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

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Influenza A

In brief

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.

Key facts

Study ID

NCT03376321

Run by

Janssen Research & Development, LLC

People needed

334

Starts

2018-01-03

Expected to finish

2020-04-30

Last updated by the study team

2025-02-04

Who can join

Age: 13 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Nea Baptist Clinic — Jonesboro, Arkansas, United States
• UCSF Fresno — Fresno, California, United States
• Miller Children's at Long Beach Medical Center — Long Beach, California, United States
• Stanford University School of Medicine — Stanford, California, United States
• Destin Pulmonary Critical Care, PLLS. — Santa Rosa Beach, Florida, United States
• Northside Hospital — Atlanta, Georgia, United States
• Augusta University — Augusta, Georgia, United States
• Anne Arundel Medical Center — Annapolis, Maryland, United States
• University Of Maryland Medical Center — Baltimore, Maryland, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Wayne State Univ School of Medicine — Detroit, Michigan, United States
• Henry Ford Hospital — Detroit, Michigan, United States
• Wayne State University — Detroit, Michigan, United States
• Western Michigan University Homer Stryker M.D. School of Medicine Center for Clinical Research — Kalamazoo, Michigan, United States
• William Beaumont Hospital — Royal Oak, Michigan, United States
• William Beaumont Hospital — Troy, Michigan, United States
• Regents of the University of Minnesota — Minneapolis, Minnesota, United States
• Washington University — St Louis, Missouri, United States
• Mercury Street Medical Group, PLLC — Butte, Montana, United States
• Saint Michaels Medical Center — Newark, New Jersey, United States
• Holy Name Medical Center — Teaneck, New Jersey, United States
• Montefiore Medical Center PRIME — The Bronx, New York, United States
• UC Health LLC — Cincinnati, Ohio, United States
• Rhode Island Hospital — Providence, Rhode Island, United States
• University of Alabama at Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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