Reproducibility Data for SA trial in ALL-IN-META-BCG-CORONA

<p>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.</p>

<p>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 was set up for 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.</p>

<p>This final SA trial data was last updated/shared on 2 December 2022 and contains data from 1000 healthcare workers included in the randomised controlled trial (ClinicalTrials.gov: NCT04379336) in South Africa between 4 May 2020 and 18 October 2021, with 8 columns specifying for each participant in a row:</p>

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

<p><i>Nota Bene: </i>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.</p>

<p>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 and the ResearchEquals replication package; both linked in the Relation Metadata.</p>