Influenza, Respiratory Viral Infections, SARS CoV-2
Conditions
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
Interventions
OTHERMxA 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.
OTHERMxA feedback
MxA results will be reported to the attending physician within 4 hours, along with MxA-based antiviral treatment guidelines.
OTHERFollow-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.
Sponsors
Capital Medical University
China-Japan Friendship Hospital
Chinese Academy of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 30-Day recurrence rate | 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
| Measure | Time frame | Description |
|---|---|---|
| Antiviral-days by day 30 | 30 days | Defined as the total number of days of antiviral treatment from randomization to the discontinuation of antiviral therapy by Day 30. |
| Length of hospital stay | 30 days | Defined as the total number of hospital days by Day 30. |
| 30-day mortality | 30 days | Defined as the proportion of patients who died by Day 30. |
| Incidence of mechanical ventilation | 30 days | Defined as the proportion of patients receiving mechanical ventilation by day 30. |
| Incidence of complications | 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. |
| ICU admission rate | 30 days | Defined as the incidence of transfer to the ICU within 30 days of enrollment for patients initially admitted to a general ward. |
| Readmission rate | 30 days | Defined as the incidence of readmission or additional medical visits within 30 days of enrollment for patients who have been discharged. |
| 30-day adverse outcomes | 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. |
| Total antiviral-days by day 30 | 30 days | Defined as the total number of days of antiviral treatment from admission to the discontinuation of antiviral therapy by Day 30. |
Countries
China
Contacts
STUDY_DIRECTORBin Cao
China-Japan Friendship Hospital
Outcome results
None listed