InfluenzaPhase 3NCT05474755
To Assess the Efficacy of GP681 Tablet Versus Placebo in Patients With Acute Uncomplicated Influenza Virus Infection
A Phase 3 study testing GP681 40mg in people with Influenza, run by Jiangxi Qingfeng Pharmaceutical Co. Ltd. at 1 site in China.
Trial 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 Read more about this study
- Who is it for?
- Ages 5 to 65 years
- Conditions the study is for
- Influenza
- What is being tested?
- GP681 40mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 591 participants
- Where
- 1 siteChina
- Study dates
- 28 Jul 2022to 31 Oct 2023
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 5 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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.
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- 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
- Known history of alcohol abuse (Average weekly intake of alcohol is more than 14 units alcohol (1 units ≈ 360 mL beer, or 45 mL spirits with 40% content, or 150 mL wine) or drug abuse at screening;
- Patients weighing <20 kg.
- Has received any investigational agents or devices for any indication within 30 days prior to Screening.
- Patients who, in the opinion of the Investigator, may not be qualified or suitable for the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multi-center, Randomized, Double-blind, Placebo-controlled Phase III Clinical Study on the Safety and Efficacy of GP681 Tablets in the Treatment of Acute Uncomplicated Influenza
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
- Being tested
- GP681 40mg, Placebo
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GP681 40mgDrug
2X20mg tablets taken orally
PlaceboDrug
Placebo tablets matching GP681 40mg
| Study group | Role | What they receive |
|---|---|---|
| GP681 40mg | Experimental | Patients in the GP681 40mg group will receive a single oral dose of GP681 tablet 40mg with 240mL water. Receives: 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to Day 15
Secondary outcomes (15)
Time to Cessation of Viral Shedding Determined by Virus Titer
Defined as the time between the initiation of the study treatment and first time when the virus titer was below the limit of detection.
Measured: Up to Day7
Percentage of Participants With Positive Influenza Virus RNA by RT-PCR at Each Time Point
The percentage of patients positive for virus RNA by RT-PCR.
Measured: Days 2, 3, 5,7
Percentage of Participants With Positive Influenza Virus Titer at Each Time Point
Virus titer was quantified from nasopharyngeal swabs by tissue culture methods.
Measured: Days 2, 3, 5,7
Area Under the Concentration (AUC) of virus RNA by RT-PCR and AUC of virus titer
AUC of the viral load by RT-PCR and AUC of viral titer measured from baseline to Day 7
Measured: Up to Day 7
Change From Baseline in Virus RNA (RT-PCR) at Each Time Point
Nasopharyngeal swabs were obtained for viral quantitation.
Measured: Days 2, 3, 5,7
Change in the total score of 7 influenza symptoms
The composite symptom score is the total score of the 7 influenza symptoms(Sum of symptom scores) as assessed by the participant, and ranges from 0 to 21.
Measured: Up to Day15
Time to alleviation of each influenza symptom
Defined as the time from the start of treatment to the start of the time period when the individual symptom was assessed by the participant as 0 (None) or 1 (Mild) for a duration of at least 21.5 hours.
Measured: Up to Day15
Time to Alleviation of the Four Systemic Symptoms in Participants
Defined as the time between the initiation of the study treatment to the time when all 4 systemic symptoms (headache, fever or chills, muscle or joint pain, and fatigue) were assessed by the participant as 0 (None) or 1 (Mild) for a duration of at least 21.5 hours.
Measured: Up to Day15
Time to Alleviation of the Three Respiratory Symptoms in Participants
Defined as the time from the start of study treatment to the time when all 3 respiratory symptoms (cough, sore throat and nasal congestion) were assessed by the participant as absent (0) or mild (1) for at least 21.5 hours
Measured: Up to Day15
Percentage of Participants Reporting Normal Temperature at Each Time Point
Defined as the percentage of patients whose axillary temperature dropped to less than 37.3 degree Celsius [ºC] after the initiation of study treatment
Measured: 12, 24, 48, 72, 96,120, 144 and168 hours after the initial dose of study treatment
Time to Resolution of Fever
Defined as the time between the initiation of the study treatment and the resolution of fever. The resolution of fever was defined as the time when the participant's self-measured axillary temperature became less than 37.3ºC and was maintained at less than 37.3ºC for a duration of at least 21.5 hours.
Measured: Up to Day15
Incidence of Influenza-related Complications
Defined as the percentage of subjects in the analysis population who experience each influenza-related complication (hospitalization, death, sinusitis, bronchitis, otitis media, and pneumonia) as an adverse event after the initiation of the study treatment.
Measured: Up to Day15
Proportion of Patients and Frequency in Combination Use of Acetaminophen
The proportion of patients who use acetaminophen in the duration of the study.
