The Indian Council of Medical Research (ICMR) on May 17 announced to drop Convalescent plasma therapy (CPT) from the clinical protocol for the management of COVID-19 patients.
In plasma therapy, antibodies from the blood of an already recovered Covid-19 patient are used to help others recover.
The decision was implied after members of AIIMS- ICMR National Task Force along with the Health Ministry suggested that the plasma therapy used as a measure for covid patients treatment lacked effectiveness and was in several cases, used inappropriately.
In a meeting held on May 16, a day prior to the decision made, the task force said they were not in favor of continuing plasma therapy as part of the clinical management guidelines for coronavirus patients.
Considering the recommendation from the task force, the ICMR has dropped the use of convalescent plasma in the revised guidelines issued for clinical management of COVID-19.
In the earlier protocol, “off label” use of plasma therapy at the stage of early moderate disease was allowed, that is, within seven days of the onset of symptoms; and the availability of a high tier donor plasma.
The decision to replace the earlier guidelines with the new one comes in the backdrop of some clinicians and scientists writing to Principal Scientific Advisor K Vijay Raghavan along with ICMR chief Balram Bhargava and AIIMS Director Randeep Guleria, cautioning against the non-scientific and irrational use of convalescent plasma therapy for COVID-19 in the country.
According to the letter signed by surgeon Pramesh C S and vaccinologist Gagandeep Kang, this raises the possibility of more virulent strains developing due to irrational use of plasma therapy which can fuel the pandemic.
The letter also urged the intervention to address the issues so as to prevent harassment of COVID-19 patients along with their families and children, their clinicians, and COVID-19 recovered survivors.
It further added that the current research evidence unanimously indicates that for the treatment of Covid-19, there is no benefit offered by convalescent plasma. However, it continues to be prescribed widespread in hospitals across India.
Families of patients are forced to move in and out asking for sources in order to get plasma, already in short supply. The desperation of patients and their families is understood because they like to try the best for their loved and ones when a doctor has prescribed this, the public health professionals said.
India’s largest trial PLACID, which was the world’s first randomized controlled trial on convalescent plasma in 39 public and private hospitals across India has earlier found that plasma therapy was ineffective in arresting Covid-19. The trial with high generalisability approximated convalescent plasma use in real-life settings with limited laboratory capacity.
The large trial which was conducted on 11,588 patients found no difference in death or proportion of patients discharged from hospital, as mentioned by the clinicians in the letter.
They pointed out that there was no difference even for those patients who were not on ventilation initially, in the proportion meeting the composite endpoint of progression to invasive mechanical ventilation or death”, they pointed out.
The health professionals added that the Plasma trial in Argentina and few studies in China and Netherlands concluded that there is no significant difference in clinical status or overall mortality between patients treated with convalescent plasma therapy and those who received a placebo instead.