InfluenzaPhase 3NCT06574503
Study to Assess the Efficacy and Safety of GP681 Versus Placebo for Postexposure Prophylaxis Against Influenza
A Phase 3 study testing GP681 40mg and GP681 Simulant in people with Influenza, run by Jiangxi Qingfeng Pharmaceutical Co. Ltd. at 1 site in China.
Trial summary
Index patients who are infected with influenza virus (Q-PCR positive) can be treated with anti-influenza drugs if their influenza symptoms onset was within 48 hours of screening. Read more about this study
- Who is it for?
- Ages 12 years and olderHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- GP681 40mg and GP681 Simulant
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 748 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2024to 30 Dec 2027
- 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 12 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Index patients(IPs)
- Male or female patients aged≥2 years at the time of signing the informed consent form.
- The first patient in a household with a diagnosis of influenza virus infection confirmed by all of the following in the influenza season:
- 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.
- Patients with onset of fever within 48 hours or less at informed consent.
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- Patients live in a household where all household contacts are expected to meet the key household contacts inclusion criteria (criteria 2, 3, \& 4).
- Patients 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.
- Household contacts of index patients:
- Male or female patients aged≥12 years at the time of signing the informed consent form.
- Household contacts who are able to provide informed consent within 24 hours or less from informed consent in index patients.
- Subjects who had lived with the index patient for 3 months or more prior to informed consent.
- Subjects who meet all of the following criteria and are judged not to have influenza virus infection by the investigator.
- Negative Influenza rapid antigen test or Polymerase chain reaction (PCR), and;
- Subjects who have a body temperature (axillary) < 37.3°C at Screening, and;
- Subjects who have no influenza like symptoms (cough, sore throat, headache, nasal discharge/nasal congestion, feverishness or chills, muscle or joint pain, and fatigue) at Screening.
- Household contacts intended for full study have not received influenza vaccine within 6 months prior to screening;
- 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
- Household contacts of index patients:
- History of allergic reactions attributed to GP681 or any of the ingredients of its formulation.
- Subjects with household members other than the index patient that was diagnosed with or strongly suspected to have influenza in the past 12 weeks.
- subjects with concurrent bacterial or other virus infections requiring systemic antimicrobial and/or antiviral therapy at the pre-dose examinations.
- Subjects who are unable to live with the index patient from Screening until Day 10.
- 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.).
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- Subjects who have any underlying diseases requiring systemic , treatment of antipyretics/analgesics, corticosteroids, or immunosuppressive agents.
- Subjects with human immunodeficiency virus [HIV] infection.
- Subjects with severe (Grade 3 or higher of Common Terminology Criteria for Adverse Events [CTCAE] ver. 5) underlying diseases.
- Treatment with anti-influenza virus drugs (oseltamivir, zanamivir, peramivir, favipiravir, abidol, baloxavir marboxil, amantadine, or rimantadine) within 2 weeks before screening.
- 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;
- 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 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
- Has received any investigational agents or devices for any indication within 30 days prior to Screening.
- Subjects 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. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shulan (Hang Zhou) Hospital
Hanzhou
Hainv Gao, 057156131318, Gaohainv@163.com
About this study
Official title: A Phase III, Multicenter, Randomized, Double-blind, Placebo-controlled, Clinical Efficacy and Safety Study of GP681 Tablets for Post-exposure Prophylaxis Against Influenza in Adults and Adolescents
Index patients who are infected with influenza virus (Q-PCR positive) can be treated with anti-influenza drugs if their influenza symptoms onset was within 48 hours of screening. Their eligible households will be randomized to either GP681 tablets or placebo if at least 1 household contacts have not received influenza vaccine with 6 months of screening and if all household contacts screen negative for influenza infection. The main endpoints are assessed based on multiple respiratory swabs, obtained from household contacts up to Day 10, and through the assessment of symptoms.
