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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GP681 tablet 40mg | Experimental | atients in the GP681 tablet 40mg group will receive a single oral dose of GP681 tablet 40mg with water. |
|
| Placebo group | Placebo Comparator | Patients in the Placebo group will receive a single oral dose of GP681 Simulant 40mg with water. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GP681 40mg | Drug | 2X20mg tablets taken orally |
| |
| GP681 Simulant |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | up to Day 10 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Index patients(IPs)
Household contacts of index patients:
Exclusion Criteria:
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.).
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:
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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Siyuan Xi | Contact | 84206250 | ZRYHYYGCPEC@126.com | |
| Bin Cao, phd | Contact | 13911318339 | caobin_ben@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shulan (Hang Zhou) Hospital | Recruiting | Hanzhou | China |
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| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
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| Drug |
Placebo tablets matching GP681 40mg |
|
| 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. | 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):
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. | 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:
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. | 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. | 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. | 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 | Up to Day 10 |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |