COVID-19 trials registries data warehouse

http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=44078

Srikanth Tripathy

pcorchids@gmail.com

2020-06-13

Not recruiting

nonRCT

Non-randomized

Parallel

Not reported

multi-center

Prevention

1)Elderly individuals 60 years â?? 95 years of age with general good health, as confirmed by history and physical examination. <br/ > <br/ >2) No known history of HIV or on immunosuppressive drugs for malignancy or transplant <br/ > <br/ >3) Provide a signed and dated informed consent form <br/ > <br/ >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.

1) Positive for SARS-Cov2 infection, by either antibody (serology) or PCR test <br/ >2) Known HIV or malignancy or Transplant recipient or on Dialysis <br/ >3) Individuals on immune-suppressive therapies or treatments for malignancy or transplant / dialysis / anti-retroviral treatment <br/ >4) Recently (in the last 6-months) diagnosed with TB or currently on anti-TB treatment or anti-psychiatric medications <br/ >5) Has any BCG vaccine contraindication like allergy or hypersensitivity to BCG, individuals with HIV infection, leukaemia, malignant lymphoma, chronic granulomatous disease, <br/ >6) H/o of previous administration of experimental MTB vaccines within the past 6 months. <br/ >7) Sick and moribund individuals with Karnofsky score <50 <br/ >

2

Indian Council of Medical Research

60

95

India

High risk patients

N/A

1450

Proportion of patients with Severe COVID disease based on COVID Severity Scale and proportion of death due to Covid 19 disease <br/ >Timepoint: 6 months post vaccination

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

Not reported

[{"arm_notes": "1", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}, {"arm_notes": "1", "treatment_id": 186, "treatment_name": "Bcg vaccine", "treatment_type": "Non covid vaccine", "pharmacological_treatment": "Non covid vaccine"}]