Clinical trial NCT06668025: MxA-Guided Antiviral Treatment in Respiratory Viral Infections
Official title: Application of Myxovirus Resistance Protein a in Antiviral Treatment Guidance of Respiratory Viral Infections
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Respiratory Viral Infections
Influenza
SARS CoV-2
Lead sponsor: Capital Medical University
Sponsor class: OTHER
Collaborators: name: China-Japan Friendship Hospital
name: Chinese Academy of Medical Sciences
First posted: 2024-10-31
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: 30-Day recurrence rate
timeFrame: 30 days
Secondary outcomes:
measure: Antiviral-days by day 30
timeFrame: 30 days
measure: Length of hospital stay
timeFrame: 30 days
measure: 30-day mortality
timeFrame: 30 days
measure: Incidence of mechanical ventilation
timeFrame: 30 days
measure: Incidence of complications
timeFrame: 30 days
measure: ICU admission rate
timeFrame: 30 days
measure: Readmission rate
timeFrame: 30 days
Other outcomes:
Locations:
city: Beijing
country: China
facility: China-Japan Friendship hospital
state: Beijing
Study officials:
affiliation: China-Japan Friendship Hospital
name: Bin Cao
role: STUDY_DIRECTOR
References: