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



Status:Recruiting
Conditions:Influenza
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:13 - 85
Updated:3/22/2019
Start Date:January 3, 2018
End Date:May 1, 2020
Contact:Study Contact
Email:JNJ.CT@sylogent.com
Phone:844-434-4210

Use our guide to learn which trials are right for you!

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 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.

This double-blind (neither researchers nor participants know what treatment participant is
receiving) study will evaluate efficacy/safety of pimodivir in combination with SOC treatment
versus placebo in combination with SOC treatment in adolescent, adult, and elderly
hospitalized participants with influenza A infection. The study will be conducted in 3
phases: screening phase, double-blind treatment period of 5 days (with the possibility to
extend treatment period by 5 days for participants who will enter an optional double-blind
extension treatment arm), and post treatment follow-up period of 23 days. Study evaluations
will include efficacy, pharmacokinetic, biomarkers, safety and tolerability. The duration of
participation in study for each participant is 28 days, except for participants receiving
extended treatment, for whom study duration will be up to 33 days.

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 (NEWS) 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
We found this trial at
38
sites
Augusta, Georgia 30912
?
mi
from
Augusta, GA
Click here to add this to my saved trials
1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
?
mi
from
Birmingham, AL
Click here to add this to my saved trials
5050 Anthony Wayne Dr
Detroit, Michigan 48201
(313) 577-2424
Wayne State University Founded in 1868, Wayne State University is a nationally recognized metropolitan research...
?
mi
from
Detroit, MI
Click here to add this to my saved trials
291 Campus Dr
Stanford, California 94305
(650) 725-3900
Stanford University School of Medicine Vast in both its physical scale and its impact on...
?
mi
from
Stanford, CA
Click here to add this to my saved trials
2401 Avenida Lainez
Bahia Blanca, 8000
?
mi
from
Bahia Blanca,
Click here to add this to my saved trials
733 North Broadway
Baltimore, Maryland 21205
(410) 955-3182
Johns Hopkins University School of Medicine Johns Hopkins Medicine (JHM), headquartered in Baltimore, Maryland, is...
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
22 S Greene St
Baltimore, Maryland 21201
(410) 328-8667
University of Maryland Medical Center Founded in 1823 as the Baltimore Infirmary, the University of...
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
Brandon, Florida 33511
?
mi
from
Brandon, FL
Click here to add this to my saved trials
Bronx, New York 10467
?
mi
from
Bronx, NY
Click here to add this to my saved trials
Butte, Montana 59701
?
mi
from
Butte, MT
Click here to add this to my saved trials
Charleston, South Carolina 29414
?
mi
from
Charleston, SC
Click here to add this to my saved trials
303 East Superior Street
Chicago, Illinois 60611
?
mi
from
Chicago, IL
Click here to add this to my saved trials
?
mi
from
Columbia, MO
Click here to add this to my saved trials
?
mi
from
Columbus, OH
Click here to add this to my saved trials
Columbus, Ohio 43215
?
mi
from
Columbus, OH
Click here to add this to my saved trials
1801 Inwood Rd
Dallas, Texas 75390
(214) 645-3300
University of Texas Southwestern Medical Center UT Southwestern is an academic medical center, world-renowned for...
?
mi
from
Dallas, TX
Click here to add this to my saved trials
?
mi
from
Detroit, MI
Click here to add this to my saved trials
2799 W Grand Blvd
Detroit, Michigan 48202
(313) 916-2600
Henry Ford Hospital Founded in 1915 by auto pioneer Henry Ford and now one of...
?
mi
from
Detroit, MI
Click here to add this to my saved trials
Fresno, California 93702
?
mi
from
Fresno, CA
Click here to add this to my saved trials
Jonesboro, Arkansas 72401
?
mi
from
Jonesboro, AR
Click here to add this to my saved trials
?
mi
from
Kalamazoo, MI
Click here to add this to my saved trials
?
mi
from
Lima, OH
Click here to add this to my saved trials
2801 Atlantic Avenue
Long Beach, California 90806
?
mi
from
Long Beach, CA
Click here to add this to my saved trials
Miami, Florida 33155
?
mi
from
Miami, FL
Click here to add this to my saved trials
259 1st St
Mineola, New York 11501
(516) 663-0333
Winthrop University Hospital Founded in 1896 by a group of local physicians and concerned citizens,...
?
mi
from
Mineola, NY
Click here to add this to my saved trials
Minneapolis, Minnesota 55455
?
mi
from
Minneapolis, MN
Click here to add this to my saved trials
Newark, New Jersey 07102
?
mi
from
Newark, NJ
Click here to add this to my saved trials
Royal Oak, Michigan 48073
?
mi
from
Royal Oak, MI
Click here to add this to my saved trials
?
mi
from
Sacramento, CA
Click here to add this to my saved trials
Saint Louis, Missouri 63110
?
mi
from
Saint Louis, MO
Click here to add this to my saved trials
Santa Rosa Beach, Florida 32459
?
mi
from
Santa Rosa Beach, FL
Click here to add this to my saved trials
Seattle, Washington 98105
?
mi
from
Seattle, WA
Click here to add this to my saved trials
?
mi
from
Seattle, WA
Click here to add this to my saved trials
Teaneck, New Jersey 07666
?
mi
from
Teaneck, NJ
Click here to add this to my saved trials
Tomball, Texas 77375
?
mi
from
Tomball, TX
Click here to add this to my saved trials
Troy, Michigan 48085
?
mi
from
Troy, MI
Click here to add this to my saved trials
Wenatchee, Washington 98801
?
mi
from
Wenatchee, WA
Click here to add this to my saved trials
55 N Lake Ave
Worcester, Massachusetts 01655
(508) 856-8989
Univ of Massachusetts Med School As the commonwealth's only public medical school, we take seriously...
?
mi
from
Worcester, MA
Click here to add this to my saved trials