Coronavirus Outbreak: Kerala to start clinical trial of plasma therapy by April-end, awaits approval from Drug Controller of India
Thiruvananthapuram: Kerala is set to become the first state in the country to commence convalescent plasma therapy, which uses antibodies from the blood of cured patients, to treat critically ill COVID-19 cases on a trial basis.
The Indian Council of Medical Research (ICMR) has given its nod to the state government for the first of its kind project, initiated by the prestigious Sree Chitra Tirunal Institute for Medical Sciences and Technology (SCTIMST), a top official said.
SCTIMST, an Institution of National Importance under the Union Department of Science and Technology, is expecting to start the trials by this month end once the required approvals from the Drugs Controller of India and the Ethics committee are received.
"We have received the approval from the Indian Council of Medical Research (ICMR) to conduct it as a clinical trial", Director of the city-based institute Dr Asha Kishore told PTI.
"This is a form of convalescent plasma therapy. The technique is to use (blood) plasma of patients who have completely recovered from COVID-19 as it will be rich in antibodies", she said.
In COVID-19, some small studies have been done in China and United States where they had tried this treatment method -- taking the plasma of a patient who is cured and whose blood contains lot of antibodies to fight the virus, she said.
Their plasma is collected and infused into COVID-19 patients who are critically ill and whose immune system cannot fight the virus.
"We do not have strong evidence that it works. So it will be tested in the form of a clinical trial to see whether it will work or not", the Director said adding they were trying to get Corporate Social Responsibility (CSR) funds for the project, which is estimated to cost Rs 25 lakh.
The project has been approved by the state government and five medical colleges -- at Thiruvananthapuram, Alapuzha, Ernakulam, Thrissur and Kannur -- and an expert form COVID-19 clinic in Kozhikode, Dr Anoop, who will do the clinical follow up, will be participating in it.
"We will monitor the "Plasma Pheresis"-- a technique of collecting the blood of patients and separating the plasma from blood cells. SCTIMST is awaiting the approval of Drugs Controller of India (DCI) for this kind of blood donation as the stringent criteria of regular blood donation will have to be relaxed for this exceptional situation," she said.
Once the DCI approval was received, the ethics committee will be approached to give its nod, Asha said.
"We are collaborating with state hospitals, COVID-19 cell and the institute's transfusion medicine department.So we will together conduct the study when we get approvals", she said.
This has to be a voluntary donation from the patients who have recovered from the disease.
"Their swab sample has to be clear 3 times before they are called clear and they have to wait for two weeks quarantine to be over only after which their blood will be collected for "plasma pheresis" process, the director explained.
The plasma can be collected, stored and kept and given whenever a critically ill patient does not respond to anything else, she said.
Asha said they were hoping to get the required approvals by next week after which all logistics will be arranged.
Patients who have recovered will have to be contacted, counselled, get their informed consent and bring them to blood banks in the five medical colleges.
"We hope to start by the end of this month. Their blood will be tested for HIV, Hepatitis and all procedures would be followed only after which plasma would be taken from their blood," she added.
Asked if patients had been contacted by the institute, she said, the state government has the list of the patients, and once all the approvals are received, the government would hand over to them.
The SCTIMST focuses on high quality, advanced treatment of cardiac and neurological disorders, indigenous development of technologies for biomedical devices and materials and public health training and research.
Updated Date: Apr 09, 2020 20:04:39 IST
Tags : Alapuzha, Blood, Coronavirus, Coronavirus Outbreak, Coronavirus Treatment, COVID-19, COVID-19 Treatment, DCI, Drugs Controller Of India, Ernakulam, ICMR, Kannur, Kerala, Kozhikode, Plasma Pheresis, Plasma Therapy, SCTIMST, Sree Chitra Tirunal Institute For Medical Sciences And Technology, Thiruvananthapuram, Thrissur
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