Evaluation of BCG as potential therapy for COVID-19

Phase 2

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

Registration Number: CTRI/2020/05/025013

Lead Sponsor: Medical Education and Drugs Department

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

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

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures