Flu influenza A
Conditions
Interventions
• Treatment Arm 1: pimodivir 600 mg twice daily (bid) for 5 days + SOC treatment
• Treatment Arm 2: pimodivir placebo bid for 5 days + SOC treatment
Sponsors
Janssen-Cilag
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: • Male or female, 13 to 85 years of age, inclusive. Note: Adolescent subjects (13-17 years) will be enrolled in selected countries and study sites consistent with local regulations.;• 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-iiQTM and the Pre-existing Symptom Questionnaire in the ePRO device. Symptoms must include the following by category: respiratory symptoms: cough, sore throat, nasal congestion; 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 PCR-based molecular diagnostic assay. ;• Not be in need of hospitalized medical care at screening. Emergency room or hospital observation status for <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
Exclusion criteria
Exclusion criteria: • Received more than 1 dose of influenza antiviral medication (eg, oseltamivir [OST] or zanamivir), or any dose of ribavirin within 2 weeks, prior to first study drug intake, or received intravenous (IV) peramivir more than 1 day prior to screening.;• Unwilling to undergo regular nasal mid-turbinate (MT) swabs or has any physical abnormality which limits the ability to collect regular nasal MT specimens.;• 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.;• Severely immunocompromised in the opinion of the investigator (eg, known cluster of differentiation 4+ [CD4+] count
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is the time to resolution of influenza-related symptoms as assessed by the PRO measure Flu-iiQTM. The resolution of influenza-related symptoms is defined as the beginning of the 24 hour period that the 7 primary influenza symptom scores (cough, sore throat, headache, nasal congestion, feeling feverish, body aches and pains, fatigue) are at most mild or at least back to previous level of symptom severity in case the subject reported the symptom as pre-existing. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Safety and tolerability based on assessment of adverse events (AEs), clinical laboratory assessments, 12-lead electrocardiograms (ECGs) and vital signs. 2. The hospital admission rate 28 days after treatment initiation. 3. Incidence of complications associated with influenza after the start of study treatment. A blinded Adjudication Committee (AC) will be established to adjudicate AEs on predefined criteria for complications (pulmonary versus extrapulmonary, major versus minor, as well as infectious versus noninfectious complications). The AC will receive data on AEs, including medical assessments (eg chest X-ray results, lab results) and concomitant therapy of cases selected from the AEs. Details will be provided in an AC charter. 4. Time to resolution of each of the 10 individual influenza-related symptoms as assessed by the PRO measure Flu-iiQTM. The resolution of each influenza-related symptom is defined as the beginning of the 24- hour period when the influenza symptom score is at most mild or at least back to the previous level of symptom severity in case the subject reported the symptom as pre-existing. 5. Time to return to daily activities as assessed by the subject. 6. Time to resolution of fever. Resolution of fever is defined as a body temperature | — |
Countries
Netherlands
Outcome results
None listed