Study to Assess the Prophylactic Efficacy and Safety of Sebaloxavir Marboxil Tablets/Oral Suspension for Influenza Prevention in Household Contacts Aged ≥2 Years.

Официальное название

A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Trial to Assess the Prophylactic Efficacy and Safety of Sebaloxavir Marboxil Tablets/Oral Suspension for Influenza Prevention in Household Contacts Aged ≥2 Years.

Обзор

This study is a randomized, double-blind, placebo-controlled phase III clinical trial. The trial participants include index participants (IP) and household contacts (HHC). A total of 536 index participants (the first person in the household diagnosed with influenza) and 858 household contacts (family members living with the index participant) are planned to be enrolled. After the index participants and their household contacts have signed informed consent form and passed screening eligibility, randomization will be performed at the household level in a 1:1 ratio, stratifying by the time from onset of the index participant's initial influenza symptoms to signing of informed consent form (\<24 hours, ≥24 hours), index participant's viral subtype (influenza A, influenza B), and household contact's age (\<12 years, ≥12 years). Household contacts will be assigned to either the Sebaloxavir marboxil group or the placebo group. The study objective is to compare the prophylactic efficacy and safety of Sebaloxavir marboxil tablets/oral suspension versus placebo in household contacts (HHCs).

Вмешательства

• Препарат Sebaloxavir marboxil
  Dosing Regimen for Household Contacts: Sebaloxavir marboxil tablets/oral suspension is administered based on age as follows: * 18 years: Single dose, Sebaloxavir marboxil tablets: 2 tablets; * 12 years and \<18 years: Single dose, Sebaloxavir marboxil tablets: 1 tablet; * 2 years and \<12 years: Single dose, Sebaloxavir marboxil oral suspension, administered according to body weight.
• Препарат Placebo
  Dosing Regimen for Household Contacts: Household contacts will receive the placebo of Sebaloxavir marboxil tablets/oral suspension based on age as follows: * 18 years: Single dose, placebo of Sebaloxavir marboxil tablets: 2 tablets; * 12 years and \<18 years: Single dose, placebo of Sebaloxavir marboxil tablets: 1 tablet; * 2 years and \<12 years: Single dose, placebo of Sebaloxavir marboxil oral suspension, administered according to body weight.

Первичные конечные точки

• The percentage of household contacts (HHCs) with PCR-positive influenza virus infection accompanied by fever (axillary temperature ≥37.5°C) and at least one additional influenza symptom (e.g., nasal congestion, sore throat, cough) after dosing. [Срок оценки: From day1 up to day10]

Вторичные конечные точки (6)

• Percentage of HHCs with PCR-positive influenza virus infection but no influenza symptoms after dosing. [Срок оценки: From day1 up to day10]
• Percentage of HHCs with PCR-positive influenza virus infection accompanied by fever (axillary temperature ≥37.5°C) or at least one other influenza symptom after dosing. [Срок оценки: From day1 up to day10]
• Time from dosing to PCR-positive influenza virus infection accompanied by fever or at least one other influenza symptom after dosing. [Срок оценки: From day1 up to day10]
• Time from dosing to meeting the primary endpoint criteria (influenza virus infection accompanied by fever [axillary temperature ≥37.5°C] and at least one other influenza symptom). [Срок оценки: From day1 up to day10]
• Percentage of households with at least one HHC achieving the primary endpoint criteria after dosing, relative to all households. [Срок оценки: From day1 up to day10]
• Incidence of all adverse events (AEs) and serious adverse events (SAEs) [Срок оценки: Time Frame: From day1 up to day15]

Критерии участия

Index Participants:

Inclusion Criteria：

• 1\. The index participant (aged ≥18 years), or the index participant (aged <18 years) together with their legal guardian, understands and voluntarily provides written informed consent form (ICF). The index participant must be ≥1 year of age at the time of ICF signing, with no gender restriction.
• 2\. The index participant must be the first case of influenza virus infection in the household during the current influenza season.
• 3\. The index participant must have a positive result from a rapid influenza diagnostic test (RIDT) or polymerase chain reaction (PCR) assay.
• 4\. At the time of HHC randomization, the interval from the onset of the index participant's initial influenza symptoms to informed consent must be ≤48 hours. Symptom onset is defined as: first axillary temperature ≥37.5°C, or the presence of at least one other influenza symptom.
• 5\. The index participant must not have used any anti-influenza antiviral medications (including traditional Chinese medicines or Western medicines) since symptom onset, and must be willing to receive oseltamivir phosphate treatment after signing informed consent form.

