NCT06668025

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
86

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 30, 2024

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 31, 2024

Completed
1 month until next milestone

Study Start

First participant enrolled

December 12, 2024

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 28, 2026

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 12, 2026

Completed
Last Updated

March 4, 2026

Status Verified

March 1, 2026

Enrollment Period

1.1 years

First QC Date

October 30, 2024

Last Update Submit

March 2, 2026

Conditions

Respiratory Viral InfectionsInfluenzaSARS CoV-2

Outcome Measures

Primary Outcomes (1)

  • 30-Day recurrence rate

    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.

    30 days

Secondary Outcomes (9)

  • 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

  • +4 more secondary outcomes

Study Arms (2)

MxA group

EXPERIMENTAL

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

Other: MxA testsOther: MxA feedbackOther: Follow-up at Day 30

Control group

ACTIVE COMPARATOR

Telephone Visit at Day 30

Other: Follow-up at Day 30

Interventions

MxA testsOTHER

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.

MxA group
MxA feedbackOTHER

MxA results will be reported to the attending physician within 4 hours, along with MxA-based antiviral treatment guidelines.

MxA group
Follow-up at Day 30OTHER

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.

Control groupMxA group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ≥ 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

China-Japan Friendship hospital

Beijing, Beijing Municipality, 100029, China

Location

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Study Officials

  • Bin Cao

    China-Japan Friendship Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 30, 2024

First Posted

October 31, 2024

Study Start

December 12, 2024

Primary Completion

January 28, 2026

Study Completion

February 12, 2026

Last Updated

March 4, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will share

IPD used in the results publication will be shared.

Shared Documents
ICF, CSR

Locations

CN(1)