COVID-19 trials registries data warehouse

http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=47179

Dr Dharampal Singh Sudan

hod.tbchest@sgtuniversity.org

2020-09-09

Recruiting

RCT

Randomized

Parallel

Open label

single-center

Prevention

1.Health care workers including doctors, nursing staff, para â?? medical staff and sanitation workers who shall be going for the COVID-19 isolation ward duty. <br/ >2.Female healthcare workers who are currently using reliable methods of contraception (barrier methods and intrauterine contraceptive device), with a negative urine pregnancy test during screening and agree to informed compliance of contraceptive method until at least 3 months post-revaccination with BCG. <br/ >3.The participants must be able and willing to comply with the study protocol, available and willing to complete all the study assessments and must have signed an Informed Consent Form <br/ >

1.Pregnant and / or lactating female healthcare workers. <br/ >2.A family history of congenital or hereditary immunodeficiency. <br/ >3.History of dialysis, silicosis, solid organ transplantation such as renal or cardiac transplants, and disorders of the heart, or nervous system, or other metabolic inflammatory conditions, psychiatric, occupational problems that make it unlikely that the patients will comply with the protocol as determined by the investigator. <br/ >4.History of administration of any immunoglobulins, any immunotherapy (antineoplastic chemotherapy, radiation therapy, immunosuppressants to induce tolerance to transplants, and corticosteroids use) and/or any blood products within the 3 months preceding study.. <br/ >5.Presence of any severe systemic/autoimmune disorders as determined by medical history and/or physical examination at the time of screening, which in the judgment of the Investigator would compromise the patientâ??s health or is likely to result in nonconformance to the protocol or a patientâ??s ability to give written informed consent. <br/ > <br/ >

2

SGT University

18

50

India

Health workers

N/A

400

1.Rate of infection of COVID-19 in healthcare workers re- <br/ >vaccinated with BCG as compared to controls <br/ >2.Change in the CD4+ T- cell count and CD8+T- <br/ >cell count â?? before vaccination and after 6 weeks. <br/ >3.Severity of COVID-19 infection in Healthcare workers revaccinated with BCG as compared to controls. <br/ > <br/ >Timepoint: At 6 weeks

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

Not reported

[{"arm_notes": "1 (revaccination)", "treatment_id": 186, "treatment_name": "Bcg vaccine", "treatment_type": "Non covid vaccine", "pharmacological_treatment": "Non covid vaccine"}, {"arm_notes": "1 (vaccination)", "treatment_id": 186, "treatment_name": "Bcg vaccine", "treatment_type": "Non covid vaccine", "pharmacological_treatment": "Non covid vaccine"}]