MxA-Guided Antiviral Treatment in Respiratory Viral Infections

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.

Study Overview

• Status: Completed
• Conditions: Influenza; SARS CoV-2; Respiratory Viral Infections
• Intervention / Treatment: Other: MxA tests; Other: MxA feedback; Other: Follow-up at Day 30

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 Type: Interventional
• Enrollment (Actual): 86
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100029
      • China-Japan Friendship Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• ≥ 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

Exclusion Criteria:

• 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
• Active tuberculosis
• With contraindications for antiviral treatment
• Unable to obtain eligible samples
• Co-infected with influenza and COVID-19

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MxA group; Perform MxA test; MxA results reported to attending clinicians; Provide MxA-based guidelines on antiviral treatment to attending clinicians; Telephone Visit at Day 30	Other: MxA tests; 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.; Other: MxA feedback; MxA results will be reported to the attending physician within 4 hours, along with MxA-based antiviral treatment guidelines.; Other: Follow-up at Day 30; 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.
Active Comparator: Control group; Telephone Visit at Day 30	Other: Follow-up at Day 30; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	30 days
Length of hospital stay	Defined as the total number of hospital days by Day 30.	30 days
30-day mortality	Defined as the proportion of patients who died by Day 30.	30 days
Incidence of mechanical ventilation	Defined as the proportion of patients receiving mechanical ventilation by day 30.	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.	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.	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.	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
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.	30 days

Collaborators and Investigators

• Sponsor: Capital Medical University
• Collaborators: China-Japan Friendship Hospital; Chinese Academy of Medical Sciences
• Investigators: Study Director: Bin Cao, China-Japan Friendship Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 12, 2024
• Primary Completion (Actual): January 28, 2026
• Study Completion (Actual): February 12, 2026

Study Registration Dates

• First Submitted: October 30, 2024
• First Submitted That Met QC Criteria: October 30, 2024
• First Posted (Actual): October 31, 2024

Study Record Updates

• Last Update Posted (Actual): March 4, 2026
• Last Update Submitted That Met QC Criteria: March 2, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Influenza, Human
• Other Study ID Numbers: 2023-I2M-C&T-B-119

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: IPD used in the results publication will be shared.
• IPD Sharing Supporting Information Type: ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No