- Conditions
- Influenza
- Being tested
- GP681 40mg, GP681 Simulant
- 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
GP681 SimulantDrug
Placebo tablets matching GP681 40mg
| Study group | Role | What they receive |
|---|---|---|
| GP681 tablet 40mg | Experimental | atients in the GP681 tablet 40mg group will receive a single oral dose of GP681 tablet 40mg with 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 water. Receives: Drug: GP681 Simulant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of household members who are infected with influenza virus (Q-PCR positive), and present with fever and at least one influenza symptom with severity of moderate or severe in the period from Day 1 to Day 10.
Defined as the proportion of household members having body temperature (axillary)≥37.3°C, having symptom of influenza (respiratory symptoms or systemic symptoms) with a severity of "2, Moderate" or "3, Severe" assessed in the subject diary, and influenza virus positive assessed by Q-PCR.
Measured: up to Day 10
Secondary outcomes (7)
Proportion of household members who are infected with influenza virus (Q-PCR positive), and present with fever or at least one influenza symptom with severity of moderate or severe in the period from Day 1 to Day 10.
Defined as the proportion of household members having body temperature (axillary)≥37.3°C, or having symptom of influenza (respiratory symptoms or systemic symptoms) with a severity of "2, Moderate" or "3, Severe" assessed in the subject diary, and influenza virus positive assessed by Q-PCR.
Measured: up to Day10
Proportion of household members with influenza virus infection in the period from Day 1 to Day 10
Defined as the proportion of subjects having influenza virus positive assessed by RT-PCR regardless of body temperature or influenza symptoms.
Measured: up to Day10
Time from study treatment to the time when fever, at least one influenza symptom with severity of moderate or severe, and influenza virus infection were observed.
Defined as the later timepoint of the following (1) and (2):
- Timepoint when body temperature (axillary) rises first to " 37.3°C
- Timepoint when an influenza symptom was first assessed as"2, Moderate" or "3, Severe" in the subject diary.
If a household member does not have a body temperature (axillary) of "37.3°C or influenza symptom was not assessed as"2, Moderate" or "3, Severe" in the period from Day 1 to Day 10, the subject will be handled as a censored case.
Measured: up to Day10
Time from study treatment to the time when fever or at least one influenza symptom (respiratory symptom or systemic symptom), and influenza virus infection are observed.
Defined as the timepoint of the following (1) and (2), whichever is earlier:
- Timepoint when body temperature (axillary) rises first to " 37.3°C
- Timepoint when an influenza symptom was first assessed as"2, Moderate" or "3, Severe" in the subject diary.
If a subject does not have a body temperature (axillary) of "37.5°C and influenza symptoms (respiratory symptoms and systemic symptoms) were not assessed as 2, Moderate or 3, Severe in the period from Day 1 to Day 10, the subject will be handled as a censored case.
Measured: up to Day10
Proportion of asymptomatic influenza-infected (Q-PCR positive) household members in the period from Day 1 to Day 10
Defined as the proportion of household members having body temperature (axillary) < 37.5°C, influenza symptoms all assessed as 0, Absent or 1, Mild , and influenza virus positive assessed by Q-PCR.
Measured: Up to Day 10
Proportion of household members who are not infected with influenza virus (Q-PCR negative) and present with fever and at least one influenza symptom with severity of moderate or severe in the period from Day 1 to Day 10
Defined as the proportion of household members having body temperature (axillary) "37.3°C, having symptom of influenza (respiratory symptoms or systemic symptoms) with a severity of "2, Moderate" or "3, Severe" assessed in the subject diary, and influenza virus negative at all time points assessed by Q-PCR.
Measured: Up to Day 10
Proportion of household members who are infected with influenza virus (Q-PCR positive) in the period from Day 1 to Day 10, with virus subtype consistent with index patient
Defined as the proportion of household members who are infected with influenza virus (Q-PCR positive) in the period from Day 1 to Day 10，and the virus subtype of household members are consistent with index patient
Measured: Up to Day 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2024
- Study start1 Dec 2024
- Primary completion30 Jul 2027 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 748 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangxi Qingfeng Pharmaceutical Co. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06574503
- Sponsor's protocol ID
- GP681-202403
- Status last verified
- Dec 2024
- First submitted
- 25 Aug 2024
- Last updated
- 5 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Multicenter, Randomized, Double-blind, Placebo-controlled, Clinical Efficacy and Safety Study of GP681 Tablets for Post-exposure Prophylaxis Against Influenza in Adults and Adolescents
- ClinicalTrials.gov ID
- NCT06574503
- Acronym / sponsor ID
- GP681-202403
- Conditions
- Influenza
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 748 participants (estimated)
- Lead sponsor
- Jiangxi Qingfeng Pharmaceutical Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 30 Jul 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 28 Aug 2024 (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.
