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A Multicenter, Multi-Outbreak, Randomized, Controlled Safety And 2018 Ebola MCM RCT Protocol Page 1 of 92 IND#: 125530 CONFIDENTIAL 4 October 2019, version 7.0 A Multicenter, Multi-Outbreak, Randomized, Controlled Safety and Efficacy Study of Investigational Therapeutics for the Treatment of Patients with Ebola Virus Disease Short Title: 2018 Ebola MCM RCT Protocol Sponsored by: Office of Clinical Research Policy and Regulatory Operations (OCRPRO) National Institute of Allergy and Infectious Diseases 5601 Fishers Lane Bethesda, MD 20892 NIH Protocol Number: 19-I-0003 Protocol IND #: 125530 ClinicalTrials.gov Number: NCT03719586 Date: 4 October 2019 Version: 7.0 CONFIDENTIAL This document is confidential. No part of it may be transmitted, reproduced, published, or used by other persons without prior written authorization from the study sponsor and principal investigator. 2018 Ebola MCM RCT Protocol Page 2 of 92 IND#: 125530 CONFIDENTIAL 4 October 2019, version 7.0 KEY ROLES DRC Principal Investigator: Jean-Jacques Muyembe-Tamfum, MD, PhD Director-General, DRC National Institute for Biomedical Research Professor of Microbiology, Kinshasa University Medical School Kinshasa Gombe Democratic Republic of the Congo Phone: +243 898949289 Email: [email protected] Other International Investigators: see Appendix E Statistical Lead: Lori Dodd, PhD Biostatistics Research Branch, DCR, NIAID 5601 Fishers Lane, Room 4C31 Rockville, MD 20852 Phone: 240-669-5247 Email: [email protected] U.S. Principal Investigator: Richard T. Davey, Jr., MD Clinical Research Section, LIR, NIAID, NIH Building 10, Room 4-1479, Bethesda, MD 20892-1662 Phone: +1-301-496-8029 Email: [email protected] Data Coordinating Center: Clinical Trials Research Section Biostatistics Research Branch Division of Clinical Research, NIAID 5601 Fishers Lane, Room 4C31 Rockville, MD 20852 Federalwide assurance (FWA) numbers: 00005897 (NIH) 00025422 (Kinshasa School of Public Health) Protocol Development Team see Appendix E Steering Committee see Appendix E DSMB see Appendix E Medical Monitors: see Appendix E 2018 Ebola MCM RCT Protocol Page 3 of 92 IND#: 125530 CONFIDENTIAL 4 October 2019, version 7.0 Deleted: 10 TABLE OF CONTENTS Deleted: 15 Deleted: 16 KEY ROLES ................................................................................................................................... 2 Deleted: 16 TABLE OF CONTENTS ................................................................................................................ 3 Deleted: 16 PROTOCOL SUMMARY .............................................................................................................. 8 Deleted: 16 PRÉCIS ......................................................................................................................................... 13 1 BACKGROUND INFORMATION AND SCIENTIFIC RATIONALE ............................. 14 Deleted: 17 Background ....................................................................................................................... 14 Deleted: 18 Filoviruses ..................................................................................................................... 14 Deleted: 20 Transmission and Disease ............................................................................................. 14 Deleted: 20 Latest Outbreaks ........................................................................................................... 15 Deleted: 22 Therapy ......................................................................................................................... 16 Deleted: 22 RCT of ZMapp (PREVAIL II) ..................................................................................... 18 Deleted: 22 Rationale for Study ........................................................................................................... 18 2 STUDY OBJECTIVES ......................................................................................................... 20 Deleted: 22 Primary Objective ............................................................................................................. 20 Deleted: 22 Secondary Objectives ........................................................................................................ 20 Deleted: 22 Exploratory Objectives ..................................................................................................... 20 Deleted: 25 3 STUDY DESIGN.................................................................................................................. 20 Deleted: 25 General .............................................................................................................................. 20 Deleted: 25 Extension Phase ............................................................................................................ 23 Deleted: 25 Study Endpoints ................................................................................................................ 23 Primary Endpoint .......................................................................................................... 23 Deleted: 26 Secondary Endpoints .................................................................................................... 23 Deleted: 26 Exploratory Endpoints .................................................................................................. 24 Deleted: 26 Overview of Study Drugs ................................................................................................. 24 Deleted: 28 Considerations in Choice of Study Drugs ......................................................................... 24 Deleted: 28 Definitions for the Purpose of this Study .......................................................................... 26 Deleted: 28 4 STUDY POPULATION ....................................................................................................... 26 Deleted: 29 Research Subject Recruitment .......................................................................................... 26 Participation of Site Employees .................................................................................... 27 Deleted: 29 Inclusion Criteria .............................................................................................................. 27 Deleted: 29 Exclusion Criteria ............................................................................................................. 27 Deleted: 29 Vulnerable Populations ..................................................................................................... 27 Deleted: 29 Pregnant Women ........................................................................................................... 27 Deleted: 30 Inclusion of Children and Neonates .............................................................................. 28 Deleted: 30 Adults Who Are Unable to Provide Initial or Ongoing Consent .................................. 28 Subject Withdrawal ........................................................................................................... 28 Deleted: 30 Discontinuation of Subject by Investigator ....................................................................... 28 Deleted: 30 Discontinuation of Study .................................................................................................. 29 Deleted: 31 5 STUDY PROCEDURES ...................................................................................................... 29 Deleted: 31 Personnel for Study Procedures ........................................................................................ 29 Deleted: 31 Site-Specific Considerations ............................................................................................. 29 Deleted: 31 Schedule of Evaluations (see also Table 2 below) ............................................................ 30 Deleted: 32 Screening and Informed Consent ...................................................................................... 33 Demographics ............................................................................................................... 33 Deleted: 35 Deleted: 35 Deleted: 35 Deleted: 35 2018 Ebola MCM RCT Protocol Page 4 of 92 Deleted: 35 IND#: 125530 CONFIDENTIAL 4 October 2019, version 7.0 Deleted: 35 Medical History ............................................................................................................ 33 Deleted: 35 Clinical Data ................................................................................................................. 33 Deleted: 36 Determination of Eligibility .......................................................................................... 33 Deleted: 37 Day 1 ................................................................................................................................. 33 Deleted: 37 Baseline Evaluation ...................................................................................................... 33 Baseline Laboratory Testing ......................................................................................... 34 Deleted: 37 Randomization .............................................................................................................. 35 Deleted: 37 Study Drug Administration and Pharmacokinetic Sampling ............................................ 35 Deleted: 37 Pharmacokinetic Sampling ........................................................................................... 35 Deleted: 38 Follow-Up Study Days ....................................................................................................
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