CTRI Number	CTRI/2020/09/027684 [Registered on: 09/09/2020] Trial Registered Prospectively
Last Modified On:	29/09/2020
Post Graduate Thesis	No
Type of Trial	Interventional
Type of Study	Vaccine Preventive
Study Design	Randomized, Parallel Group Trial
Public Title of Study	Protective effect of re-vaccination with BCG against COVID-19 in healthcare workers – A Pilot Study
Scientific Title of Study	Protective effect of re-vaccination with BCG against COVID-19 in healthcare workers – A Pilot Study
Secondary IDs if Any	Secondary ID  Registry  NIL  NIL
Details of Principal Investigator or overall Trial Coordinator (multi-center study) Modification(s)	Name  Dr Dharampal Singh Sudan  Address  Department Of Pulmonary Medicine SGT Hospital, Medical College and research Institute SGT University Budhera Gurugram Gurgaon HARYANA 122505 India  Phone  9888603012   Fax     Email  hod.tbchest@sgtuniversity.org
Details Contact Person Scientific Query Modification(s)	Name  Dr Dharampal Singh Sudan  Address  Department Of Pulmonary Medicine SGT Hospital Medical College and Research Institute SGT University Budhera Gurugram Gurgaon HARYANA 122505 India  Phone  9888603012   Fax     Email  hod.tbchest@sgtuniversity.org
Details Contact Person Public Query Modification(s)	Name  Dr Dharampal Singh Sudan  Address  Department Of Pulmonary Medicine SGT Hospital Medical College and Research Institute SGT University Budhera Gurugram Gurgaon HARYANA 122505 India  Phone  9888603012   Fax     Email  hod.tbchest@sgtuniversity.org
Source of Monetary or Material Support Modification(s)	ICMR ( Seeking grant)  SGT University Budhera Gurugram
Primary Sponsor	Name  SGT University  Address  SGT University, Budhera, gurugram,Haryana  Type of Sponsor  Private medical college
Details of Secondary Sponsor	Name  Address  NIL  NIL
Countries of Recruitment	India
Sites of Study Modification(s)	No of Sites = 1   Contact Person  Name of Site  Site Address  Phone/Fax/Email  Dr Dharampal Singh Sudan  Department Of Pulmonary Medicine, SGT Hospital  SGT Hospital, A constituent of SGT University, Budhera Gurgaon   9888603012 hod.tbchest@sgtuniversity.org
Details of Ethics Committee Modification(s)	No of Ethics Committees= 1   Name of Committee  Approval Status  Institutional Ethics Committee , SGT Medical College Hospital  Approved
Regulatory Clearance Status from DCGI	Status  Not Applicable
Health Condition / Problems Studied	Health Type  Condition  Healthy Human Volunteers  Healthy individuals
Intervention / Comparator Agent Modification(s)	Type  Name  Details  Comparator Agent  BCG Re-vaccination  Rate of infection of COVID-19 in healthcare workers given BCG revaccination as compared to controls  Intervention  BCG Vaccine  0.1 ml reconstituted BCG vaccine administered intra-dermally single dose to be given one week prior to COVID-19 isolation ward duty
Inclusion Criteria	Age From  18.00 Year(s) Age To  50.00 Year(s) Gender  Both  Details  1.Health care workers including doctors, nursing staff, para – 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
ExclusionCriteria	Details  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 patient’s health or is likely to result in nonconformance to the protocol or a patient’s ability to give written informed consent.
Method of Generating Random Sequence	Random Number Table
Method of Concealment	An Open list of random numbers
Blinding/Masking	Open Label
Primary Outcome Modification(s)	Outcome  TimePoints  1.Rate of infection of COVID-19 in healthcare workers re- vaccinated with BCG as compared to controls 2.Change in the CD4+ T- cell count and CD8+T- cell count – before vaccination and after 6 weeks. 3.Severity of COVID-19 infection in Healthcare workers revaccinated with BCG as compared to controls.   At 6 weeks
Secondary Outcome	Outcome  TimePoints  1.Severity of COVID-19 infection in Healthcare workers revaccinated with BCG as compared to controls.   1.1 week after the COVID-19 isolation ward duty. 2. After 6 weeks 3. Follow-up after 1 month
Target Sample Size	Total Sample Size="400" Sample Size from India="400"
Phase of Trial	N/A
Date of First Enrollment (India)	15/09/2020
Date of First Enrollment (Global)	No Date Specified
Estimated Duration of Trial	Years="1" Months="0" Days="0"
Recruitment Status of Trial (Global) Modification(s)	Not Applicable
Recruitment Status of Trial (India)	Open to Recruitment
Publication Details Modification(s)	NIL
Brief Summary	SGT Hospital is a Haryana government designated partial COVID hospital with total COVID bed strength of 180 beds. A team of healthcare workers including 4 doctors, 12 nursing staff, 2 lab technicians , 4 sanitations workers are deployed every week. Till now, no team of healthcare workers have repeated the duty. Written and informed consent shall be obtained from the participants involved in the study. The study will include all healthcare workers including doctors, nursing staff, para-medical staff,sweepers and sanitisation workers.  The study would be randomized , non-blinded ,two arm study and shall be conducted over a period of 1 year in which enrollment of the participants would be done for 11 months from the time of approval of the study and 1 month of follow-up. Health care workers who would be going for COVID-19 ward duties during the period of study shall be randomly distributed in 2 groups i.e the control group and the test group. Prior to enrollment in the study , clinical screening of the healthcare worker would be done and the scar mark of previous BCG vaccine would be checked which is administered to every individual at birth as per National Immunization schedule, and the healthcare workers would be randomly distributed in the study groups. Baseline CD4+ T – cell count & CD8+ T-cell count would be recorded for the test group and after that, BCG vaccine would be administered 1 week prior to COVID-19 ward duty as per standard protocol. Method of Administration   BCG vaccine would be administered in a dose of 0.1mg in 0.1 ml volume which shall be injected intradermally using a “Tuberculin” syringe ( Omega microstat syringe fitted with a 1cm steel 26 gauge intradermal needle) just above the insertion of deltoid muscle on the left upper arm.  All health care workers receiving vaccine would be informed about the complications associated with vaccination such as ulceration at the site of vaccination ,suppurative lymphadenitis , local abcess formation etc.  There shall be 4 encounters with the participants as described below with the purpose of encounters :- Encounter-1 Encounter-2 Encounter-3 Encounter-4 Clinical screening of the healthcare worker   Enrollment in the applicable group   Scar mark of previous BCG vaccination   Estimation of baseline CD4+ T cell counts and CD8+ T cell counts. Administration of BCG vaccine 1 week prior to COVID-19 isolation ward duty.   Physical signs and vitals of the healthcare workers would be recorded. All healthcare workers would be quarantined for a period of 1 week after the COVID-19 isolation ward duty and their nose and oropharyngeal swab would be sent for RT-PCR on Day-7 of their quarantine.   All healthcare workers would be investigated about development of any new symptoms.   Physical signs and vitals of the healthcare workers would be recorded. Follow-up at 6 weeks for repeat estimation of CD4+ T cell counts and CD8+ T cell counts.   All healthcare workers would be investigated about development of any new symptoms.   Physical signs and vitals of the healthcare workers would be recorded.   For the estimation of CD4+ T Cell Count and CD8+ T cell count , blood samples would be analyzed by a commercial laboratory in the SGT campus , as they will bring the FACs scanner to our laboratory for the purpose of this study. Participants will be followed up after 1 month. All the participants who will be re-vaccinated with BCG Vaccine are healthy individuals. Hence, no clinical performa has been included.