title: Effect of Myxovirus Resistance Protein A Guidance on Antiviral Treatment in Respiratory Viral Infections
The goal of this clinical trial is to evaluate the effects of myxovirus resistance protein A (MxA)-guided antiviral treatment on treatment duration and adverse outcomes in adults hospitalized with influenza or COVID-19, compared with usual care.
Participants will be randomly assigned in a 1:1 ratio to the MxA group or the usual care group. In the MxA group, treating physicians will receive blood MxA test results together with treatment recommendations based on those results. In the usual care group, treating physicians will make antiviral treatment decisions without access to MxA results.
Read the detailed description
The optimal duration of antiviral treatment in hospitalized patients with influenza or COVID-19 remains uncertain. Decisions about treatment discontinuation commonly rely on clinical improvement and respiratory viral testing. However, clinical assessments may vary between physicians, and respiratory viral test results alone may not fully characterize the host response to infection. A blood-based host-response marker could provide additional information to support individualized decisions about when to discontinue antiviral treatment.
Myxovirus resistance protein A (MxA) is an interferon-induced protein involved in the host antiviral response. Preliminary studies conducted by the research team support its potential as a marker of respiratory viral infection and disease activity. This confirmatory trial will evaluate whether incorporating serial blood MxA measurements into clinical decision-making can reduce antiviral treatment duration while maintaining acceptable clinical safety.
This is a prospective, multicenter, randomized, open-label, controlled trial with blinded endpoint assessment. Hospitalized adults with lower respiratory tract infection caused by influenza virus or SARS-CoV-2 will be allocated in a 1:1 ratio to MxA-guided care or usual care. Block randomization will be stratified by study center and virus type. Primary endpoints will be assessed by independent personnel blinded to treatment allocation.
In the MxA group, a peripheral blood sample will be obtained within 12 hours after randomization. Repeat MxA measurements will be performed on study days 4, 7, and 10 if the participant remains hospitalized and continues to receive antiviral treatment. Additional measurements may be performed at the treating physician's discretion. Results will be communicated to the treating physician within 4 hours, together with protocol-based treatment recommendations. Each recommendation should be interpreted in the context of the participant's clinical condition and all available clinical information. Treating physicians will retain responsibility for all treatment decisions and may depart from the recommendations when clinically appropriate.
Participants assigned to usual care will receive guideline-based management, with antiviral treatment decisions made by their treating physicians. A baseline blood sample will be collected for MxA measurement, but the result will not be disclosed to the treating physician or used to guide clinical care.
- Being tested
- Baseline MxA testing, Serial MxA testing, MxA result feedback and antiviral treatment recommendations, Follow-up at Day 30, Usual care
- Medical subject headings
- Influenza, Human, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Baseline MxA testingOther
A whole blood sample will be obtained within 12 hours after randomization for MxA measurement. Results will be disclosed to treating physicians only for participants assigned to the MxA-guided group.
Serial MxA testingOther
Repeat MxA measurements will be performed on study days 4, 7, and 10 if the participant remains hospitalized and continues to receive antiviral treatment. Additional measurements may be performed at the treating physician's discretion.
MxA result feedback and antiviral treatment recommendationsOther
MxA results will be communicated to treating physicians within 4 hours, together with protocol-based antiviral treatment recommendations. Results and recommendations should be interpreted alongside the participant's clinical condition and all available clinical information. Treating physicians will retain responsibility for all treatment decisions.
Follow-up at Day 30Other
Participants discharged before day 30 will receive a telephone follow-up on day 30, with an allowable window of 7 additional days, to collect information on antiviral medication use, symptoms and symptom recurrence, hospital readmissions, and additional medical visits.
Usual careOther
Participants will receive guideline-based clinical management. Treating physicians will determine whether to initiate, continue, or discontinue antiviral treatment based on clinical assessment and routinely available test results, without access to study MxA results.
| Study group | Role | What they receive |
|---|---|---|
| MxA group | Experimental | Participants will undergo serial MxA testing. Results and MxA-based antiviral treatment recommendations will be provided to treating physicians. Participants discharged before day 30 will receive a telephone follow-up on day 30. Receives: Other: Baseline MxA testing; Other: Serial MxA testing; Other: MxA result feedback and antiviral treatment recommendations; Other: Follow-up at Day 30 |
| Uscal care group | Active comparator | Participants will undergo baseline MxA testing, but the results will not be disclosed to treating physicians. Antiviral treatment decisions will follow usual care. Participants discharged before day 30 will receive a telephone follow-up on day 30. Receives: Other: Baseline MxA testing; Other: Follow-up at Day 30; Other: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Antiviral-days by day 30
Defined as the total number of days of antiviral treatment from randomization to the discontinuation of antiviral treatment by Day 30.
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
Secondary outcomes (1)
Length of hospital stay
Defined as the total number of hospital days 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 posted23 Oct 2026
- Study start30 Nov 2026 (estimated)
- Primary completion10 Feb 2028 (estimated)
- Study completion29 Feb 2028 (estimated)
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.
- 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
- 618 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Capital Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- China-Japan Friendship Hospital
- Responsible party
- Principal investigator, Bin Cao, Capital Medical University
- Investigators
- Bin Cao, M.D., Study director, China-Japan Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07892872
- Sponsor's protocol ID
- BRWEP2024W114060108
- Status last verified
- Oct 2026
- First submitted
- 18 Oct 2026
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data underlying the results reported in the study publication may be shared upon reasonable request after publication. Researchers requesting access must contact the principal investigator and submit a research proposal describing the purpose of the request, the intended use of the data, and their relevant qualifications. Requests will be reviewed by the principal investigator. Data access will be granted only after approval of the request and execution of a data use agreement between the requesting party and the institution responsible for the data.