HCG gets DCGI permission for clinical trial to evaluate safety and efficacy of CP therapy for COVID-19 patients

Oncology major HCG has received permission from the Drugs Controller General of India (DCGI), under the provisions of New Drugs and Clinical Trial Rules, 2019 to begin clinical trials of the proposed convalescent plasma (CP) therapy to treat COVID-19.

HCG’s clinical team led by Dr Vishal Rao, associate dean, Centre of Academics and Research; Dr. Gururaj A Rao, director, iCrest of HCG; Dr Jyothsna Rao, research director and immunologist, and Dr. Ashish Dhoot, consultant and head, blood bank and stem cells, have been working to suggest a possible successful treatment option for COVID-19 cases.

CP therapy is an experimental procedure for COVID-19 patients where plasma from a COVID-19 patient who has recovered from the disease is transfused into a critically ill patient.

The research began during the initial days of the COVID scare, when Dr. Gururaj decided to find out a way to treat virus infected patients with plasma therapy.

The passive antibody therapy, through transfusion of convalescent plasma, may prevent clinical infection or blunt clinical severity in individuals with recent pathogen exposure. Antibody therapy can also be used to treat patients who are already manifesting symptoms of varying severity, he added.

“The idea behind this therapy is that immunity can be transferred from a healthy person to a sick patient using convalescent CP. The recovered COVID-19 patient’s blood develops antibodies to battle COVID-19. Once the blood of the first patient is infused to the second patient, those antibodies will start fighting against coronavirus in the second person, said Dr Vishal.

“We have submitted three protocols to DCGI and ICMR. These are – cell-derived cytokine therapy trial for early stage COVID patients, mesenchymal cell therapy clinical trial for moderate stage and convalescent plasma therapy clinical trial for severe stage, said Dr Gururaj.

“The concept of CP therapy was used for the ebola virus too. Hence, it makes sense to explore its utility on COVID-19 patients,” he said

According to HCG, it was after several reviews by the DCGI and the ICMR committee, we have been granted permission to start the clinical trial.
Supporting the clinical team’s effort to come up with a solution, Dr B S Ajaikumar, chairman & CEO said, “This is a considerable development in the given crisis. Our immunology team has been working tirelessly to create an evidence-based solution for clinical trials. Both the Union and Karnataka governments have supported the trial protocol. The trial will begin at the earliest in hospitals identified by the government. We will take a final decision on the effectiveness of the plasma therapy after the clinical trials are completed.”

Dr Ashish Dhoot, consultant and head, blood bank and stem cells, HCG said, “CP is a form of immuno-therapy wherein passive immunity is provided through focused immunoglobulins to patients with severe COVID-19 infection. If this therapy works in our clinical trial, it will provide a quick cure and reduce mortality and morbidity.