Protective effect of re-vaccination withBCG against COVID-19 in healthcare workers â?? A Pilot Study

Not Applicable

• Registration Number: CTRI/2020/09/027684
• Lead Sponsor: SGT University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

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.

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.

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

Exclusion Criteria

1.Pregnant and / or lactating female healthcare workers.

2.A family history of congenital or hereditary immunodeficiency.

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.

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..

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified