Last updated on May 2019

A Study to Evaluate the Efficacy and Safety of Pimodivir in Combination With the Standard-of-Care Treatment in Adolescent Adult and Elderly Non-Hospitalized Participants With Influenza A Infection Who Are at Risk of Developing Complications

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Influenza A
  • Age: Between 13 - 85 Years
  • Gender: Male or Female

Inclusion Criteria:

  • Present to the clinic with symptoms suggestive of a diagnosis of acute influenza and have at least 1 respiratory symptom and at least 1 systemic symptom, both scored as at least "moderate" if the symptom did not pre-exist before influenza onset, or scored worse than usual if the symptom pre-existed as determined by subject's ratings on Module 1 of the Flu-iiQ and the Pre-existing Symptom Questionnaire in the ePRO device. Symptoms must include the following by category: a) Respiratory symptoms: cough, sore throat, nasal congestion b) Systemic symptoms: headache, body aches or pain, feverishness, fatigue
  • Tested positive for influenza A infection after the onset of symptoms, using a rapid influenza diagnostic test (RIDT) or, if available, a polymerase chain reaction (PCR)-based or other rapid molecular diagnostic assay
  • Not be in need of hospitalized medical care at screening. Emergency room or hospital observation status for an anticipated duration of less than (<)24 hours is not considered hospitalization as long as a determination of the need for hospitalization has not been made
  • Enrollment and initiation of study drug treatment less than or equal to (<=)72 hours after onset of influenza symptoms
  • Participants 13 to 65 years of age, inclusive must also have at least 1 of the following: a) Cardiovascular or cerebrovascular disease (including congenital heart disease, chronic heart failure, coronary artery disease, or stroke; excluding isolated hypertension); b) Chronic lung disease (for example, asthma, chronic obstructive lung disease [COPD] or cystic fibrosis); c) Weakened immune system due to disease or medication (for example, participants with human immunodeficiency virus [HIV], cancer, or chronic liver or kidney disease [presence of kidney damage for >3 months, defined by structural or functional abnormalities of the kidney, with or without decreased GFR manifested by: pathological abnormalities; OR markers of kidney damage, including abnormalities in the composition of the blood or urine or abnormalities in imaging tests], or participants taking chronic systemic steroids)

Exclusion Criteria:

  • Received more than (>)1 dose of influenza antiviral medication (for example, oseltamivir [OST] or zanamivir), or any dose of ribavirin within 2 weeks, prior to first study drug intake, or received intravenous (IV) peramivir >1 day prior to screening
  • 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 (for example, known cluster of differentiation 4 plus [CD4+] count <200 cells per cubic millimeter [cells/mm^3], absolute neutrophil count <750/mm^3, first course of chemotherapy completed within 2 weeks prior to screening, history of stem cell transplant within 1 year prior to screening, history of a lung transplant)

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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