IndiaThe Indian Council of Medical Research (ICMR) has givenits nod to the state government for the first of its kindproject, initiated by the prestigious Sree Chitra TirunalInstitute for Medical Sciences and Technology (SCTIMST), a topofficial said.
SCTIMST, an Institution of National Importance under theUnion Department of Science and Technology, is expecting tostart the trials by this month end once the required approvalsfrom the Drugs Controller of India and the Ethics committeeare received. "We have received the approval from the Indian Council ofMedical Research (ICMR) to conduct it as a clinical trial",Director of the city-based institute Dr Asha Kishore told .
"This is a form of convalescent plasma therapy. Thetechnique is to use (blood) plasma of patients who havecompletely recovered from COVID-19 as it will be rich inantibodies", she said.
In COVID-19, some small studies have been done in Chinaand United States where they had tried this treatment method-- taking the plasma of a patient who is cured and whose bloodcontains lot of antibodies to fight the virus, she said.
Their plasma is collected and infused into COVID-19patients who are critically ill and whose immune system cannotfight the virus.
"We do not have strong evidence that it works. So it willbe tested in the form of a clinical trial to see whether itwill work or not", the Director said adding they were tryingto get Corporate Social Responsibility (CSR) funds for theproject, which is estimated to cost Rs 25 lakh.
The project has been approved by the state government andfive medical colleges -- at Thiruvananthapuram, Alapuzha,Ernakulam, Thrissur and Kannur -- and an expert form COVIDclinic in Kozhikode, Dr Anoop, who will do the clinical followup, will be participating in it.
"We will monitor the "Plasma Pheresis"-- a technique ofcollecting the blood of patients and separating the plasmafrom blood cells. SCTIMST is awaiting the approval of DrugsController of India (DCI) for this kind of blood donation asthe stringent criteria of regular blood donation will have tobe relaxed for this exceptional situation," she said.
Once the DCI approval was received, the ethics committeewill be approached to give its nod, Asha said.
"We are collaborating with state hospitals, COVID celland the institute's transfusion medicine department.So we willtogether conduct the study when we get approvals", she said.
This has to be a voluntary donation from the patients whohave recovered from the disease.
"Their swab sample has to be clear 3 times before theyare called clear and they have to wait for two weeksquarantine to be over only after which their blood will becollected for "plasma pheresis" process, the directorexplained.
The plasma can be collected, stored and kept and givenwhenever a critically ill patient does not respond to anythingelse, she said.
Asha said they were hoping to get the required approvalsby 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 bloodbanks in the five medical colleges.
"We hope to start by the end of this month. Their bloodwill be tested for HIV, Hepatitis and all procedures would befollowed only after which plasma would be taken from theirblood," 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 wouldhand over to them.
The SCTIMST focuses on high quality, advanced treatmentof cardiac and neurological disorders, indigenous developmentof technologies for biomedical devices and materials andpublic health training and research. UDVS VS