BCG-Denmark versus no-BCG for COVID 19 preventio

Not Applicable

Registration Number: CTRI/2020/04/024833

Lead Sponsor: Dr Narayanan Parameswaran

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

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

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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