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Compares treatment options for Influenza
Official title Study to Assess the Efficacy and Safety of GP681 Versus Placebo for Postexposure Prophylaxis Against Influenza
ClinicalTrials.gov ID: NCT06574503
What this study is testing
What is GP681 40mg?
GP681 40mg is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for influenza.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 12 and older. Healthy volunteers may be eligible.
You may be able to join if
- 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.
You likely can't join if
- Household contacts of index patients:
- History of allergic reactions attributed to GP681 or any of the ingredients of its formulation.
- people with household members other than the index patient that was diagnosed with or strongly suspected to have influenza in the past 12 weeks.
- people with concurrent bacterial or other virus infections requiring systemic antimicrobial and/or antiviral therapy at the pre-dose examinations.
- people 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...
See the full eligibility criteria
- 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.
- Patients live in a household where all household contacts are expected to meet the key household contacts (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...
- 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.
- people who had lived with the index patient for 3 months or more prior to informed consent.
- people 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;
- people who have a body temperature (axillary) \< 37.3°C at Screening, and;
- people 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;
- people 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...
- Household contacts of index patients:
- History of allergic reactions attributed to GP681 or any of the ingredients of its formulation.
- people with household members other than the index patient that was diagnosed with or strongly suspected to have influenza in the past 12 weeks.
- people with concurrent bacterial or other virus infections requiring systemic antimicrobial and/or antiviral therapy at the pre-dose examinations.
- people 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...
- people who have any underlying diseases requiring systemic , treatment of antipyretics/analgesics, corticosteroids, or immunosuppressive agents.
- people with human immunodeficiency virus [HIV] infection.
- people 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...
- 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.
- people who, in the opinion of the Investigator, may not be qualified or suitable for the study.
The study team makes the final eligibility decision.
Where it's taking place
- Hanzhou, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 12 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hanzhou, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.