MxA-Guided Antiviral Treatment in Respiratory Viral Infections

NCT ID: NCT06668025

Last Updated: 2025-02-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-12

Study Completion Date

2025-11-30

Brief Summary

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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

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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

Conditions

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Respiratory Viral Infections Influenza SARS CoV-2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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

Group Type EXPERIMENTAL

MxA tests

Intervention Type OTHER

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 feedback

Intervention Type OTHER

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

Follow-up at Day 30

Intervention Type OTHER

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 group

Telephone Visit at Day 30

Group Type ACTIVE_COMPARATOR

Follow-up at Day 30

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

MxA feedback

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

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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China-Japan Friendship Hospital

OTHER

Sponsor Role collaborator

Chinese Academy of Medical Sciences

OTHER

Sponsor Role collaborator

Capital Medical University

OTHER

Sponsor Role lead

Responsible Party

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Bin Cao

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Bin Cao

Role: STUDY_DIRECTOR

China-Japan Friendship Hospital

Locations

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China-Japan Friendship hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yeming Wang, M.D.

Role: CONTACT

+86 84206264

Mengwei Yan, M.D.

Role: CONTACT

Facility Contacts

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Bin Cao

Role: primary

8610-84206264

Other Identifiers

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2023-I2M-C&T-B-119

Identifier Type: -

Identifier Source: org_study_id

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