Application of Myxovirus Resistance Protein A in Antiviral Treatment Guidance of Respiratory Viral Infections
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 86
- Locations
- 1
- Primary Endpoint
- 30-Day recurrence rate
Study Overview
Brief Summary
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.
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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
Intervention: MxA tests (Other)
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
Intervention: MxA feedback (Other)
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
Intervention: Follow-up at Day 30 (Other)
Control group
Telephone Visit at Day 30
Intervention: Follow-up at Day 30 (Other)
Outcomes
Primary Outcomes
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
- 30-day adverse outcomes(30 days)
- Total antiviral-days by day 30(30 days)
- Antiviral-days by day 30(30 days)
- Length of hospital stay(30 days)
- 30-day mortality(30 days)
- Incidence of mechanical ventilation(30 days)
- Incidence of complications(30 days)
- ICU admission rate(30 days)
- Readmission rate(30 days)
Investigators
Bin Cao
Professor
Capital Medical University