Table 1

Study assessments and timing

DomainAssessmentTime pointRationale
QuestionnairesDemographicsD0To be used in multivariate analysis
Medical historyD0To be used in multivariate analysis
Household risk factorsD0To be used in multivariate analysis
MedicationsD0, D28, D60To be used in multivariate analysis
Exposure historyD0, D7, D14, D21, D28, D60To be used in multivariate analysis
Symptoms/adverse eventsD0, D7, D14, D21, D28, D60Monitor safety
COVID-19-related event reportingD7, D14, D21, D28, D60To be used in multivariate analysis
Adherence to treatmentD7, D14, D21, D28To be used in multivariate analysis
Study arm (patients’ self-assessment of to which arm they were randomised)D28To be used in multivariate analysis
MicrobiotaStool collection (OMNIgene-GUT kit)D0, D7, D28Gut microbiota analysis
Nasal swab collectionD0, D7, D28COVID-19 infection status