A PHASE 3 RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PIMODIVIR IN COMBINATION WITH THE STANDARD-OF-CARE TREATMENT IN ADOLESCENT, ADULT, AND ELDERLY HOSPITALIZED PATIENTS WITH INFLUENZA A INFECTION.

Janssen Research & Develoment, LLC,0 个研究点目标入组 0 人开始时间: 2018年8月29日最近更新: 2023年9月4日

试验速览

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•Male or female, 13 to 85 years of age, inclusive. Note: Adolescent subjects (13-17 years) will be enrolled in selected countries and study sites consistent with local regulations.
•Tested positive for influenza A infection after the onset of symptoms using a polymerase chain reaction (PCR)-based molecular diagnostic assay.
•Requires hospitalization to treat influenza infection and/or to treat complications of influenza infection (eg, radiological signs of lower respiratory tract disease, septic shock, central nervous system [CNS] involvement, myositis, rhabdomyolysis, acute exacerbation of chronic kidney disease, severe dehydration, myocarditis, pericarditis, ischemic heart disease, exacerbation of underlying chronic pulmonary disease, including asthma, chronic obstructive pulmonary disease [COPD], decompensation of previously controlled diabetes mellitus), including subjects admitted to the intensive care unit (ICU). Note: For the purpose of the protocol, subjects admitted under observation” status with an anticipated length of stay beyond 24 hours are eligible for enrollment.
•Enrollment and initiation of study drug treatment ≤96 hours after onset of influenza symptoms.
•Having an SpO2 <94% on room air. Subjects with known pre influenza SpO2 <94% must have an SpO2 decline ≥3% from pre-influenza SpO2.
•Having a screening/baseline NEWS of ≥4.

•Received more than 3 doses of influenza antiviral medication (eg, oseltamivir [OST] or zanamivir), or any dose of ribavirin within 2 weeks, prior to first study drug intake. Received intravenous (IV) peramivir more than one day prior to screening.
•Unwilling to undergo regular nasal mid-turbinate (MT) swabs or has any physical abnormality which limits the ability to collect regular nasal MT specimens.
•Unstable angina pectoris or myocardial infarction within 30 days prior to screening (inclusive).
•Presence of clinically significant heart arrhythmias, uncontrolled, unstable atrial arrhythmia, or sustained ventricular arrhythmia, or risk factors for Torsade de Pointes syndrome.
•Chronic hepatitis C infection undergoing antiviral therapy.
•Severely immunocompromised in the opinion of the investigator (eg, cluster of differentiation 4+ [CD4+] count <200 cells/mm3, absolute neutrophil count <750/mm3, first course of chemotherapy completed within 2 weeks prior to screening, history of stem cell transplant within 1 year prior to screening, any history of a lung transplant).

发起方

Janssen Research & Develoment, LLC,