Data collected from the questionnaires
| Participant questionnaires | Eligibility check | Baseline / randomisation | Vaccine diary* | 3-mly FU† | Episode FU |
| Demographics, medical history | |||||
| Inclusion and exclusion criteria | X | ||||
| Age, sex, BMI, comorbidities (diabetes, cardiovascular disease, chronic respiratory disease, hypertension), alcohol, smoking | X | ||||
| Medication: use of hydroxychloroquine, azithromycin, lopinavir-ritonavir, oseltamivir or antihypertensive drugs | X | X | |||
| Vaccination: timing of administration of other vaccine(s) | X | ||||
| Mycobacterium spp exposure: prior BCG vaccination, previous positive TST, latent TB, or stay in high TB prevalence country | X | X | |||
| Cold sores recurrences and impact on quality of life | X | X | |||
| COVID-19 exposure | |||||
| Workplace: profession, department, amount of direct patient contact, contact with COVID-19 cases | X | X | |||
| Household: composition, COVID-19 exposure | X | X | |||
| BCG vaccination site | |||||
| Photograph of BCG vaccination site | X | X | X | ||
| Vaccine site reaction (pain, redness, swelling, tenderness) | X | ||||
| Enlarged lymph node | X | ||||
| BCG scarring and complication | X | X | |||
| Illness episode | |||||
| Presence of fever, cough, shortness of breath/difficulty breathing, sore throat, runny/blocked nose, fatigue, muscle or joint pain, headache, nausea or vomiting, diarrhoea, loss of smell or taste | X | X | |||
| COVID-19 test result | X | X | |||
| Days absent from work | X | X | |||
| Days confined to bed | X | ||||
| Medical consultation, ED presentation | X | X | |||
| Hospital admission | X | X | |||
| Complications | X | X |
*Completed during the 2 weeks following vaccination.
†Questionnaire available in the online supplemental material.
BMI, body mass index; ED, emergency department; Episode, illness episode; FU, follow-up; mly, monthly; TB, tuberculosis; TST, tuberculin skin test.