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Active, not recruitingNCT07229807Updated Dec 16, 2025

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

A Phase 3 interventional study of ZSP1273 and Oseltamivir in Influenza a, sponsored by Guangdong Raynovent Biotech Co., Ltd. Active, not recruiting at 1 site in China. Open to participants aged 2 Years to 11 Years. Per ClinicalTrials.gov, last updated 2025-12-16.

Sponsored by Guangdong Raynovent Biotech Co., Ltd · Phase 3, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Dec 2025, 9 months ago, but the record still lists the study as active, not recruiting.
Phase
Phase 3
Study type
Interventional
Enrollment
119
Allocation
Randomized
Ages
2 Years to 11 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Influenza a
03

In context

Lead sponsor

Guangdong Raynovent Biotech Co., Ltd is the lead sponsor of 35 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
2 Years to 11 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
119 participants (estimated)

Study arms

  • Experimental
    ZSP1273

    Drug: ZSP1273

  • Active comparator
    Oseltamivir

    Drug: Oseltamivir

Interventions

  • DrugZSP1273

    Oral

  • DrugOseltamivir

    Oral

06

What researchers measure

Primary outcomes

  1. Time to Alleviation of Symptoms

    Participants assessed the severity of influenza-associated symptoms

    Time frame: DAY1~DAY15

Secondary outcomes

  1. Plasma concentrations of ZSP1273

    Time frame: DAY1~5

  2. Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

    Time frame: DAY1~15

07

Study locations

1 site
  • Beijing Children Hospital
    Beijing, China
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 16, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07229807
Lead sponsor
Guangdong Raynovent Biotech Co., Ltd
Responsible party
Sponsor
First posted
Nov 17, 2025
Start date
Nov 22, 2025
Primary completion
Dec 17, 2025 (estimated)
Completion
Dec 31, 2025 (estimated)
Last update
Dec 16, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.

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