Measured: Up to Day15
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. The return to normal activities of daily life is defined as the time when the subject assesses his/her activities as 10. Subjects with a baseline self-rated daily activity score of 10 are not included in this analysis.
Measured: Up to Day15
Change from baseline in health-related quality of life according to EuroQol 5 dimensions 5 (EQ-5D-5L) questionnaire
The EQ-5D-5L is a self-reported health status questionnaire that consists of six questions used to calculate a health utility score for use in health economic analysis. There are two components to the EQ-5D-5L: a five-item health state profile that assesses mobility, self-care, usual activities, pain/discomfort, and anxiety/depression used to obtain an Index Utility Score, as well as a visual analogue scale (VAS) that measures health state. The VAS is designed to rate the participant's current health state on a scale from 0 to 100, where 0 represents the worst imaginable health state and 100 represents the best imaginable health state.
Measured: Up to Day15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2022
- Study start28 Jul 2022
- Primary completion25 Apr 2023
- Study completion31 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InfluenzaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 591 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangxi Qingfeng Pharmaceutical Co. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bin Cao, phd, Principal investigator, China-Japan Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05474755
- Sponsor's protocol ID
- GP681-202201
- Status last verified
- Nov 2023
- First submitted
- 23 Jul 2022
- Last updated
- 14 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 39775042
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Randomized, Double-blind, Placebo-controlled Phase III Clinical Study on the Safety and Efficacy of GP681 Tablets in the Treatment of Acute Uncomplicated Influenza
- ClinicalTrials.gov ID
- NCT05474755
- Acronym / sponsor ID
- GP681-202201
- Conditions
- Influenza
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 591 participants (actual)
- Lead sponsor
- Jiangxi Qingfeng Pharmaceutical Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- 28 Jul 2022 (actual)
- Primary completion
- 25 Apr 2023 (actual)
- Study completion
- 31 Oct 2023 (actual)
- First posted
- 26 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GP681 40mg | Experimental | Drug: GP681 40mgPatients in the GP681 40mg group will receive a single oral dose of GP681 tablet 40mg with 240mL water. |
| placebo group | Placebo comparator | Drug: PlaceboPatients in the Placebo group will receive a single oral dose of GP681 Simulant 40mg with 240mL water. |
Who may qualify
- Ages
- 5 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (12 listed)
- 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:
- The time interval between the onset of symptoms and random enrollment is 48 hours or less. The onset of symptoms is defined as either:
- 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.
Key exclusion criteria (19 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GP681 40mg2X20mg tablets taken orally | Drug | GP681 40mg |
| PlaceboPlacebo tablets matching GP681 40mg | Drug | placebo group |
Primary outcome
Time to alleviation of influenza symptoms
Time frame: Up to Day 15
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.
15 secondary outcomes
Time to Cessation of Viral Shedding Determined by Virus Titer
Time frame: Up to Day7
Percentage of Participants With Positive Influenza Virus RNA by RT-PCR at Each Time Point
Time frame: Days 2, 3, 5,7
Percentage of Participants With Positive Influenza Virus Titer at Each Time Point
Time frame: Days 2, 3, 5,7
Area Under the Concentration (AUC) of virus RNA by RT-PCR and AUC of virus titer
Time frame: Up to Day 7
Change From Baseline in Virus RNA (RT-PCR) at Each Time Point
Time frame: Days 2, 3, 5,7
Change in the total score of 7 influenza symptoms
Time frame: Up to Day15
Time to alleviation of each influenza symptom
Time frame: Up to Day15
Time to Alleviation of the Four Systemic Symptoms in Participants
Time frame: Up to Day15
Time to Alleviation of the Three Respiratory Symptoms in Participants
Time frame: Up to Day15
Percentage of Participants Reporting Normal Temperature at Each Time Point
Time frame: 12, 24, 48, 72, 96,120, 144 and168 hours after the initial dose of study treatment
Time to Resolution of Fever
Time frame: Up to Day15
Incidence of Influenza-related Complications
Time frame: Up to Day15
Proportion of Patients and Frequency in Combination Use of Acetaminophen
Time frame: Up to Day15
Time to Return to Normal Activities of Daily Life
Time frame: Up to Day15
Change from baseline in health-related quality of life according to EuroQol 5 dimensions 5 (EQ-5D-5L) questionnaire
Time frame: Up to Day15
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2023.
- Derived from this study: PubMed 39775042Wang 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bin Cao, phd principal investigator
China-Japan Friendship Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing GP681 40mg in people with Influenza, run by Jiangxi Qingfeng Pharmaceutical Co. Ltd. at 1 site in China.
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 12 inclusion and 19 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: finished, as of the sponsor's last update on 14 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Time to alleviation of influenza symptoms (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 NCT05474755, which also lists 1 linked publication.
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 14 Nov 2023.