medwireNews: The addition of tocilizumab to standard care does not reduce the risk for disease progression among hospitalized patients with moderate-to-severe COVID-19, suggest findings from the COVINTOC trial conducted in India.
However, post-hoc analysis of the study data demonstrated “the potential for tocilizumab to play a role in those severely ill with COVID-19, a finding subsequently replicated with stronger effect in REMAP-CAP and RECOVERY studies,” investigator Athimalaipet Ramanan (University Hospitals Bristol NHS Foundation Trust, UK) told medwireNews.
He added that the COVINTOC trial, “done across 12 hospitals in India, is a demonstration of ability to do [randomized controlled trials] in challenging settings.”
The open-label phase 3 study included 179 adults with confirmed SARS-CoV-2 infection and moderate-to-severe COVID-19 who were randomly assigned to receive a single intravenous infusion of tocilizumab 6 mg/kg (maximum dose 480 mg with a second dose permitted after 12 hours–7 days) in addition to local standard care, or to receive standard care only.
As reported in The Lancet Respiratory Medicine, the proportion of patients with progression of COVID-19 (from moderate to severe or from severe to death) between baseline and day 14 was comparable in the tocilizumab and control groups, at 9% and 13%, respectively.
The COVINTOC investigators, led by Arvinder Soin (Medanta–The Medicity Hospital, Gurugram, India), also found no significant between-group differences in a range of secondary endpoints, including rates of mechanical ventilation, mortality, and admission to the intensive care unit.
In a post-hoc analysis, COVID-19 progression rates during 28 days of follow-up were comparable in the tocilizumab and standard of care groups for the overall study population (12.1 vs 18.2%). However, they were significantly lower in the tocilizumab versus standard care arm when the analysis was restricted to the 91 patients with severe COVID-19 at baseline (16.0 vs 34.1%).
Taken together, these findings suggest “that tocilizumab is not an effective routine therapy for COVID-19 in all patients,” but people with more severe disease “might have a reduced risk for progression to death if treated with tocilizumab in addition to standard care,” write Soin et al.
“This information could help limit the scientifically unsubstantiated routine use of tocilizumab in all patients admitted to hospital with COVID-19 in resource-constrained countries such as India,” they add.
In all, 36% of tocilizumab-treated patients and 25% of those in the control group experienced adverse events (AEs), and 20% and 17%, respectively, experienced serious AEs. The most common serious AEs were acute respiratory distress syndrome, shock, cardiac disorders, and multiple organ dysfunction syndrome.
“Safety results were as expected on the basis of the known safety profile of tocilizumab and the disease manifestations of patients admitted to hospital with COVID-19,” say Soin and colleagues.
medwireNews is an independent medical news service provided by Springer Healthcare Ltd. © 2021 Springer Healthcare Ltd, part of the Springer Nature Group
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Lancet Respir Med 2021; doi:10.1016/S2213-2600(21)00081-3