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Experts contest Centre’s move to remove CP therapy from national clinical management protocol for COVID-19

Shardul Nautiyal, Mumbai
Monday, October 26, 2020, 08:00 Hrs  [IST]

Even as the Central government is considering to remove convalescent plasma (CP) therapy from the national clinical management protocol for COVID-19, experts and clinicians have contested that clinical trial studies to prove the efficacy of CP therapy are still ongoing and need some more time to arrive at the right conclusion in the interest of patient safety.

This comes close on the heels of Maharashtra health ministry also mulling over the plan to set up plasma banks in the state, the policy framework of which is being worked out in consultation with blood banking experts and clinicians.

A stakeholders meeting on the same is scheduled to be held very soon with Maharashtra health department towards popularizing CP therapy for saving vulnerable patient population of COVID-19.

Experts have also been recommending time and again that the Central Drugs Standard Control Organization (CDSCO) needs to fast-track approvals for setting up plasma banks to boost clinical trials and therapy for COVID-19. The plasma donor has to be a person who has recovered from COVID-19 at least 2 to 3 weeks back and have significant antibody titre and two molecular negative test reports. Plasmapheresis is a process in which the liquid part of the blood, or plasma, is separated from the blood cells. Typically, the plasma is replaced with another solution such as saline or albumin, or the plasma is treated and then returned to the body.

A COVID-19 patient requires 400 ml of plasma and plasmapheresis gives 500 ml of plasma in one sitting as a maximum collection granted by FDA from a human blood while component separation centrifuge method from whole blood gives 200 ml in one sitting or session. As per Indian Council of Medical Research (ICMR) guidelines issued on June 13, 2020, plasma collection should be done by centrifugal separation using an apheresis machine or equipment at the healthcare facility.

In Mumbai, there are roughly 14 plasma banks and 25 in Maharashtra. In the country, there are around 60 blood banks which have put a glimmer of hope for the patients who only have the option of availing CP therapy.

"The Federation of Bombay Blood Banks (FBBB) has sought price revision from state health ministry on single donor CP as proposed price cap of Rs. 5,500 per unit of plasma is unfeasible for COVID-19 treatment. Blood banks have extensively discussed and arrived at a costing of Rs. 7,000 per unit of 200 ml in the larger public interest," said Dr. Abhijit Bopardikar, Joint Secretary, FBBB.

According to official sources, plasma banks have been set up in Delhi, Kolkata, Punjab, Rajasthan and Mumbai.

CP therapy has gained a lot of prominence in the country amidst growing demand for emergency use authorized (EUA) medicines like remdesivir and tocilizumab among other expensive drugs. Clinicians strongly recommend CP therapy as a feasible one as plasma can be stored for a year at a temperature of minus 30 degree centigrade. Fresh frozen plasma (FFP) can be stored at temperatures > -30 degree centigrade according to national and international guidelines to maintain the stability of clotting factors and inhibitors.

Delhi government started the country’s first plasma bank at the Institute of Liver and Biliary Sciences (ILBS).

A plasma bank collects the blood component from an “eligible” recovered COVID patient. It is later infused in a patient through the convalescent plasma therapy. It helps bringing respiratory rate of a moderate COVID-19 patient into control and increases oxygen saturation rate apart from stabilising various other factors, reducing the stay in ICU and hospital and improving the recovery chances.

In China, clinical trials, a dose of 200 ml of CP with the neutralizing antibody titers above 1:640 was transfused to critical patient. There was improvement in clinical symptoms within three days. Radiological examination showed varying degrees of absorption of lung lesions within 7 days.

 

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