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Study Protocol NCT03376321 Janssen Research & Development * Clinical Protocol 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 Protocol 63623872FLZ3001; Phase 3 AMENDMENT 2 JNJ-63623872-ZCD Pimodivir *Janssen Research & Development is a global organization that operates through different legal entities in various countries. Therefore, the legal entity acting as the sponsor for Janssen Research & Development studies may vary, such as, but not limited to Janssen Biotech, Inc.; Janssen Products, LP; Janssen Biologics, BV; Janssen-Cilag International NV; Janssen Pharmaceutica NV; Janssen, Inc; Janssen Sciences Ireland UC; or Janssen Research & Development, LLC. The term “sponsor” is used throughout the protocol to represent these various legal entities; the sponsor is identified on the Contact Information page that accompanies the protocol. This study will be conducted under US Food & Drug Administration IND regulations (21 CFR Part 312). EudraCT NUMBER: 2017-002156-84 Status: Approved Date: 11 June 2019 Prepared by: Janssen Research & Development, a division of Janssen Pharmaceutica NV EDMS number: EDMS-ERI-121941709, 10.0 GCP Compliance: This study will be conducted in compliance with Good Clinical Practice, and applicable regulatory requirements. Confidentiality Statement The information in this document contains trade secrets and commercial information that are privileged or confidential and may not be disclosed unless such disclosure is required by applicable law or regulations. In any event, persons to whom the information is disclosed must be informed that the information is privileged or confidential and may not be further disclosed by them. These restrictions on disclosure will apply equally to all future information supplied to you that is indicated as privileged or confidential. 1 Status: Approved, Date: 11 June 2019 JNJ-63623872-ZCD Pimodivir Clinical Protocol 63623872FLZ3001 Amendment 2 TABLE OF CONTENTS TABLE OF CONTENTS ............................................................................................................................... 2 LIST OF ATTACHMENTS............................................................................................................................ 5 LIST OF IN-TEXT FIGURES ........................................................................................................................ 5 PROTOCOL AMENDMENTS....................................................................................................................... 6 SYNOPSIS.................................................................................................................................................. 10 TIME AND EVENTS SCHEDULES ............................................................................................................ 22 1. TIME AND EVENTS SCHEDULE – DURING HOSPITALISATION (UP TO DISCHARGE)................. 22 2. TIME AND EVENTS SCHEDULE – AFTER DISCHARGE FROM HOSPITAL..................................... 26 3. TIME AND EVENTS SCHEDULE – DURING HOSPITALIZATION (UP TO DISCHARGE), FOR PATIENTS WHO ENTERED THE OPTIONAL DOUBLE-BLIND EXTENSION TREATMENT ARM............................................................................................................................ 28 4. TIME AND EVENTS SCHEDULE – AFTER DISCHARGE FROM HOSPITAL, FOR PATIENTS WHO HAD ENTERED THE OPTIONAL DOUBLE-BLIND EXTENSION TREATMENT ARM ........ 30 ABBREVIATIONS ...................................................................................................................................... 32 DEFINITIONS OF TERMS.......................................................................................................................... 33 1. INTRODUCTION................................................................................................................................ 34 1.1. Background .................................................................................................................................... 34 1.2. Standard-of-care ............................................................................................................................ 41 1.3. Overall Rationale for the Study...................................................................................................... 41 1.4. Benefits and Risks Management ................................................................................................... 42 1.4.1. Known Benefits of Pimodivir....................................................................................................... 42 1.4.2. Potential Benefits of Pimodivir.................................................................................................... 42 1.4.3. Known Risks of Pimodivir ........................................................................................................... 42 1.4.4. Potential Risks of Pimodivir ........................................................................................................ 43 1.4.5. Overall Benefit/Risk Assessment ............................................................................................... 45 2. OBJECTIVES AND HYPOTHESIS ................................................................................................... 46 2.1. Objectives and Endpoints .............................................................................................................. 46 2.1.1. Objectives ................................................................................................................................... 46 2.1.2. Endpoints.................................................................................................................................... 47 2.2. Hypothesis ..................................................................................................................................... 50 3. STUDY DESIGN AND RATIONALE ................................................................................................. 50 3.1. Overview of Study Design.............................................................................................................. 50 3.2. Study Design Rationale.................................................................................................................. 53 4. SUBJECT POPULATION.................................................................................................................. 54 4.1. Inclusion Criteria ............................................................................................................................ 54 4.2. Exclusion Criteria ........................................................................................................................... 57 4.3. Treatment Extension Criteria ......................................................................................................... 59 4.4. Prohibitions and Restrictions ......................................................................................................... 59 5. TREATMENT ALLOCATION AND BLINDING................................................................................. 59 6. DOSAGE AND ADMINISTRATION .................................................................................................. 60 2 Approved, Date: 11 June 2019 JNJ-63623872-ZCD Pimodivir Clinical Protocol 63623872FLZ3001 Amendment 2 7. TREATMENT COMPLIANCE............................................................................................................ 63 8. PRESTUDY AND CONCOMITANT THERAPY ................................................................................ 63 9. STUDY EVALUATIONS .................................................................................................................... 64 9.1. Study Procedures........................................................................................................................... 64 9.1.1. Overview..................................................................................................................................... 64 9.1.2. Screening Phase ........................................................................................................................ 64 9.1.3. Double-blind Treatment Phase................................................................................................... 66 9.1.4. Double-blind Extension Phase ................................................................................................... 67 9.1.5. Post-treatment Phase (Follow-up).............................................................................................. 68 9.1.6. After Discharge From the Hospital ............................................................................................. 68 9.2. Efficacy........................................................................................................................................... 68 9.2.1. Evaluations ................................................................................................................................. 68 9.2.1.1. Hospital Recovery Scale Assessment..................................................................................... 68 9.2.1.2. Complications of Influenza ...................................................................................................... 71 9.2.1.3. Patient-reported
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