Evaluation of BCG as potential therapy for COVID-19

Phase 2 Clinical Trial for the Evaluation of BCG as potential therapy for CoVID-I9 - COVID-19 BCG

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2020/05/025013

Enrollment

Registered

2020-05-05

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere Health Condition 2: J709- Respiratory conditions due to unspecified external agent

Interventions

Intervention1: BCG (Brand Name Tubervac, Serum Institute of India) Tamiflu Hydroxychloroquine Azithromycin: DOSAGE: 0.1 ml BCG should be administered once during the entire period of the trial ROUTE

Eligibility

Inclusion criteria

Inclusion criteria: Hospitalized subjects either male or female with confirmed COVID-19 will be included in this as per following criteria: 1. Age 20 - 50 years 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 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: 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

Design outcomes

Primary

Measure	Time frame
Primary Outcome Measures: 1.Total duration of Hospitalization with COVID-19 symptoms such as febrile respiratory distress [Time Frame: from admission until discharge] 2.Decrease in Viral Titer [Time Frame: Measured on day of enrolment, on day 7 and 15 after intervention] 3.Duration of COVID-19 symptoms [Time Frame: At time of admission, following enrollment until discharge]Timepoint: Primary Outcome Measures: 1.Total duration of Hospitalization with COVID-19 symptoms such as febrile respiratory distress [Time Frame: from admission until discharge] 2.Decrease in Viral Titer [Time Frame: Measured on day of enrolment, on day 7 and 15 after intervention] 3.Duration of COVID-19 symptoms [Time Frame: At time of admission, following enrollment until discharge]	—

Measure

Time frame

Primary Outcome Measures: 1.Total duration of Hospitalization with COVID-19 symptoms such as febrile respiratory distress [Time Frame: from admission until discharge] 2.Decrease in Viral Titer [Time Frame: Measured on day of enrolment, on day 7 and 15 after intervention] 3.Duration of COVID-19 symptoms [Time Frame: At time of admission, following enrollment until discharge]Timepoint: Primary Outcome Measures: 1.Total duration of Hospitalization with COVID-19 symptoms such as febrile respiratory distress [Time Frame: from admission until discharge] 2.Decrease in Viral Titer [Time Frame: Measured on day of enrolment, on day 7 and 15 after intervention] 3.Duration of COVID-19 symptoms [Time Frame: At time of admission, following enrollment until discharge]

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Secondary

Measure	Time frame
1. Change in IgG and IgM induced by nCoV-19 in serum [Time Day 0 and days 7 and 15 after BCG intervention] 2. Change in total IgG and IgM levels in serum [Time Day 0 and days 7 and 15 after BCG intervention] 3. Change in Th1 and Th2 cytokines as assessed by RT-PCR using RNA extracted from hematocrit [Time Day 0 and days 7 and 15 after BCG intervention]Timepoint: 1. Change in IgG and IgM induced by nCoV-19 in serum [Time Day 0 and days 7 and 15 after BCG intervention] 2. Change in total IgG and IgM levels in serum [Time Day 0 and days 7 and 15 after BCG intervention] 3. Change in Th1 and Th2 cytokines as assessed by RT-PCR using RNA extracted from hematocrit [Time Day 0 and days 7 and 15 after BCG intervention];1.Local and systemic adverse events to BCG vaccination. [Time Enrolment to 3 months] 2.No. of ICU admissions [Time Enrolment to 3 months] 3.Duration of ICU admission [Time Enrolment to 3 months] 4.Number of participants needing mechanical ventilation [Time Enrolment to 3 months] 5.Duration of Mechanical ventilation [Time Enrolment to 3 months] 6.Mortality [Time From enrolment] 7.Time for resolution of COVID-19 disease [Time From enrollment] 8.Hospitalization cost [Time From enrollment]Timepoint: 1.Local and systemic adverse events to BCG vaccination. [Time Enrolment to 3 months] 2.No. of ICU admissions [Time Enrolment to 3 months] 3.Duration of ICU admission [Time Enrolment to 3 months] 4.Number of participants needing mechanical ventilation [Time Enrolment to 3 months] 5.Duration of Mechanical ventilation [Time Enrolment to 3 months] 6.Mortality [Time From enrolment] 7.Time for resolution of COVID-19 disease [Time From enrollment] 8.Hospitalization cost [Time From enrollment]	—

Measure

Time frame

1. Change in IgG and IgM induced by nCoV-19 in serum [Time Day 0 and days 7 and 15 after BCG intervention] 2. Change in total IgG and IgM levels in serum [Time Day 0 and days 7 and 15 after BCG intervention] 3. Change in Th1 and Th2 cytokines as assessed by RT-PCR using RNA extracted from hematocrit [Time Day 0 and days 7 and 15 after BCG intervention]Timepoint: 1. Change in IgG and IgM induced by nCoV-19 in serum [Time Day 0 and days 7 and 15 after BCG intervention] 2. Change in total IgG and IgM levels in serum [Time Day 0 and days 7 and 15 after BCG intervention] 3. Change in Th1 and Th2 cytokines as assessed by RT-PCR using RNA extracted from hematocrit [Time Day 0 and days 7 and 15 after BCG intervention];1.Local and systemic adverse events to BCG vaccination. [Time Enrolment to 3 months] 2.No. of ICU admissions [Time Enrolment to 3 months] 3.Duration of ICU admission [Time Enrolment to 3 months] 4.Number of participants needing mechanical ventilation [Time Enrolment to 3 months] 5.Duration of Mechanical ventilation [Time Enrolment to 3 months] 6.Mortality [Time From enrolment] 7.Time for resolution of COVID-19 disease [Time From enrollment] 8.Hospitalization cost [Time From enrollment]Timepoint: 1.Local and systemic adverse events to BCG vaccination. [Time Enrolment to 3 months] 2.No. of ICU admissions [Time Enrolment to 3 months] 3.Duration of ICU admission [Time Enrolment to 3 months] 4.Number of participants needing mechanical ventilation [Time Enrolment to 3 months] 5.Duration of Mechanical ventilation [Time Enrolment to 3 months] 6.Mortality [Time From enrolment] 7.Time for resolution of COVID-19 disease [Time From enrollment] 8.Hospitalization cost [Time From enrollment]

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Countries

India

Contacts

Public ContactDr Sanjay Mukherjee

Haffkine Institute for Training, Research & Testing

u.padmanabhan@haffkineinstitute.org02224160947

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026