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CTRI Trial Data PDF of Trial CTRI Website URL - http://ctri.nic.in Clinical Trial Details (PDF Generation Date :- Fri, 24 Sep 2021 12:05:12 GMT) CTRI Number CTRI/2020/05/025013 [Registered on: 05/05/2020] - Trial Registered Prospectively Last Modified On 04/05/2020 Post Graduate Thesis No Type of Trial Interventional Type of Study Vaccine Study Design Non-randomized, Active Controlled Trial Public Title of Study Evaluation of BCG as potential therapy for COVID-19 Scientific Title of Phase 2 Clinical Trial for the Evaluation of BCG as potential therapy for CoVID-I9 Study Secondary IDs if Any Secondary ID Identifier BIO/CT/20/000049 DCGI NIL NIL Details of Principal Details of Principal Investigator Investigator or overall Name Dr Rajesh Deshmukh Trial Coordinator (multi-center study) Designation Director, Haffkine Institute Affiliation Haffkine Institute for Training Research and Testing Address Haffkine Institute for Training Research and Testing Acharya Donde Marg Parel, Mumbai 400012 Haffkine Institute for Training Research and Testing Acharya Donde Marg Parel, Mumbai 400012 Mumbai MAHARASHTRA 400012 India Phone 02224160947 Fax 02224161787 Email [email protected] Details Contact Details Contact Person (Scientific Query) Person (Scientific Name Dr Usha Padmanabhan Query) Designation Sr. Sci. Officer Haffkine Institute Affiliation Haffkine Institute for Training, Research & Testing Address Biochemistry Department, Haffkine Institute for Training Research and Testing Acharya Donde Marg Parel, Mumbai 400012 Tel 022-24160947 ext 220, 232 Fax 022-24161787 Same as address 1 Mumbai MAHARASHTRA 400012 India Phone 02224160947 Fax 02224161787 Email [email protected] Details Contact Details Contact Person (Public Query) Person (Public Query) Name Dr Sanjay Mukherjee Designation Hon. Principal Secretary Affiliation Medical Education and Drugs Department Address 9th floor, Mantralay, GT Hospital Campus, Fort, Mumbai 9th floor, Mantralay, GT Hospital Campus, Fort, Mumbai Mumbai MAHARASHTRA page 1 / 8 PDF of Trial CTRI Website URL - http://ctri.nic.in 400001 India Phone 022-22622179 Fax Email [email protected] Source of Monetary or Source of Monetary or Material Support Material Support > Medical Education and Drugs Department 9th floor, Mantralay, GT Hospital Campus, Fort, Mumbai 400001 Primary Sponsor Primary Sponsor Details Name Medical Education and Drugs Department Address 9th floor, Mantralay, GT Hospital Campus, Fort, Mumbai 400001 Type of Sponsor Government funding agency Details of Secondary Name Address Sponsor Haffkine Institute for Training Research Testing Acharya Donde Marg, Parel, Mumbai 400 012 Countries of List of Countries Recruitment India Sites of Study Name of Principal Name of Site Site Address Phone/Fax/Email Investigator Dr Sonali Salvi Sassoon General Jai Prakash Narayan 02026126010 Hospital Road, Near Pune 02026126868 Railway Station, Pune - [email protected] 411001 Pune MAHARASHTRA Details of Ethics Name of Committee Approval Status Date of Approval Is Independent Ethics Committee Committee? BJ Medical College and Approved 02/05/2020 No SGH Regulatory Clearance Status Date Status from DCGI Approved/Obtained 01/05/2020 Health Condition / Health Type Condition Problems Studied Patients Coronavirus as the cause of diseases classified elsewhere Patients Respiratory conditions due to unspecified external agent Intervention / Type Name Details Comparator Agent Intervention BCG plus STANDARD of CARE DOSE 0.1 ml ROUTE OF as suggested by DCGI ADMINISTRATION Intradermal FREQUENCY Only once during the entire trial DURATION 1-2 min time required to inject subject. It is not continuous therapy. Comparator Agent SALINE plus STANDARD of DOSE 0.1 ml ROUTE OF CARE as suggested by DCGI ADMINISTRATION Intradermal FREQUENCY Only once during the entire trial DURATION 1-2 min time required to inject subject. It is not continuous therapy. Inclusion Criteria Inclusion Criteria page 2 / 8 PDF of Trial CTRI Website URL - http://ctri.nic.in Age From 20.00 Year(s) Age To 40.00 Year(s) Gender Both Details Hospitalized subjects either male or female with confirmed COVID-19 will be included in this as per following criteria:<br/> 1. Age 20 - 50 years<br/> 2. Symptomatic subjects with fever (using self-reported questionnaire) plus at least one sign or symptom of respiratory disease including cough, shortness of breath, respiratory distress/failure, runny/blocked nose (using self-reported questionnaire), plus<br/> 3. Positive SARS-Cov-2 test in nasopharyngeal sample at admission (using RT-PCR as prescribed by WHO, ICMR and NCDC) Exclusion Criteria Exclusion Criteria Details Subjects outside the age group Subjects who test negative for nCOV-19 by RT-PCR as per criteria laid down by ICMR. Subjects with 1. Any co-morbidities such as renal distress, cardiac malfunction etc. at time of admission 2. Any disorder in which natural immune response is altered, 3. Systemic lupus 4. Hypogamma-globulinemia, 5. Congenital immunodeficiency, 6. Sarcoidosis, 7. Leukaemia, 8. Generalised malignancy, 9. HIV infections or as also those on immunosuppressive therapy, corticosteroids, radiotherapy. 