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

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

NCT03381196

Run by

Janssen Research & Development, LLC

People needed

553

Starts

2018-01-21

Expected to finish

2020-08-24

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…

• 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)

You may not qualify if…

• 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)

Where it is running

• Alabama Clinical Therapeutics, LLC — Birmingham, Alabama, United States
• Cahaba Research Inc — Birmingham, Alabama, United States
• Scottsboro Quick Care Clinic — Scottsboro, Alabama, United States
• SC Clinical Research Inc. — California City, California, United States
• Research Center of Fresno Inc — Fresno, California, United States
• Allied Clinical Research — Gold River, California, United States
• Innovative Clinical Research Inc — Harbor City, California, United States
• Om Research LLC — Lancaster, California, United States
• Ark Clinical Research — Long Beach, California, United States
• Miller Children's Hospital — Long Beach, California, United States
• Downtown LA Research Center, Inc — Los Angeles, California, United States
• California Allergy & Asthma Medical Group Inc. — Los Angeles, California, United States
• Adam D. Karns, MD — Los Angeles, California, United States
• Lucita M. Cruz Md Inc — Norwalk, California, United States
• Asclepes Research — Panorama City, California, United States
• Center for Clinical Trials LLC — Paramount, California, United States
• Benchmark Research — Sacramento, California, United States
• Medical Associates Research Group, Inc. — San Diego, California, United States
• San Diego Sports Medicine & Family Health Center — San Diego, California, United States
• West Coast Clinical Research, LLC — San Ramon, California, United States
• Stanford University — Stanford, California, United States
• Lynn Institute — Colorado Springs, Colorado, United States
• Complete Family Care — Northglenn, Colorado, United States
• Paradigm Clinical Research Centers, Inc. — Wheat Ridge, Colorado, United States
• University of Alabama at Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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