Hospital in Karnataka gets nod for plasma therapy trials

HCG Hospitals to start trials; plasma to be collected from recovered patients at Victoria Hospital

April 22, 2020 12:08 am | Updated 12:11 am IST - Bengaluru

Bringing hope to the battle against COVID-19, the Central Drugs Control Organisation under the Director General of Health Services has approved a research proposal from a hospital in Karnataka to study the use of convalescent plasma therapy in treating COVID-19.

The therapy that holds promise in treatment of COVID-19 cases will be tested on at least 10 critical patients in the State in the initial phase. Following the approval granted to HCG Hospitals, trials will begin on critical COVID-19 patients who are currently in ICU and on ventilators using plasma from patients who recovered from Victoria Hospital.

Jawaid Akhtar, Additional Chief Secretary (Health and Family Welfare), said following the approval, U.S. Vishal Rao, oncologist at HCG and public health expert, would get into an agreement with Victoria Hospital for taking up the trials.

“It will be taken up in collaboration with the State government for the benefit of our patients,” he said.

Dr. Rao said the therapy could be used in the category of patients who are battling the disease along with severe comorbidities and respiratory distress. “We have planned a Phase I/II, Open Label, parallel arm clinical trial to assess the safety and efficacy of this therapy in COVID-19 infected patients for free,” he said.

The approval has been granted under the provisions of the New Drugs and Clinical Trial Rules, 2019.

Describing how the therapy works, Dr. Rao said, “The idea behind this therapy is that immunity can be transferred from a healthy person to a sick patient using convalescent plasma. This therapy uses antibodies from the blood of a recovered COVID-19 patient to treat another critical patient. The recovered patient’s blood develops antibodies to battle against 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,” Dr. Rao explained.

Ashish Dhoot, immunohematologist at HCG, said the plan is to collect 500 ml of plasma from recovered patients from Victoria Hospital and use it on critical patients whose blood group is compatible with the donor’s plasma. “We will first collect a sample and test it before asking the patients to come to the blood bank and donate the plasma,” he said, and added that collected plasma from recovered patients would be stored for use on other patients in future.

Use of convalescent plasma has been studied in outbreaks of other respiratory infections, including the 2003 SARS-CoV-1 epidemic, the 2009-2010 H1N1 influenza virus pandemic, and the 2012 MERS-CoV epidemic.

In India, currently there is one more registered trial for the same therapy, by Government Medical College, New Delhi. Trials have also begun in Sree Chitra Tirunal Institute for Medical Sciences and Technology, Kerala.

Medical Education Minister K. Sudhakar said Bangalore Medical College and Research Institute had also sent a research request on behalf of COVID-19 hospitals in Bengaluru to Central agencies.

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