Arthritis drug tocilizumab has been found to reduce the risk of death among patients with severe Covid-19 in a phase 3 trial conducted in India.
However, the findings, published in the journal The Lancet Respiratory Medicine, does not support the routine use of tocilizumab in adults with Covid-19.
Explaining the results, the National Lead investigator and Chairman of the Medanta Liver Institute, Arvinder Soin said that this was the first phase 3 study to demonstrate that while routine use of tocilizumab on all hospitalised Covid patients was not warranted, the drug improved survival among patients with severe Covid-19.
Several well known public and private tertiary care hospitals from 10 Indian cities participated in the study.
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 MoHFW, were administered to patients in both groups.
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 per cent) among those who received Tocilizumab compared to those who did not (14/41; 34 per cent) at 28 days.
Tocilizumab was shown to be safe as the reported adverse events did not differ between the tocilizumab and standard care arms, said Soin.
Elaborating on the use of tocilizumab, Soin said given the conflicting results of the previous studies, millions were wasted last year on indiscriminate use of tocilizumab, since the exact stage of the disease in which to use the drug was not clear.
So, this study plugs an important gap in knowledge on Covid treatment and gives a clear direction on the timing of tocilizumab in Covid treatment.
“This research is instrumental in giving the medical fraternity clarity on when to use TCZ in Covid,” said Naresh Trehan, Managing Trustee of the Medanta Institute of Education and Research, and Chairman & Managing Director, Medanta.
“We have demonstrated that, even during a pandemic, it is possible to conduct a randomised controlled trial despite the multiple challenges and constraints encountered”.
In their paper, the investigators, brought out the difficulties encountered in conducting trials during the pandemic.
They were impeded by challenges such as changing standard care, administration of off-label treatments, rapidly evolving understanding of pathogenesis and treatment, multiple trials competing for participants, media hype, and the publication of non-peer reviewed reports.