A Study to Evaluate the Efficacy and Safety of Pimodivir in Combination With the Standard-of-Care Treatment in Adolescent, Adult, and Elderly Hospitalized Participants With Influenza A Infection

The purpose of this study is to evaluate the clinical and virologic benefit of pimodivir in combination with Standard-of-Care (SOC) treatment compared to placebo in combination with SOC treatment.

Stanford is currently accepting patients for this trial.

Stanford Investigator(s):

Intervention(s):

  • drug: Pimodivir 600 mg
  • drug: Placebo
  • other: SOC Treatment

Eligibility


Inclusion Criteria:

   - 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 (for example, 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 participants
   admitted to the Intensive Care Unit (ICU)

   - Enrollment and initiation of study drug treatment less than or equal to (<=)96 hours
   after onset of influenza symptoms

   - Being on invasive mechanical ventilation or having a peripheral capillary oxygen
   saturation (SpO2) less than (<)94 percent (%) on room air during screening.
   Participants with known pre-influenza SpO2 <94% must have an SpO2 decline greater than
   or equal to (>=)3% from pre-influenza SpO2 during screening

   - Having a screening/baseline National Early Warning Score 2 (NEWS2) of >=4

Exclusion Criteria:

   - Received more than 3 doses of influenza antiviral medication (for example, oseltamivir
   [OST] or zanamivir), or any dose of ribavarin (RBV) within 2 weeks, prior to first
   study drug intake. Received intravenous (IV) peramivir more than one 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, any history of a lung transplant)

   - Known allergies, hypersensitivity, or intolerance to pimodivir or its excipients

Ages Eligible for Study

13 Years - 85 Years

Genders Eligible for Study

All

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Recruiting

Our research team includes physicians, residents, medical students, research assistants, and volunteers. Our research topics include medical imaging, device validation,  mobile application development, and pharmaceutical trials.  

Some of the Neuro-Opthalmic concerns we investigate include Multiple Sclerosis, Optic Neuritis, IIH, and ICP.