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InfluenzaPhase 3NCT07113392

A Study to Evaluate the Safety, Efficacy and Pharmacokinetics of Suraxavir Marboxil for Suspension

A Phase 3 study testing Suraxavir Marboxil and Oseltamivir in people with Influenza, run by Jiangxi Kvvit Pharmaceutical Co., Ltd..

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record
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Trial summary

This study will evaluate the safety, efficacy and pharmacokinetics of Suraxavir Marboxil compared with oseltamivir in Pediatric Patients (2 to <12 Years) with Uncomplicated Influenza. Read more about this study

Who is it for?
Ages 2 to 12 years
Conditions the study is for
Influenza
What is being tested?
Suraxavir Marboxil and Oseltamivir
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
144 participants
Where
No sites listed yet
Study dates
1 Aug 2025to 1 Aug 2026
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 2 to 12 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Male or female participants aged 2 to 12 years (≥2 years and <12 years).
  • body weight≥10 kg at screening.
  • Diagnosed with influenza virus infection based on the following criteria:
  • Positive rapid antigen test (RAT) result from a throat or nasal swab for influenza virus (rapid nucleic acid tests or other rapid molecular diagnostic tests are also acceptable); and
  • Fever at screening (tympanic temperature ≥38.0°C or axillary temperature ≥37.5°C). If antipyretics were taken, fever must be present >1 hour after administration, or If fever subsided (tympanic <38.0°C or axillary <37.5°C) after antipyretic use, fever must have recurred >4 hours after administration; and
  • Presence of at least one moderate or more severe respiratory symptom at screening (including cough, and/or nasal congestion or rhinorrhea).
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  • Time interval between the onset of illness symptoms and enrollment is ≤48 hours.
  • Onset of illness: defined as the time of the first temperature increase (tympanic temperature ≥38.0°C or axillary temperature ≥37.5°C) or time of first appearance (or caregiver observation) of at least one respiratory symptom associated with influenza virus infection.
  • The participant's legal guardian agrees to the child's participation in the clinical study and signs the informed consent form (ICF). Participants aged ≥8 years must also voluntarily sign the ICF.
  • The investigator assesses that the participant and/or the caregiver can comply with the protocol requirements, follow-up visits, and complete all study procedures and evaluations (e.g., completing the diary card).

Who cannot join

  • Known hypersensitivity to the active ingredient or excipients of the investigational product.
  • Patients diagnosed with severe or critical influenza at screening: (1) Severe influenza cases were defined by the presence of one or more of the following conditions: a. Dyspnea and/or tachypnea without fever: >30 breaths/min (age >5 years), >40 breaths/min (age 2-5 years).b. Altered mental status (e.g., lethargy, agitation, seizures).c. Severe vomiting/diarrhea with moderate-to-severe dehydration.d. Concurrent pneumonia.e. Significant exacerbation of pre-existing comorbidities.(2) Critical influenza cases were defined by the presence of one or more of the following conditions: a. Respiratory failure.b. Acute necrotizing encephalopathy.c. Septic shock.d. Multiorgan dysfunction.e. Other life-threatening conditions requiring intensive care.
  • Note: Based on "Expert Consensus on Diagnosis and Treatment of Influenza in Children (2020 Edition)".
  • History of gastrointestinal diseases affecting drug absorption (e.g., reflux esophagitis, chronic diarrhea, inflammatory bowel disease, intestinal tuberculosis, gastrinoma, short bowel syndrome, post-gastrectomy).
  • Bronchitis, pleural effusion, or interstitial pneumonia suspected by investigator or confirmed by chest imaging.
  • Use of anti-influenza antiviral drugs within two weeks before screening (e.g., neuraminidase inhibitors [oseltamivir, zanamivir, peramivir], cap-dependent endonuclease inhibitors [baloxavir marboxil], hemagglutinin inhibitors [arbidol], M2 inhibitors [amantadine, rimantadine], or other NMPA-approved anti-influenza agents).
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  • Clinically relevant abnormal results in physical examination, 12-lead ECG, vital signs, hematology, clinical biochemistry, or urinalysis at screening, which in the investigator's judgment may pose a risk to the participant's safety, affect the study results, or impact the participant's ability to complete the study.
  • Acute respiratory infection (excluding current influenza), otitis media, or sinusitis within 2 weeks pre-screening.
  • Co-infection requiring systemic antibiotics or other systemic therapy at screening.
  • Known/suspected active primary/secondary immunodeficiency (including HIV infection, hematologic malignancies causing severe immunodeficiency).
  • Known or suspected congenital abnormalities of the heart or lungs, or severe primary diseases affecting the cardiovascular, hepatic, renal, or hematopoietic systems, or evidence of active liver disease, including but not limited to jaundice or AST/ALT levels exceeding two times the upper limit of normal (ULN) at screening.
  • Positive serology for hepatitis B surface antigen or a history of hepatitis B infection at screening.
  • (Note: participants with HBV vaccination history and no prior HBV infection are exempt from this exclusion after medical history review).
  • History of mental illness, intellectual disability, substance abuse, or other adverse conditions (e.g., inability to read, understand, or write) that, in the investigator's judgment, may limit participation in the study.
  • Influenza vaccination within 6 months pre-screening or planned during the study. (Note: Vaccination history must be verified by medical history review).
  • Participation in any interventional clinical trial (drug/device) within 30 days pre-screening.
  • Intolerance to skin puncture, fainting at the sight of blood or needles, or poor venous access for blood collection at screening.
  • Any other condition deemed unsuitable by the investigator.

