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 Infectio
- Conditions
- Fluinfluenza A10047438
- Registration Number
- NL-OMON48779
- Lead Sponsor
- Janssen-Cilag
- Brief Summary
Trial ended prematurely
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 26
* 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 or other rapid 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.
* Being on invasive mechanical ventilation or having an SpO2 <94% on
room air during screening. Subjects with known pre influenza SpO2 <94% must
have an SpO2 decline *3% from pre-influenza SpO2.
* Having a screening/baseline National Early Warning Score (NEWS2) of *4.
For a full list of inclusion criteria please refer to the protocol.
* 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.
* Known severe hepatic impairment (Child Pugh C cirrhosis) or chronic
hepatitis C infection undergoing hepatitis C antiviral therapy.
* Severely immunocompromised in the opinion of the investigator (eg,
known 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).
For a full list of exclusion criteria please refer to the protocol.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary Endpoint<br /><br>The primary endpoint is the hospital recovery scale as assessed on Day 6.</p><br>
- Secondary Outcome Measures
Name Time Method