DCGI grants approval to PGIMS to start clinical trials: COVID-19
The Drug Controller General of India (DCGI) has granted approval to Pt BD Sharma Postgraduate Institute of Medical Sciences (PGIMS), Rohtak in Haryana to start clinical trials on tuberculosis vaccine, the recombinant Bacillus Calmette Guerin (rBCG), for the treatment of COVID-19 patients.
Clinical trials are aimed to find out whether rBCG boosts immunity and can decrease the incidence or severity of symptoms in patients infected with COVID-19. These trials at PGIMS will be done on over 18 individuals who have come in contact with COVID-19 patients and include health care workers. They will be administered BCG vaccine and kept under observation for the next 180 days to find out its efficacy.
The BCG vaccine, introduced in the 1920s to fight TB, currently protects against tuberculosis (TB) and is administered to newborn infants in the country but clinical studies indicate vaccine’s ability to induce potent protection against other infectious diseases. The BCG vaccine contains a live but weakened strain of TB bacteria that provokes the body to develop antibodies to attack the bacteria.
Principal investigator for clinical trials and professor of pharmacology at the PGIMS, Rohtak, Dr Savita Verma informed that regulatory approvals from the ethics committee of the PGIMS have also been received to start the clinical trials. Due to the capacity of BCG to reduce the incidence of respiratory tract infections in children, the PGIMS research team hypothesise that this vaccination may induce some protection against the susceptibility to or severity of COVID-19.
Dr Verma said consent would be taken from COVID-19 patients attendants to be involved in the study. Thereafter, their samples would be collected. Clinical trials study new tests, treatments and evaluate their effects on human health outcomes. The trials are carefully designed, reviewed and completed, and need to be approved before they can start.