10. Inchronic eczema or other dermatological disease 11. Pregnant women, lactating (breast-feeding) women Method of Generating Other Random Sequence Method of On-site computer system Concealment Blinding/Masking Participant Blinded Primary Outcome Outcome Timepoints Primary Outcome Measures: Primary Outcome Measures: 1.Total duration of Hospitalization with 1.Total duration of Hospitalization with COVID-19 symptoms such as febrile respiratory COVID-19 symptoms such as febrile respiratory distress [Time Frame: from admission until distress [Time Frame: from admission until discharge] discharge] 2.Decrease in Viral Titer [Time Frame: Measured 2.Decrease in Viral Titer [Time Frame: Measured on day of enrolment, on day 7 and 15 after on day of enrolment, on day 7 and 15 after intervention] intervention] 3.Duration of COVID-19 symptoms [Time Frame: 3.Duration of COVID-19 symptoms [Time Frame: At time of admission, following enrollment until At time of admission, following enrollment until discharge] discharge] Secondary Outcome Outcome Timepoints 1.Local and systemic adverse events to BCG 1.Local and systemic adverse events to BCG vaccination. [Time Enrolment to 3 months] vaccination. [Time Enrolment to 3 months] 2.No. of ICU admissions [Time Enrolment to 3 2.No. of ICU admissions [Time Enrolment to 3 months] months] 3.Duration of ICU admission [Time Enrolment to 3.Duration of ICU admission [Time Enrolment to 3 months] 3 months] 4.Number of participants needing mechanical 4.Number of participants needing mechanical ventilation [Time Enrolment to 3 months] ventilation [Time Enrolment to 3 months] 5.Duration of Mechanical ventilation [Time 5.Duration of Mechanical ventilation [Time page 3 / 8 PDF of Trial CTRI Website URL - http://ctri.nic.in Enrolment to 3 months] Enrolment to 3 months] 6.Mortality [Time From enrolment] 6.Mortality [Time From enrolment] 7.Time for resolution of COVID-19 disease [Time 7.Time for resolution of COVID-19 disease [Time From enrollment] From enrollment] 8.Hospitalization cost [Time From enrollment] 8.Hospitalization cost [Time From enrollment] 1. Change in IgG and IgM induced by nCoV-19 1. Change in IgG and IgM induced by nCoV-19 in serum [Time Day 0 and days 7 and 15 after in serum [Time Day 0 and days 7 and 15 after BCG intervention] BCG intervention] 2. Change in total IgG and IgM levels in serum 2. Change in total IgG and IgM levels in serum [Time Day 0 and days 7 and 15 after BCG [Time Day 0 and days 7 and 15 after BCG intervention] intervention] 3. Change in Th1 and Th2 cytokines as 3. Change in Th1 and Th2 cytokines as assessed by RT-PCR using RNA extracted from assessed by RT-PCR using RNA extracted from hematocrit [Time Day 0 and days 7 and 15 after hematocrit [Time Day 0 and days 7 and 15 after BCG intervention] BCG intervention] Target Sample Size Total Sample Size=60 Sample Size from India=60 Final Enrollment numbers achieved (Total)=Applicable only for Completed/Terminated trials Final Enrollment numbers achieved (India)=Applicable only for Completed/Terminated trials Phase of Trial Phase 2 Date of First 06/05/2020 Enrollment (India) Date of First No Date Specified Enrollment (Global) Estimated Duration of Years=0 Trial Months=3 Days=0 Recruitment Status of Not Applicable Trial (Global) Recruitment Status of Not Yet Recruiting Trial (India) Publication Details none Brief Summary Evaluation of BCG as potential therapy for COVID-19 Summary Background and Introduction The novel coronavirus nCoV-19 (or SARS-CoV-2 or 2019-nCoV), responsible for the global pandemic COVID-19 was isolated from human airway epithelial cells from patients from Wuhan, China in December 2019 (Wang et al, 2020; Zhu et al, 2020). Seven coronaviruses (CoVs) have been described so far infecting humans of which the SARS-CoV (Kuiken et al, 2003), MERS-CoV and nCoV-19 are serious threats to humans. No therapies or vaccines have been approved for SARS or MERS thus far, demonstrating the need to develop effective therapies or vaccines. BacilleCalmette-Guérin, BCG is a vaccine against tuberculosis that is prepared from a strain of the attenuated (weakened) live bovine tuberculosis bacillus, Mycobacterium page 4 / 8 PDF of Trial CTRI Website URL - http://ctri.nic.in bovis. The bacilli have retained enough strong antigenicity to become an 80% effective vaccine for the prevention of human tuberculosis. Overall, BCG vaccine reduces the risk of
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