
Karnataka Medical Education Minister Dr K Sudhakar and Health Minister B Sriramulu symbolically launched the clinical trials for convalescent plasma therapy here on Saturday at Victoria Hospital in Bengaluru.
Two patients from the state who have recovered from COVID-19 will be donating their plasma at HCG Hospital on Monday. Their consent was taken and they were counselled today.
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"We have a separate building dedicated to recovered COVID-19 patients where they will donate their plasma. The recipient will be at Victoria. If there is any other patient who requires this across the state, they can be shifted to Victoria Hospital," said Dr Vishal Rao, Head and Neck Cancer Surgeon, HCG Hospital, who is the principle investigator of the clinical trial.
Explaining the agenda for the launch, Dr Rao, said, "The protocols had to be set, the donors needed to be identified, the standard operating procedures need to be planned and the final decisions on how we're going to execute it between the two institutes had to be made. We had to announce that we're kickstarting the programme so that donors could come forward and start donating blood and plasma so that people can be saved. That was the whole agenda."
Among the two donors who had agreed to donate plasma, one of them refused to come on a video call. But the other donor came on a video call and spoke to Medical Education Minister Dr K Sudhakar. The minister asked the donor over the video call, "Are you excited or happy?", to which the donor replied, "I'm both excited and happy. Even if I can help one person come out of this, I'll feel proud and humble. I'll do whatever it takes to ensure that all of us come out of this." Thanking the donor, Sudhakar said, "I wish more people who have healed come forward and help others who are infected."
Difference between clinical trials that HCG and BMCRI wants to do
Explaining the difference between the clinical trials that BMCRI and HCG want to do, Dr Rao said that HCG is doing a phase 1 clinical trial while BMCRI wants to do a phase 2 multicentric clinical trial (which will take four to six weeks to start). The trials have four phases. Whenever there is a new drug (plasma therapy is being considered a drug currently), it has to go through four phases. Phase 1 is safety -- which is done in 10-20 patients. Phase 2 is for testing efficacy, which is done in hundreds of patients. Phase 3 is one where one study is compared with another done in the past, and phase 4 is for surveillance where post recovery and lockdown, recovered patients are monitored on how they are faring in the community.
HCG is currently doing a phase 1 trial which is being done only in three places across the world -- Chicago university in the US, Hungary and Karnataka. ICMR has also come out with a protocol for phase 2 clinical trial for 452 patients.
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