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Completed

NCT Number: NCT06668025

MxA-Guided Antiviral Treatment in 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

China-Japan Friendship hospital

Beijing, Beijing Municipality, 100029, China

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MxA tests

Other

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 feedback

Other

MxA results will be reported to the attending physician within 4 hours, along with MxA-based antiviral treatment guidelines.

Follow-up at Day 30

Other

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Antiviral-days by day 30

    Time frame: 30 days

    Defined as the total number of days of antiviral treatment from randomization to the discontinuation of antiviral therapy by Day 30.

  2. Length of hospital stay

    Time frame: 30 days

    Defined as the total number of hospital days by Day 30.

  3. 30-day mortality

    Time frame: 30 days

    Defined as the proportion of patients who died by Day 30.

  4. Incidence of mechanical ventilation

    Time frame: 30 days

    Defined as the proportion of patients receiving mechanical ventilation by day 30.

  5. Incidence of complications

    Time frame: 30 days

    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.

  6. ICU admission rate

    Time frame: 30 days

    Defined as the incidence of transfer to the ICU within 30 days of enrollment for patients initially admitted to a general ward.

  7. Readmission rate

    Time frame: 30 days

    Defined as the incidence of readmission or additional medical visits within 30 days of enrollment for patients who have been discharged.

  8. 30-day adverse outcomes

    Time frame: 30 days

    Defined as the incidence of recurrence, death, mechanical ventilation, complications, ICU admission, or readmission or additional medical visits within 30 days of enrollment.

  9. Total antiviral-days by day 30

    Time frame: 30 days

    Defined as the total number of days of antiviral treatment from admission to the discontinuation of antiviral therapy by Day 30.

Sponsors and collaborators

Lead sponsor

Capital Medical University

Other

Collaborators

  • China-Japan Friendship Hospital
  • Chinese Academy of Medical Sciences

Registry information

Official study title

Application of Myxovirus Resistance Protein A in Antiviral Treatment Guidance of Respiratory Viral Infections

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Oct 31, 2024
Registry last updated
Mar 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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