MxA-Guided Antiviral Treatment in Respiratory Viral Infections

Capital Medical University

Status: Enrolling

Conditions: Influenza; Respiratory Viral Infections; SARS CoV-2

Treatments: Other: MxA tests; Other: Follow-up at Day 30; Other: MxA feedback

Study type: Interventional

Funder types: Other

Identifiers

NCT06668025

2023-I2M-C&T-B-119

Details and patient eligibility

About

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.

Full 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

Enrollment: 84 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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84 participants in 2 patient groups

MxA group

Experimental group

Description:

Perform MxA test; MxA results reported to attending clinicians; Provide MxA-based guidelines on antiviral treatment to attending clinicians; Telephone Visit at Day 30

Treatment:

Other: Follow-up at Day 30

Other: MxA feedback

Other: MxA tests

Control group

Active Comparator group

Description:

Telephone Visit at Day 30

Treatment:

Other: Follow-up at Day 30