Index patients who are infected with influenza virus (Q-PCR positive) can be treated with anti-influenza drugs if their influenza symptoms onset was within 48 hours of screening. Their eligible households will be randomized to either GP681 tablets or placebo if at least 1 household contacts have not received influenza vaccine with 6 months of screening and if all household contacts screen negative for influenza infection. The main endpoints are assessed based on multiple respiratory swabs, obtained from household contacts up to Day 10, and through the assessment of symptoms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GP681 tablet 40mg | Experimental | Drug: GP681 40mgatients in the GP681 tablet 40mg group will receive a single oral dose of GP681 tablet 40mg with water. |
| Placebo group | Placebo comparator | Drug: GP681 SimulantPatients in the Placebo group will receive a single oral dose of GP681 Simulant 40mg with water. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (18 listed)
- Index patients(IPs)
- Male or female patients aged≥2 years at the time of signing the informed consent form.
- The first patient in a household with a diagnosis of influenza virus infection confirmed by all of the following in the influenza season:
- 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.
Key exclusion criteria (16 listed)
- History of allergic reactions attributed to GP681 or any of the ingredients of its formulation.
- Subjects with household members other than the index patient that was diagnosed with or strongly suspected to have influenza in the past 12 weeks.
- subjects with concurrent bacterial or other virus infections requiring systemic antimicrobial and/or antiviral therapy at the pre-dose examinations.
- Subjects who are unable to live with the index patient from Screening until Day 10.
- 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.).
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 tablet 40mg |
| GP681 SimulantPlacebo tablets matching GP681 40mg | Drug | Placebo group |
Primary outcome
Proportion of household members who are infected with influenza virus (Q-PCR positive), and present with fever and at least one influenza symptom with severity of moderate or severe in the period from Day 1 to Day 10.
Time frame: up to Day 10
Defined as the proportion of household members having body temperature (axillary)≥37.3°C, having symptom of influenza (respiratory symptoms or systemic symptoms) with a severity of "2, Moderate" or "3, Severe" assessed in the subject diary, and influenza virus positive assessed by Q-PCR.
7 secondary outcomes
Proportion of household members who are infected with influenza virus (Q-PCR positive), and present with fever or at least one influenza symptom with severity of moderate or severe in the period from Day 1 to Day 10.
Time frame: up to Day10
Proportion of household members with influenza virus infection in the period from Day 1 to Day 10
Time frame: up to Day10
Time from study treatment to the time when fever, at least one influenza symptom with severity of moderate or severe, and influenza virus infection were observed.
Time frame: up to Day10
Time from study treatment to the time when fever or at least one influenza symptom (respiratory symptom or systemic symptom), and influenza virus infection are observed.
Time frame: up to Day10
Proportion of asymptomatic influenza-infected (Q-PCR positive) household members in the period from Day 1 to Day 10
Time frame: Up to Day 10
Proportion of household members who are not infected with influenza virus (Q-PCR negative) and present with fever and at least one influenza symptom with severity of moderate or severe in the period from Day 1 to Day 10
Time frame: Up to Day 10
Proportion of household members who are infected with influenza virus (Q-PCR positive) in the period from Day 1 to Day 10, with virus subtype consistent with index patient
Time frame: Up to Day 10
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2024.
- Individual participant dataSharing planned: No
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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.
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 and GP681 Simulant 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 18 inclusion and 16 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: looking for participants now, as of the sponsor's last update on 5 Dec 2024. 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?
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?
Contact Siyuan Xi (84206250, ZRYHYYGCPEC@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of household members who are infected with influenza virus (Q-PCR positive), and present with fever and at least one influenza symptom with severity of moderate or severe in the period from Day 1 to Day 10. (time frame: up to Day 10). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Dec 2024.