Effect of MxA Guidance on Antiviral Treatment in Respiratory Viral Infections
Effect of Myxovirus Resistance Protein A Guidance on Antiviral Treatment in Respiratory Viral Infections
1 other identifier
interventional
618
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2026
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 18, 2026
CompletedFirst Posted
Study publicly available on registry
October 23, 2026
CompletedStudy Start
First participant enrolled
November 30, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
February 10, 2028
Study Completion
Last participant's last visit for all outcomes
February 29, 2028
October 23, 2026
October 1, 2026
1.2 years
October 18, 2026
October 18, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
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.
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.
30 days
Secondary Outcomes (1)
Length of hospital stay
30 days
Other Outcomes (1)
Proportion of participants receiving antiviral treatment
30 days
Study Arms (2)
MxA group
EXPERIMENTALParticipants 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.
Uscal care group
ACTIVE COMPARATORParticipants 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Capital Medical Universitylead
- China-Japan Friendship Hospitalcollaborator
Study Sites (1)
China-Japan Friendship hospital
Beijing, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bin Cao, M.D.
China-Japan Friendship Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
October 18, 2026
First Posted
October 23, 2026
Study Start (Estimated)
November 30, 2026
Primary Completion (Estimated)
February 10, 2028
Study Completion (Estimated)
February 29, 2028
Last Updated
October 23, 2026
Record last verified: 2026-10
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, ICF, CSR
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.