Clinical Trial Title: PROTECT-CH Full title: COVID-19: PROphylactic ThErapy in Care homes Trial-CH Philip M Bath University of Nottingham - Chief Investigator Adam Gordon University of Nottingham - Deputy Investigator EudraCT number (CTIMPs only) 2021-000185-15 Sponsor reference number 21001 IRAS Project ID 294832 Research Question In residents in a UK care home setting (P), which drug or antibody interventions (I) when compared to standard care (C) are effective, safe and cost-effective (O) as prophylaxis for COVID-19? Primary objective To provide reliable estimates of the effect of trial treatments for each pairwise comparison with the standard care arm on SARS-CoV-2 infection, morbidity and mortality 60 days after randomisation (or appropriate point dependent on the intervention – where this differs to 60 days further detail will be provided in the specific investigational medicinal product (IMP) Appendix). Secondary objectives To assess the effects of trial treatments on mortality (all-cause and cause-specific), admission to hospital (all-cause and cause-specific), healthcare referrals for COVID-19, infection (asymptomatic, symptomatic), time to symptomatic infection and safety through serious adverse reactions. To assess the effects of trial treatments on transmission of SARS-CoV-2 infection. Tertiary objectives To assess the cost-effectiveness of trial treatments and explain the contextual factors which influence trial processes including adherence to intervention and outcome measurement regimens, and which might impact on subsequent implementations of pre- or post-exposure prophylaxis for COVID-19 in care homes. This project was funded by the National Institute for Health Research (NIHR) HTA Programme (project reference NIHR133443). Backstory ========= The trial was to be run by the Nottingham Clinical Trials Unit, but was closed down before the first patient was recruited due to the effectiveness of the UK vaccine program in preventing serious disease. This meant the trial as planned no longer had the statistical power to answer the questions. Most, but not all UAT had been completed by the time the decision was taken to halt the project. The PROCTECT-CH systems contained several subsystems, and not all of them are published here due to reasons of IP. What is published will therefore not work in isolation, but may contain interesting or useful ideas for other similar future projects in a care home setting that use REDCap. Unpublished REDCap modules may be published in future, but at the time of writing are not available outside of the UKCRC registered trials units. Intervention drug names have also been redacted from the REDCap XML files. System/Document Published README Yes (This file) PROTECT Site Survey Yes (REDCap project XML) PROTECT-CH Yes (REDCap project XML) PROTECT-CH Centres Yes (REDCap project XML) PROTECT-CH VAULT No (Not published for security reasons) Aberdeen CHaRT Management system No (Not published here, as not the IP of the University of Nottingham) System Data Context Diagram Yes (pdf) REDCap External Modules used: Advanced Reports – v1.2.2 No API Client – v1.0.2 No Extra Calculation Functions – v1.0.0 No Form Render Skip Logic – v3.3.13 Yes (by Philip Chase (University of Florida - CTSI), Taryn Stoffs (University of Florida - CTSI), Kyle Chesney (University of Florida - CTSI)) Minimization – v1.1.1 No REDCap JavaScript Injector – v1.1.3 Yes (by Günther Rezniczek (Ruhr-Universität Bochum)) REDCap UI Tweaker – v1.2.1 No Show by roles – v1.5 Yes (by Lieven Vaneeckhaute (University Hospital Ghent)) Validation Tweaker – v1.0.2 No