This pilot randomized controlled trial (RCT) will investigate the clinical impact ofMyxovirus Resistance Protein A (MxA)-guided antiviral treatment versus standard treatmentin patients with respiratory viral infections.
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
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.
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
China-Japan Friendship hospital
Beijing, Beijing, China
Investigator: Bin Cao
Contact: 8610-84206264
caobin_ben@163.com
Yeming Wang, M.D.
+86 84206264
wwyymm_love@163.com
Mengwei Yan, M.D.
yanmengwei_happy@126.com
Bin Cao, Study Director
China-Japan Friendship Hospital