Convalescent Plasma in Critically Ill Patients with Covid-19
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Convalescent Plasma in Critically Ill Patients with Covid-19 The REMAP-CAP Investigators Supplementary Appendix Table of Contents Convalescent Plasma in Critically Ill Patients with Covid-19 ..................................................................... 1 1. REMAP-CAP investigators and collaborators .................................................................................... 3 REMAP-CAP Trial Investigators & Collaborators ................................................................................................ 3 International Trial Steering Committee:.................................................................................................................................... 3 Regional Management Committees .......................................................................................................................................... 3 Regional Coordinating Centers .................................................................................................................................................. 4 Domain-Specific Working Groups ............................................................................................................................................. 4 Statistical Analysis Committee .................................................................................................................................................. 7 Statistical Design Team.............................................................................................................................................................. 7 Project Management ................................................................................................................................................................. 7 Data and Safety Monitoring Board ............................................................................................................................................ 8 Database Providers.................................................................................................................................................................... 8 Site Investigators and Research Coordinators........................................................................................................................... 8 Clinical Trials Groups ............................................................................................................................................................... 30 Blood Transfusion Services ............................................................................................................................. 31 Australia .................................................................................................................................................................................. 31 Canada ..................................................................................................................................................................................... 31 New Zealand ............................................................................................................................................................................ 33 United Kingdom ....................................................................................................................................................................... 33 United States Blood Transfusion Services ............................................................................................................................... 35 Sample reception, processing, storage and testing laboratories....................................................................... 35 Australia .................................................................................................................................................................................. 35 Canada ..................................................................................................................................................................................... 36 United Kingdom ....................................................................................................................................................................... 36 2. Supplementary methods ............................................................................................................... 38 Patient eligibility criteria ................................................................................................................................ 38 Platform eligibility (Pandemic appendix to the core protocol) ............................................................................................... 38 Immunoglobulin Domain eligibility ......................................................................................................................................... 38 Definition of Moderate and Severe States ...................................................................................................... 39 Definition of Immunodeficiency ..................................................................................................................... 39 Definition of per protocol ............................................................................................................................... 40 Collection and distribution of convalescent plasma ......................................................................................... 40 Australia .................................................................................................................................................................................. 40 Canada ..................................................................................................................................................................................... 41 United Kingdom ....................................................................................................................................................................... 41 United States ........................................................................................................................................................................... 42 Measurement of participant baseline SARS-CoV-2 serostatus .......................................................................... 43 Australia .................................................................................................................................................................................. 43 United Kingdom ....................................................................................................................................................................... 43 United States ........................................................................................................................................................................... 44 Measurement of participant baseline SARS-CoV-2 PCR status ......................................................................... 44 United Kingdom ....................................................................................................................................................................... 44 Treatment allocation and interventions .......................................................................................................... 44 Available Interventions............................................................................................................................................................ 44 Convalescent plasma at randomization .................................................................................................................................. 44 No immunoglobulin to SARS-CoV-2 (control) .......................................................................................................................... 45 Delayed convalescent plasma ................................................................................................................................................. 45 Secondary outcomes ...................................................................................................................................... 45 REMAP-CAP Core Protocol Secondary Outcomes: .................................................................................................................. 45 Immunoglobulin Domain Secondary Outcomes...................................................................................................................... 46 Secondary Outcomes prespecified in Statistical Analysis Plan ................................................................................................ 46 3. Supplementary figures .................................................................................................................. 47 Figure S1 ........................................................................................................................................................ 47 Figure S2 ........................................................................................................................................................ 48 4. Supplementary Tables ................................................................................................................... 49 Table S1. Participant Characteristics at Baseline* ............................................................................................ 49 Table S2. Randomisation into