COVID-19: Kerala Gets ICMR Nod for Plasma Therapy

With the highest recovery rate and low mortality from the novel coronavirus, Kerala is also set to become the first state in the country to begin convalescent plasma therapy – the use of antibodies from the blood of cured patients to treat those critically ill from COVID-19 on trial.

The Indian Council of Medical Research (ICMR) has given its nod to the state government for the 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 begin trials from April-end, once the required approvals from the Drugs Controller of India and the Ethics committee are received.

“We have received approval from the Indian Council of Medical Research (ICMR) to conduct it as a clinical trial,” Dr Asha Kishore, Director of the city-based institute 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.

Some small studies have been done in China and the United States where doctors 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.

Kerala’s exploration is inspired by a study by doctors in China whose findings have been published in the Journal of the American Medical Association. In the Chinese trial, the plasma of recovered individuals was transferred to five critical patients and the condition of the patients had improved following the transfusion.

“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.

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The project has already been approved by the state government and five medical colleges at Thiruvananthapuram, Alapuzha, Ernakulam, Thrissur and Kannur will be participants. An expert from the COVID clinic in Kozhikode, Dr. Anoop, who will do the clinical follow up, will also be a part of the project.

“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 is received, the ethics committee will be approached to give its nod, Asha said.

“We are collaborating with state hospitals, COVID cell and the institute's transfusion medicine department. So we will together conduct the study when we get approvals,” she said.

It has to be a voluntary donation from 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’, 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.

Patients who have recovered will have to be contacted and counselled since their informed consent is needed to 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 that the state government has the list of the patients, and once all the approvals are received, the government would hand it over to them.

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124 People Cured So Far:

On Friday, seven more people tested positive for COVID-19 in Kerala, taking the total number of active cases in the state to 238. Kerala Health minister K.K. Shailaja said 124 people have been cured of the infection so far, including 27 on Friday.

Of the seven cases, three are from the worst affected Kasaragod and two each from Kannur and Malappuram districts, a press release quoting the minister said.

Five people had contracted the infection through contacts, of which two are from Kannur and three from Kasaragod.

Since the detection of the first case in the state on January 30, samples of 124, of whom 37 were from Kannur, 24 from Kasaragod and eight foreigners, have turned negative so far and have been discharged, the release said.

In the first phase, India's first three coronavirus positive cases, all students from Wuhan, had tested positive for the virus. They have been treated and discharged.

The number of virus cases has increased in the state since March 8, with 364 people having tested positive so far.

At least 1,29,751 people are under observation in various hospitals, including 730 in hospitals. On Friday, 126 people were admitted to hospitals.

Samples of 13,339 people with virus symptoms had been sent for testing, of which 12,335 have returned negative, the release added.