DOI: 10.17026/ls/bxdfs9
title: Reproducibility Data for NL trial in ALL-IN-META-BCG-CORONA
title: Individual participant data with calendar dates for use in a prospective living ALL-IN meta-analysis on two co-primary outcomes of COVID-19 infections and hospitalisations by randomized intervention BCG or control
title: Reproducibility Data for NL trial in ALL-IN-META-BCG-CORONA: Bacillus Calmette-Guérin vaccine to reduce COVID-19 infections and hospitalisations in healthcare workers – a living systematic review and prospective ALL-IN meta-analysis of individual participant data from randomised controlled trials

description: Dataset that was shared for the project ALL-IN-META-BCG-CORONA: a worldwide collaboration that started early 2020 to continuously update a prospective living meta-analysis based on interim data as well as final data from participating randomised controlled trials. &lt;br&gt; &lt;br&gt;

The goal was to determine as soon as possible the impact of the Bacillus Calmette-Guérin (BCG) vaccine compared to placebo or no vaccine on COVID-19 infections and hospitalisations in healthcare workers. The analysis tracks the evidence by calendar date and therefore needs individual participant data (IPD) with calendar dates that are considered personal/privacy-sensitive data. This is why the ALL-IN-META-BCG-CORONA reproducibility datasets cannot be openly shared despite the very limited information on participant characteristics. See the Terms and Files for restricted access. &lt;br&gt; &lt;br&gt;

This final NL trial data was last updated/shared on 6 November 2022 and contains data from 1496 healthcare workers included in the randomised controlled trial (ClinicalTrials.gov: NCT04328441) in the Netherlands between 25 March 2020 and 27 March 2021, with 8 columns specifying for each participant in a row: &lt;br&gt; &lt;br&gt;

&lt;b&gt;intervention&lt;/b&gt;: the arm the participant was randomised to (control or BCG); &lt;br&gt;
&lt;b&gt;dateRand&lt;/b&gt;: the calendar date of randomisation; &lt;br&gt;
&lt;b&gt;hospital&lt;/b&gt;: the hospital of randomisation (specifying a stratum in case of stratified randomisation); &lt;br&gt;
&lt;b&gt;COV19&lt;/b&gt;: whether the participant tested positive for COVID-19 infection (yes/no); &lt;br&gt;
&lt;b&gt;dateCOV19&lt;/b&gt;: calendar date of COVID-19 infection (or NA); &lt;br&gt;
&lt;b&gt;COV19hosp&lt;/b&gt;: whether the participant was hospitalised for COVID-19 (yes/no); &lt;br&gt;
&lt;b&gt;dateCOV19hosp&lt;/b&gt;: calendar date of COVID-19 hospitalisation (or NA); &lt;br&gt;
&lt;b&gt;dateLastFup&lt;/b&gt;: calendar date of last follow-up (indicating date of right-censoring when other dates are missing (NA)). &lt;br&gt; &lt;br&gt;

&lt;i&gt;Nota Bene: &lt;/i&gt;This data can only be used to reproduce the two co-primary analyses in ALL-IN-META-BCG-CORONA. Unlike IPD (Individual Participant Data) usually shared for meta-analysis, this dataset cannot answer other questions (e.g. subgroup analyses), because no further participant characteristics or other outcome measures are included. &lt;br&gt; &lt;br&gt;

For a full description of the data and all other available material to reproduce the analysis or start a similar (replication) project, see the MedRxiv preprint publication, the ResearchEquals replication package, and the full Dataverse data publication; all linked in the Relation Metadata.