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Efficacy and Safety of ZSP1273 in Children 2-11 Years Old With Influenza A

NCT ID: NCT07229807

Last Updated: 2025-12-16

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

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

119 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-11-22

Study Completion Date

2025-12-31

Brief Summary

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This trial is conducted in China. The aim of the trial is to investigate safety and efficacy of ZSP1273 granules

Detailed Description

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Conditions

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Influenza a

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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ZSP1273

Group Type EXPERIMENTAL

ZSP1273

Intervention Type DRUG

Oral

Oseltamivir

Group Type ACTIVE_COMPARATOR

Oseltamivir

Intervention Type DRUG

Oral

Interventions

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ZSP1273

Oral

Intervention Type DRUG

Oseltamivir

Oral

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Participants and their guardians who are able to understand the study and comply with all study procedures, and willing to provide written informed consent/assent prior to the predose examinations appropriately.
2. Male or female participants aged ≥ 2 to ≤11 years at the time of signing the informed consent form.
3. Participants with a diagnosis of influenza virus infection confirmed by all of the following:

1. Positive rapid antigen test (RAT) for influenza with nasal or throat swabs;
2. The time interval between the onset of symptoms and enrollment is 48 hours or less;
3. Fever ≥ 38ºC (axillary temperature); and at least one following respiratory symptoms associated with influenza virus infection is present

Exclusion Criteria

1. Participants with severe influenza virus infection；
2. Participants with any medical history in gastrointestinal that interferes with the absorption of drugs；
3. Immunodeficiency,including malignant tumor,organ or marrow transplant,human immunodeficiency virus \[HIV\] infection,or patients receiving immunosuppressant therapy 3 months prior to enrollment；
4. Have received any other investigational products within 3 months prior to dosing；
5. Positive urine pregnancy test；
6. Participants with concurrent infections requiring antimicrobial therapy；
7. Participants who are considered inappropriate for the study by the investigator.
Minimum Eligible Age

2 Years

Maximum Eligible Age

11 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Guangdong Raynovent Biotech Co., Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Beijing Children Hospital

Beijing, , China

Site Status

Countries

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China

Other Identifiers

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ZSP1273-25-20

Identifier Type: -

Identifier Source: org_study_id