About this study

Official title: A Multicenter, Randomized, Double-Blind, Active-Controlled Clinical Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Suraxavir Marboxil for Suspension in Pediatric Patients (2 to <12 Years) With Uncomplicated Influenza

This study will evaluate the safety, efficacy and pharmacokinetics of Suraxavir Marboxil compared with oseltamivir in Pediatric Patients (2 to <12 Years) with Uncomplicated Influenza.

Conditions
Influenza
Being tested
Suraxavir Marboxil, Oseltamivir
Medical subject headings
Influenza, Human

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Suraxavir MarboxilDrug

    Suraxavir Marboxil will be administered as oral suspension: 40 mg (if weight ≥ 32 kg), or 20 mg (if weight <32 kg).

  • OseltamivirDrug

    Oseltamivir will be administered as oral granules: 30 mg (if weight ≤15 kg), 45 mg (if weight > 15 kg to ≤ 23 kg), 60 mg (if weight > 23 kg to ≤ 40 kg) or 75 mg (if weight > 40 kg), twice daily (BID) for 5 days.

Study groups in NCT07113392
Study groupRoleWhat they receive
Suraxavir MarboxilExperimentalParticipants will receive a single oral dose of Suraxavir Marboxil on Day 1 based on body weight.
Receives: Drug: Suraxavir Marboxil
OseltamivirActive comparatorParticipants will receive oseltamivir twice a day for 5 days based on body weight.
Receives: Drug: Oseltamivir

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants with Adverse Events (AEs)

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention.

    Measured: up to Day 15

Secondary outcomes (13)

  1. Time to Alleviation of Symptoms (TTAS)

    Defined as the time from treatment initiation until meeting all criteria below for ≥21.5 consecutive hours:

    1. Return to afebrile status (tympanic temperature ≤37.2°C);
    2. Absence/Mild severity for all respiratory symptoms (cough, nasal congestion, rhinorrhea) on the Canadian Acute Respiratory Illness and Flu Scale (CARIFS);
    3. "Yes" response to: "Has your child resumed normal daily activities as before illness?" in the Daily Activity Questionnaire.

    Measured: up to Day 15

  2. Time to Viral Clearance

    Time from treatment initiation until first undetectable viral titer (below the lower limit of quantification, LLOQ).

    Measured: up to Day 6

  3. Viral Clearance Rate

    Proportion of participants with viral titers below LLOQ at D2, D3 (if applicable), and D6 (if applicable).

    Measured: Days 2, 3,6

  4. Proportion of patients with influenza viral RNA positivity (by Q-PCR) and measurable viral titers at each time point(D2, D3 if applicable, D6 if applicable).

    The percentage of patients positive for virus RNA by Q-PCR. Virus titer was quantified from nasopharyngeal swabs by tissue culture methods.

    Measured: Days 2, 3,6

  5. Area Under the Concentration (AUC) of virus RNA by Q-PCR and AUC of virus titer

    AUC of the viral load by Q-PCR and AUC of viral titer measured from baseline to Day 6

    Measured: Up to Day 6

  6. Change From Baseline in Virus RNA (Q-PCR) at Each Time Point

    Nasopharyngeal swabs were obtained for viral quantitation.

    Measured: Days 2, 3,6

  7. Time to return to normal activities of daily life

    Defined as the time between the initiation of the study treatment and the return to normal activities of daily life.

    Measured: Up to Day15

  8. Time to Resolution of Individual Symptoms

    Time until absence/mild severity (CARIFS 16-item scale) for individual symptoms, sustained ≥21.5h.

    Measured: Up to Day15

  9. Time to Resumption of Normal Daily Activities

    Time until "Yes" response to the Daily Activity Questionnaire.

    Measured: Up to Day15

  10. Incidence of Influenza-Related Complications

    Including hospitalization, death, sinusitis, bronchitis, otitis media, and radiologically confirmed pneumonia.

    Measured: Up to Day15

  11. Palatability Assessment of Suraxavir Marboxil using Visual Analog Scale (VAS)

    Acceptability of taste assessed by 100-mm Visual Analog Scale (VAS) where 0 = "Very bad", 20 = "Bad", 50 = "Neutral", 80 = "Good", 100 = "Very good". Outcome reported as proportion of subjects with VAS score ≥50 (acceptable threshold) .

    Measured: Day1

  12. Grittiness Assessment of Suraxavir Marboxil using Visual Analog Scale (VAS)

    Perception of grittiness (grainy texture) assessed by 100-mm Visual Analog Scale (VAS) where 0 = "Severe grittiness", 20 = "Grittiness", 50 = "Slight grittiness", 80 = "No grittiness", 100 = "Smooth texture". Outcome reported as proportion of subjects with VAS score ≥50 (acceptable threshold) .

    Measured: Day1

  13. Pharmacokinetic (PK) Endpoints

    Plasma concentrations of Suraxavir Marboxil and its primary metabolite Suraxavir

    Measured: Up to Day6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Aug 2025
  2. Study start1 Aug 2025 (estimated)
  3. Primary completion1 Aug 2026 (estimated)
  4. Study completion1 Aug 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
144 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07113392
Sponsor's protocol ID
GP681-S-202501
Status last verified
Aug 2025
First submitted
23 Jul 2025
Last updated
8 Aug 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Suraxavir Marboxil and Oseltamivir in people with Influenza, run by Jiangxi Kvvit Pharmaceutical Co., Ltd..

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 8 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants with Adverse Events (AEs) (time frame: up to Day 15). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07113392.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2025.

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