COVID-19 trials registries data warehouse

http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=43105

Narayanan Parameswaran

narayanan.p@jipmer.edu.in

2020-04-24

Not recruiting

RCT

Randomized

Parallel

Blind label

multi-center

Prevention

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). <br/ >2. All HCWs (doctors and nurses and housekeeping staff) likely to be posted in Emergency medical services (EMS) for one week (minimum 56 hours). <br/ >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. <br/ >

1.HCWs not directly involved in patient care (facility manager, supervisory staff not physically present in the patient care areas) <br/ >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) <br/ >3. Pregnancy <br/ >4.Malignancy <br/ >5.Active skin disease such as eczema, dermatitis or psoriasis at or near the site of vaccination. <br/ >6.Previously had a SARS-CoV-2 positive test result <br/ >7.BCG vaccine received in the past one year <br/ >

2

Dr Narayanan Parameswaran

18

65

India

Health workers

N/A

1826

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

| Declared number of arm (2.0) differs from found arms (3.0)

Not reported

[{"arm_notes": "1", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}, {"arm_notes": "1", "treatment_id": 186, "treatment_name": "Bcg vaccine", "treatment_type": "Non covid vaccine", "pharmacological_treatment": "Non covid vaccine"}]