Status:
COMPLETED
BCG Vaccine in Reducing Morbidity and Mortality in Elderly Individuals in COVID-19 Hotspots
Lead Sponsor:
Tuberculosis Research Centre, India
Collaborating Sponsors:
ICMR-National Institute for Research in Tuberculosis, Chennai, Tamil Nadu
All India Institute of Medical Sciences
Conditions:
COVID
Eligibility:
All Genders
60-80 years
Phase:
PHASE3
Brief Summary
Rationale: SARS-CoV2 viral infection is spreading rapidly throughout the world and in India the epidemic poses a major threat to the public health system. Elderly individuals, especially those with di...
Detailed Description
Recruitment area: Under the Lockdown 2.0, the country has been classified into three key zones-Red, Orange and Green (26). These zones will support the cluster containment plan announced by the govern...
Eligibility Criteria
Inclusion
- Adults 60 years of age or older (\<100 years) with general good health, as confirmed by history and physical examination.
- No known history of HIV or on immunosuppressive drugs for malignancy or transplant
- Provide a signed and dated informed consent form
Exclusion
- Positive for SARS-Cov2 infection
- Known HIV or other immune-suppressive treatments for malignancy or transplant
- Recently diagnosed as TB or currently on anti-TB treatment or anti-psychiatric medications
- Has any BCG vaccine contraindication
- H/o of previous administration of experimental MTB vaccines within the past 6 months.
- Sick and moribund individuals with Karnofsky score \<50
- Elderly individuals with or without co-morbid conditions like Diabetes mellitus, or Hypertension or Hyperlipidemia will be considered for this study, if they are on regular treatment.
Key Trial Info
Start Date :
July 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 20 2021
Estimated Enrollment :
2175 Patients enrolled
Trial Details
Trial ID
NCT04475302
Start Date
July 1 2020
End Date
September 20 2021
Last Update
July 8 2022
Active Locations (1)
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1
Tuberculosis Research Centre
Chennai, Tamil Nadu, India, 600031