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.

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.

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:

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

Nota Bene: 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.

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.