Health Condition 1: B978- Other viral agents as the cause ofdiseases classified elsewhere
Conditions
Interventions
Intervention1: � Treatment Arm 1: pimodivir 600 mg twice daily (bid) for 5 days plus SOC treatment: Participants will receive pimodivir 600 milligram (mg) orally twice daily for 5 days (on Days
for participants who will receive only 1 dose of pimodivir on Day 1 [evening], dosing will continue until the morning of Day 6) along with Standard-of-Care (SOC) treatment. Participants who meet all t
for participants who will receive only 1 dose of placebo on Day 1 [evening], dosing will continue until the morning of Day 6) along with SOC treatment. Participants who meet all treatment extension cr
Sponsors
Janssen Research Development LLC
Eligibility
Inclusion criteria
Inclusion criteria: -Tested positive for influenza A infection after the onset of symptoms using a polymerase chain reaction (PCR) based 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 -Having a peripheral capillary oxygen saturation less than 94 percent on room air. Participants with known pre-influenza SpO2 leass than 94 percent must have an SpO2 decline greater than or equal to 3% from pre-influenza SpO2 -Having a screening/baseline National Early Warning Score (NEWS) of greater than equal to 4
Exclusion criteria
Exclusion criteria: -Severely immunocompromised in the opinion of the investigator (for example, cluster of differentiation 4 plus [CD4 plus] count less than 200 cells per cubic millimeter, absolute neutrophil count less tahn 750cubic milimetre, 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Participants Clinical Status Assessed by Hospital Recovery ScaleTimepoint: Day 6 | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to Clinical ResponseTimepoint: Up to 33 days (up to 28 days if no treatment extension);Time to Influenza Viral NegativityTimepoint: Up to Day 19 (up to Day 14, if no treatment extension);Time to Reach Maximum Plasma Concentration (tmax) of PimodivirTimepoint: Day 1: 1.5 to 6 hours post dose; Day 3: predose; Day 5: pre-dose and 1.5 to 6 hours post dose; and Day 6: 12 hours post dose;Time to Respiratory ResponseTimepoint: Up to 33 days (up to 28 days if no treatment extension);Time to Return to Daily ActivitiesTimepoint: Up to 33 days (up to 28 days if no treatment extension);Trough Plasma Concentration (Ctrough) of PimodivirTimepoint: Day 3: pre-dose; Day 5: pre-dose; and Day 6: 12 hours post dose;Viral Load Over TimeTimepoint: Up to Day 19 (up to Day 14, if no treatment extension);Virologic Response by Baseline Viral Resistance to Pimodivir/Other AntiviralsTimepoint: Up to Day 19 (up to Day 14, if no treatment extension);Acceptability of the Pimodivir Formulation in Adolescents as Measured by a Taste QuestionnaireTimepoint: Days 1 and 5 (evening) or 6 (morning);Acceptability of the Pimodivir Formulation in Adolescents as Measured by a Swallowability QuestionnaireTimepoint: Days 1 and 5 (evening) or 6 (morning);Area Under the Plasma Concentration-Time Curve from Time Zero to 12 Hours After Dosing AUC(0-12)Timepoint: Day 1: 1.5 to 6 hours post dose; Day 3: predose; Day 5: pre-dose and 1.5 to 6 hours post dose; and Day 6: 12 hours post dose;Length of Hospital StayTimepoint: Up to 33 days (up to 28 days if no treatment extension);Length of Time in the Intensive Care Unit (ICU)Timepoint: Up to 33 days (up to 28 days if no treatment extension);Maximum Plasma Concentration (Cmax) of pimodivirTimepoint: Day 1: 1.5 to 6 hours post dose; Day 3: predose; Day 5: pre-dose and 1.5 to 6 hours post dose; and Day 6: 12 hours post dose;Number of Participants not Hospitalized at Day 6Timepoint: Day 6;Number of Participants Rec | — |
Countries
Argentina, Australia, Belgium, Brazil, Bulgaria, Chile, Czech Republic, France, Germany, Hungary, India, Israel, Italy, Latvia, Lithuania, Malaysia, Mexico, Netherlands, New Zealand, Peru, Poland, Republic of Korea, Romania, Russian Federation, Singapore, Slovakia, South Africa, Spain, Sweden, Taiwan, Thailand, Turkey, United Kingdom, United States of America, Viet Nam
Contacts
Public ContactSuneela
Quintiles Research (India) Private Limited
Outcome results
None listed