Exclusion Criteria：

• 1\. Participants who are diagnosed with bacterial or other non-influenza virus infections at screening requiring systemic antibacterial or antiviral treatment;
• 2\. Participants with suspected hypersensitivity to the active ingredients or excipients of oseltamivir phosphate oral suspension/capsules.

Household contact:

Inclusion Criteria：

• 1\. Aged ≥2 years at the time of randomization, with no gender restriction;
• 2\. Has been living in the same household with the index participant for at least 48 hours at the time of randomization;
• 3\. Is able to reside with the index participant from screening/randomization through Day 10 (must live in the same household with the index participant for at least 7 days);
• 4\. Tests negative by rapid influenza diagnostic test (RIDT) or polymerase chain reaction (PCR);
• 5\. Meets all of the following criteria and is judged by the investigator to have no influenza virus infection:

• Axillary temperature <37°C at screening;
• No influenza-related symptoms at screening (such as nasal congestion, sore throat, cough, myalgia or arthralgia, fatigue, headache, chills/sweating, or other influenza symptoms assessed by the investigator);
• 6\. The HHC is ≥18 years of age, or the HHC is <18 years of age and together with their parent(s)/legal guardian(s) understands and voluntarily signs the informed consent form (ICF), and agrees to comply with all study procedures, including completion of diary cards (the guardian may assist in assessment/completion).
• 7\. The HHC must sign the informed consent form (ICF) within 24 hours after the index participant signs the ICF;
• 8\. The HHC and their partner must agree to practice complete abstinence or use effective contraceptive measures from screening through 3 months after the end of study drug administration.

Exclusion Criteria：

• 1\. Participants with suspected hypersensitivity to the active pharmaceutical ingredients or excipients of the investigational product;
• 2\. Participants whose household contacts or other family members (excluding the index participant) have been diagnosed with influenza within 3 months before randomization;
• 3\. Participants who have been cohabiting with other family members exhibiting influenza-like symptoms (axillary temperature ≥37.5°C, nasal congestion, sore throat, cough, myalgia/arthralgia, fatigue, headache, chills/sweating, or other influenza symptoms as assessed by the investigator) other than on the screening day;
• 4\. Participants requiring systemic (oral or injectable) or intranasal antipyretic/analgesic agents, corticosteroids, or immunosuppressants (those using topical preparations are allowed);
• 5\. Participants who have received an influenza vaccine within 6 months prior to screening;
• 6\. Participants who have taken anti-influenza Chinese or Western medications within 30 days prior to screening, including but not limited to neuraminidase inhibitors, hemagglutinin inhibitors, M2 ion channel blockers, cap-dependent endonuclease (CEN) inhibitors, and heat-clearing/detoxifying Chinese herbal medicines, such as oseltamivir, zanamivir, peramivir, laninamivir, umifenovir, favipiravir, rimantadine, amantadine, arbidol, nitazoxanide, baloxavir, Lianhua Qingwen capsules/granules, Jinhua Qinggan granules\*, etc.
• 7\. Participants with active infection or requiring systemic anti-infective treatment at screening (topical therapy for mild skin infections is allowed).
• 8\. Participants with other respiratory viral infections.
• 9\. Participants with difficulty swallowing study medication or a history of gastrointestinal disorders that may significantly impair drug absorption, including but not limited to reflux esophagitis, chronic diarrhea, inflammatory bowel disease, intestinal tuberculosis, gastrinoma, short bowel syndrome, or post-gastrectomy.
• 10\. Participants with severe underlying comorbidities, defined as Grade 3 or higher per the Common Terminology Criteria for Adverse Events (CTCAE) Version 6.0.
• 11\. Immunocompromised participants, including those with malignancies, history of organ or bone marrow transplantation, HIV infection, or use of immunosuppressants within the previous 3 months.
• 12\. HHCs requiring long-term use of aspirin- or salicylate-containing products, defined as daily regular use for more than 14 consecutive days.
• 13\. Participants with suspected or confirmed alcohol abuse (defined as weekly consumption of >14 units of alcohol; 1 unit = 360 mL beer, 45 mL of 40% spirits, or 150 mL of 12% wine) or history of drug abuse.
• 14\. Participants who have participated in another interventional clinical trial of a drug or medical device within 30 days before screening.
• 15\. Women who have a positive pregnancy test result or are currently lactating.
• 16\. Participants with any other conditions that, in the judgment of the investigator, would preclude enrollment in the study.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Профилактика

Центры проведения

Китай · 1 центр

• China Japan friendship hospital — Пекин

Идентификаторы

NCT: NCT07730346 · ZX-7101A-212

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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