To Assess the Efficacy of GP681 Tablet Versus Placebo in Patients With Acute Uncomplicated Influenza Virus Infection

NCT05474755 | Completed Phase 3

• 1 other identifier: GP681-202201
• Study Type: interventional
• Target: 591
• Locations: 1 country
• Sites: 1

Brief Summary

This study will evaluate the efficacy, safety, and population pharmacokinetics of a single, oral dose of GP681 compared with placebo in patients aged 12 to 65 years with acute uncomplicated influenza virus infection

Conditions

Influenza

Outcome Measures

Primary Outcomes (1)

• Time to alleviation of influenza symptoms

  Participants assessed the severity of seven influenza-associated symptoms (cough, sore throat, headache, nasal congestion, feverishness or chills, muscle or joint pain, and fatigue) on a 4-point scale (with 0 indicating no symptoms, 1 mild symptoms, 2 moderate symptoms, and 3 severe symptoms). Defined as the time from the start of treatment until the patient's body temperature returns to normal and all 7 flu symptoms (cough, sore throat, headache, nasal congestion, fever or chills, muscle or joint pain, fatigue) have alleviated (scoring 0 or 1 point) for at least 21.5 hours.

  Up to Day 15

Secondary Outcomes (15)

• Time to Cessation of Viral Shedding Determined by Virus Titer

  Up to Day7

• Percentage of Participants With Positive Influenza Virus RNA by RT-PCR at Each Time Point

  Days 2, 3, 5,7

• Percentage of Participants With Positive Influenza Virus Titer at Each Time Point

  Days 2, 3, 5,7

• Area Under the Concentration (AUC) of virus RNA by RT-PCR and AUC of virus titer

  Up to Day 7

• Change From Baseline in Virus RNA (RT-PCR) at Each Time Point

  Days 2, 3, 5,7

Study Arms (2)

GP681 40mg

EXPERIMENTAL

Patients in the GP681 40mg group will receive a single oral dose of GP681 tablet 40mg with 240mL water.

Drug: GP681 40mg

placebo group

PLACEBO COMPARATOR

Patients in the Placebo group will receive a single oral dose of GP681 Simulant 40mg with 240mL water.

Drug: Placebo

Interventions

GP681 40mg DRUG

2X20mg tablets taken orally

GP681 40mg

Placebo DRUG

Placebo tablets matching GP681 40mg

placebo group

Eligibility Criteria

• Age: 5 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female patients aged≥5 to≤65 years at the time of signing the informed consent form.
• Patients with a diagnosis of influenza confirmed by all of the following:
• Positive Influenza rapid antigen test or Polymerase chain reaction (PCR), and;
• Fever (axillary temperature ≥37.3℃) in the predose examinations or \> 4 hours after dosing of antipyretics if they were taken,and;
• At least one of the following systemic symptoms and respiratory symptoms respectively associated with influenza are present with a severity of moderate or greater:
• Systemic symptoms: headache, fever or chills, muscle or joint aches, fatigue;
• Respiratory system symptoms: cough, sore throat, nasal congestion.
• The time interval between the onset of symptoms and random enrollment is 48 hours or less. The onset of symptoms is defined as either:
• Time of the first increase in body temperature (axillary temperature ≥37.3℃)
• Time when the patient experiences at least one systemic or respiratory symptom related to influenza
• Subjects of child-bearing potential who agree to use a highly effective method of contraception for 1 month after drug withdrawal.
• Subjects and/or their guardian who are willing to provide written informed consent and consent to participate in the study, able to understand the study and comply with all study procedures, including patient health diary records.

You may not qualify if:

• History of allergic reactions attributed to GP681 or any of the ingredients of its formulation.
• Patients with influenza virus infection requiring inpatient treatment;
• Known history of dysphagia or any gastrointestinal disease that affects drug absorption (including but not limited to reflux esophagitis, chronic diarrhea, inflammatory bowel disease, intestinal tuberculosis, gastrinoma, short bowel syndrome, stomach after subtotal resection, etc.).
• Treatment with anti-influenza virus drugs (oseltamivir, zanamivir, peramivir, favipiravir, arbidol, baloxavir marboxil, amantadine, or rimantadine) within 2 weeks before screening, or immunization with influenza vaccine within 6 months prior to enrollment;
• Investigator suspects or confirms that patients with bronchitis, pneumonia, pleural effusion or interstitial disease through chest imaging examination.
• Acute respiratory infection, otitis media or sinusitis within 2 weeks prior to Screening.
• Patients with concurrent bacterial or (non-influenza) infections requiring systemic antimicrobial and/or antiviral therapy at the pre-dose examinations.
• Positive nucleic acid test for COVID-19 in screening period.
• Patients with severe or uncontrollable underlying diseases, including blood disorders, severe chronic obstructive pulmonary disease(COPD), liver disorders, kidney disorders, chronic congestive heart failure(NYHA III-IV), mental disorders;
• Immunodeficiency,including malignant tumor, organ or marrow transplant, human immunodeficiency virus \[HIV\] infection, or patients receiving immunosuppressant therapy 3 months prior to enrollment.
• Concomitant therapy with aspirin or salicylic acid.
• Morbid obesity (Body mass index \[BMI\]≥30kg/m2)
• Women who are pregnant, breastfeeding, or have a positive pregnancy test at the predose examinations. The following female patients who have documentation of either a or b below do not need to undergo a pregnancy test at the predose examinations:
• Postmenopausal women (defined as cessation of regular menstrual periods for 2 years or more and aged more than 50 years old)
• Women who are surgically sterile by hysterectomy, bilateral oophorectomy, or tubal ligation

Sponsors & Collaborators

• Jiangxi Qingfeng Pharmaceutical Co. Ltd.: lead

Study Sites (1)

The First People's Hospital of Wenling

Wenling, Zhejiang, 317500, China

Location

Related Publications (1)

• Wang Y, Wang H, Zhang Y, Ma A, Liu D, Li X, Yang G, Deng M, Wang S, Liu Y, Liu C, Ge F, Wang S, Yu Y, Feng G, Xiao Z, Li X, Sun Y, Chen X, Cao Z, Ding Y, Wu X, Wei J, Cao B. Single-dose suraxavir marboxil for acute uncomplicated influenza in adults and adolescents: a multicenter, randomized, double-blind, placebo-controlled phase 3 trial. Nat Med. 2025 Feb;31(2):639-646. doi: 10.1038/s41591-024-03419-3. Epub 2025 Jan 7.

  PMID: 39775042 DERIVED

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Study Officials

• Bin Cao, phd

  China-Japan Friendship Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 23, 2022
• First Posted: July 26, 2022
• Study Start: July 28, 2022
• Primary Completion: April 25, 2023
• Study Completion: October 31, 2023
• Last Updated: November 14, 2023

Record last verified: 2023-11

Locations

CN (1)