Rohit Shishodia
India’s first randomized controlled study has revealed that the arthritis drug Tocilizumab reduces the risk of death among patients with severe Covid-19.

Eleven well known public and private tertiary care hospitals from 10 Indian cities were part of this study conducted from May 2020 to October 2020. A total of 180 patients were recruited, 90 of whom received Tocilizumab (TCZ) and standard care, whereas the other 90 received only standard care.

Steroids and Remdesivir, once allowed by the Union Health Ministry, were administered to patients in both arms. The results of the trial were published on March 6, 2021, in ‘The Lancet Respiratory Medicine’.

The National Lead Investigator and Chairman of the Medanta Liver Institute, Dr Arvinder Soin, said that this was the first phase 3 study to demonstrate that while routine use of TCZ on all hospitalized Covid patients was not warranted, TCZ improved survival among patients with severe Covid-19, he added.

“While there was no difference in mortality and need for ventilation among the two groups of patients when moderate and severe categories of patients were considered together, a subgroup analysis of the severe patients in the two groups showed a lower mortality (8/50; 16%) among those who received Tocilizumab compared to those who did not (14/41; 34%) at 28 days,” explained Dr Soin.

“TCZ was shown to be safe as the reported adverse events did not differ between the TCZ and standard care arms,” said Dr. Soin.

Dr Soin further said that given the conflicting results of the previous studies, millions were wasted last year on indiscriminate use of TCZ, since the exact stage of the disease in which to use the drug was not clear. Covid is not going away any time soon, he pointed out.

Dr Soin has emphasized that hence this study plugs an important gap in knowledge on Covid treatment and gives a clear direction on the timing of TCZ in Covid treatment. Incidentally, in the last month, two major studies - the Recovery Trial from UK and the Remap-CAP study – have revealed similar findings, that TCZ reduces mortality among patients with severe Covid,” he added.

“However, unlike our study, these are not yet published in peer-reviewed journals. Prompted by these findings, the NHS in the UK have now included TCZ as part of their standard treatment protocol of patients with severe Covid,” said Dr Soin.  

Dr Naresh Trehan, Managing Trustee of the Medanta Institute of Education and Research, and Chairman and Managing Director, Medanta, said, “This research is instrumental in giving the medical fraternity clarity on when to use TCZ in Covid. Becoming the first ones to provide published evidence of this to the world, we have demonstrated that, even during a pandemic, it is possible to conduct a randomised controlled trial despite the multiple challenges and constraints encountered.”