ICMR begins trials on Covid-19 patients to test plasma therapy's efficacy

Plan is to have 20-25 such trials across India under the apex health research institute

The Indian Council of Medical Research has commissioned clinical trials on patients across public hospitals to test the safety and efficacy of convalescent plasma therapy, in what can soon be recommended as a possible line of treatment.
 

One such trial sponsored by the ICMR is set to begin on 20 patients in Ahmedabad. The plan is to have 20-25 such trials across India.
 

Currently, there are no approved treatments for Covid-19. The disease is being managed with supplemental oxygen and mechanical ventilation apart from treatment offered on case-to-case basis depending on co-morbidities.

This lack of a clear line of treatment is what is making the disease dreaded across the globe. Several treatment strategies are being tested across the world, including the use of a protein called Interferon alpha-2b that is expected to reduce the viral load.

Trials commissioned by ICMR, the country’s apex health research organisation, are critical to arrive at an approved line of treatment.
 

What is plasma therapy?
 

In this procedure, plasma from a Covid-19 patient who has recovered from the disease is transfused into another critically ill patient. The idea is to transfer the immunity (or antibodies) from a healthy person to a sick one so that the latter’s body develops antibodies to fight the disease.
 

Recently, India’s central drug regulator has allowed ICMR for clinical trial of convalescent plasma in patients. Following this, ICMR sought participation from institutions for randomised phase II controlled trial to assess the safety and efficacy of the therapy.

So far, about 99 institutions have shown interest to study how safe and efficient plasma therapy is in treating Covid-19 patients.
 

A government source indicated that such ICMR-commissioned trials would be conducted across the country in order to arrive at a conclusion. Public health experts say unless all trials are completed and show positive benefit or evidence of harm, the line of treatment cannot be approved.
 

Now, ICMR has signed a memorandum of understanding (MoU) with Ahmedabad-based SVP hospital, making the latter the first in the country to initiate the ICMR-sponsored trials. Sources said the collaborative trial is being partly funded by ICMR and by the Centre.
 

“There are other states that have begun this therapy on their own. But SVP in Ahmedabad is the first such centre to be now recognised and sponsored by ICMR to conduct clinical trials.

The local administration had fast-tracked the application and finished all necessary paperwork with our ethical committee even approving the MoU latest by Sunday night,” said Dr Pratik Patel, dean of NHL Municipal Medical College, of which SVP forms a part.

Run by the Ahmedabad Municipal Corporation (AMC) Sardar Vallabhbhai Patel Institute of Medical Sciences and Research (SVPIMSR) is a 1,500-bed multi-speciality hospital and medical college. ICMR has laid out protocols for inclusion and exclusion of patients.
 

“The idea is to select such 20-25 centres across the country, of which SVP hospital is the first. Tentatively, 20 patients will be selected for clinical trials based on ICMR protocols,” he said.
 

At present an individual clinician can use plasma therapy to treat a patient under ‘compassionate use programme’. A 49-year-old man in Delhi’s Max Hospital has shown positive results. He was the first one to be administered plasma therapy.

Kerala, Maharashtra, Punjab have shown interest in using plasma therapy.
 

The HCG Bangalore Institute of Oncology has been granted permission by ICMR to begin clinical trials in order to evaluate the safety and efficacy of convalescent plasma therapy for Covid-19 treatment.  Batting for the therapy Karnataka Medical Education Minister K Sudhakar said the therapy holds great promise in treating Covid-19 patients.
 

Pharma industry experts such as Biocon’s CMD Kiran Mazumdar Shaw have also backed plasma therapy suggesting the country needs to accelerate it to combat the virus.

In another development, a team of scientists from European Medical Association together with molecular diagnostics company Redcliffe Lifesciences and data analytics organisation Sapio Analytics have brought a novel treatment to India combining plasma therapy with ion therapy to treat Covid-19 patients.

The team claims it is proven to cure Covid-19 within 48 hours with higher effectiveness than conventional plasma treatment.
 

“The treatment has already been applied in China and Germany, with successful results, proving to be about 10 times more effective than conventional plasma therapy, with recovery rate of severe and acute patients being less than 48 hours,” said the innovators.

The group is in the process of seeking approvals from ICMR and other authorities in order to start off clinical trials in India.