An interventional study of Baseline MxA testing and Serial MxA testing in Respiratory Viral Infections, Influenza and SARS CoV 2 Infection, sponsored by Capital Medical University. Not yet recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-23.
Sponsored by Capital Medical University · Not applicable, Interventional, and Treatment
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.
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.
2,264 studies on the registry are indexed under Influenza, Human; 173 are open to participants now.
This study's planned enrollment of 618 is above the median of 240 across 1,894 interventional studies indexed under Influenza, Human.
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Exclusion Criteria:
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.
Other: Baseline MxA testing · Other: Serial MxA testing · Other: MxA result feedback and antiviral treatment recommendations · Other: Follow-up at Day 30
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.
Other: Baseline MxA testing · Other: Follow-up at Day 30 · Other: Usual care
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.
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 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.
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.
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.
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.
Time frame: 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.
Time frame: 30 days
Length of hospital stay
Defined as the total number of hospital days by Day 30.
Time frame: 30 days
Proportion of participants receiving antiviral treatment
Proportion of participants who receive antiviral treatment from randomization through day 30.
Time frame: 30 days
Plan to share: 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.
Supporting information: Study protocol, Informed consent form, Clinical study report
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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