None listed
Conditions
Interventions
Intervention1: BCG-Denmark (Green Signal): BCG-Denmark (Green Signal), 0.1 ml, intradermal injection in left deltoid area
Control Intervention1: Placebo: Normal saline, 0.1 ml administered intradermal
Sponsors
Dr Narayanan Parameswaran
Eligibility
Inclusion criteria
Inclusion criteria: 1. All HCWs (doctors and nurses and housekeeping staff) posted to take care of patients in the designated COVID 19 wards / ICUs for at least one shift (minimum 6 hours). 2. All HCWs (doctors and nurses and housekeeping staff) likely to be posted in Emergency medical services (EMS) for one week (minimum 56 hours). 3. All laboratory workers likely to be posted for at least one week in a Virology laboratory where SARS-CoV-2 testing is being performed.
Exclusion criteria
Exclusion criteria: 1.HCWs not directly involved in patient care (facility manager, supervisory staff not physically present in the patient care areas) 2. A immunodeficiency state (including primary immunodeficiency, HIV infection, chemotherapy or high-dose steroid therapy (more than or equal to 20 mg for more than or equal to 2 weeks),non-biological immunosuppressant (also known as DMARDS), biological agents (such as monoclonal antibodies against tumor necrosis factor (TNF)-alpha) 3. Pregnancy 4.Malignancy 5.Active skin disease such as eczema, dermatitis or psoriasis at or near the site of vaccination. 6.Previously had a SARS-CoV-2 positive test result 7.BCG vaccine received in the past one year
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of HCW with symptomatic COVID 19 disease 6 months after randomization. Symptomatic COVID 19 will be defined as self-reported fever or cough, or shortness of breath, or respiratory distress, or runny or blocked nose plus a positive PCR test and/or antibody testTimepoint: Six months after randomisation | — |
Secondary
| Measure | Time frame |
|---|---|
| Any adverse effects of intervention (BCG adenitis, disseminated BCG etc)Timepoint: Six months after randomisation;Mortality if any due to COVID 19 diseaseTimepoint: Six months after randomisation;Proportion of HCWs who develop any type of SARS-CoV-2 infection (both asymptomatic and symptomatic)Timepoint: Six months after randomisation;Proportion of HCWs with Pneumonia (mild and severe) and ARDS requiring hospitalization due to SARS-CoV-2Timepoint: Six months after randomisation | — |
Countries
India
Contacts
Public ContactNarayanan Parameswaran
JIPMER, Puducherry
Outcome results
None listed