Progression of COVID-19 up to day 14 did not differ with addition of tocilizumab to standard care in Phase 3 trial conducted in India
THURSDAY, March 11, 2021 (HealthDay News) — Tocilizumab is not associated with progression of COVID-19 among adults admitted to hospital with moderate-to-severe COVID-19, according to a study published online March 4 in The Lancet Respiratory Medicine.
Arvinder S. Soin, from The Medicity Hospital in Gurugram, India, and colleagues conducted a multicenter, randomized, controlled phase 3 trial at 12 hospitals across India to examine whether tocilizumab could prevent COVID-19 progression. One hundred eighty adults admitted to hospital with moderate-to-severe COVID-19 were recruited between May 30, 2020, and Aug. 31, 2020, and were randomly assigned to receive either tocilizumab plus standard care or standard care alone (90 to each group). One patient randomly assigned to the standard care group inadvertently received tocilizumab.
The researchers found that progression of COVID-19 up to day 14 occurred in 9 and 13 percent of patients in the tocilizumab and standard care groups, respectively (difference, â3.71 percent; 95 percent confidence interval, â18.23 to 11.19 percent; P = 0.42). Adverse events occurred in 36 and 25 percent of patients in the tocilizumab and standard care groups, respectively, and serious adverse events occurred in 20 and 17 percent, respectively. Acute respiratory distress syndrome was the most common adverse event and was reported in 8 percent of patients in each group. Overall, 14 and 17 percent of patients in the tocilizumab and standard care groups, respectively, died during the study.
“Our study does not support the routine use of tocilizumab in adults with COVID-19,” the authors write. “However, there might be a role for it in patients with severe COVID-19 that should be defined further.”
One author disclosed financial ties to Roche; the study was partially funded and investigational medicinal product was supplied by Cipla and Roche India.
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