New Delhi: Arthritis drug tocilizumab increases the chances of survival for patients suffering from severe Covid-19, an Indian study in The Lancet journal has found.
The phase 3 trial data, published in The Lancet Respiratory Medicine, has been authored by 20 researchers including Dr Arvinder S. Soin from Medanta, Dr Rajesh Chawla from Apollo Hospitals and D. Manoj Goel from Fortis Hospitals.
According to the researchers, the COVID India Tocilizumab (COVINTOC) trial is the first randomised controlled trial of tocilizumab for Covid-19 done entirely in a lower-middle-income country (LMIC).
The study stated that the consumption of drug, manufactured by Swiss drugmaker Roche, showed no difference in deaths or ventilator use among two groups of patients when moderate and severe categories of patients were studied together.
However, a sub-group analysis of severe patients showed lower mortality among those who received Tocilizumab and those who did not.
According to the study, published Thursday, the proportion of patients whose disease progressed — from moderate to severe or severe to death — in 28 days was 12 per cent (11 of 91) in the tocilizumab group and was 18 per cent (16 of 88) in the standard care group.
Meanwhile, among the subset of patients who had severe Covid-19, the proportion of patients whose disease progressed to death in 28 days was 16 per cent (eight of 50) in the the tocilizumab group and 34 per cent (14 of 41) in the standard care group.
The study was funded by the Medanta Institute of Education and Research, Roche India, Cipla India, and Action COVID-19 India, a not-for-profit initiative of venture capital firms and startup founders who are working on solutions to fight the coronavirus in India.
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Routine use of the drug not supported, says study
The study was aimed to investigate if tocilizumab could prevent the progression of Covid-19.
The researchers noted that previous global randomised controlled trials of the arthritis drug have shown conflicting results on hospitalised Covid patients but it has displayed potential to decrease the time to discharge and the burden on intensive care.
According to them, tocilizumab has also shown reduced progression to mechanical ventilation and death in a trial population made up of racial and ethnic minorities.
A total of 180 patients were recruited for the study from 12 public and private hospitals across India. Of these, 90 patients received tocilizumab and standard care while the remaining 90 received only standard care.
Furthermore, one patient randomly assigned to the standard care group inadvertently received tocilizumab at baseline and was included in the tocilizumab group for all analyses.
Another patient randomly assigned to the standard care group withdrew consent after the baseline visit and did not receive any study medication and was not included in the modified intention-to-treat population but was still included in safety analyses.
The study showed that 75 of 91 in the tocilizumab group and 68 of 89 in the standard care group completed 28 days of follow-up.
However, the study concluded that the routine use of tocilizumab in patients admitted to hospital with moderate to severe Covid-19 is not supported but the researchers state that the drug should to investigated further.
“However, post-hoc evidence from this study suggests tocilizumab might still be effective in patients with severe COVID-19 and so should be investigated further in future studies,” the study said.
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