Efficacy of tocilizumab for hospitalized patients with COVID-19 pneumonia and high IL-6 levels: A randomized controlled trial.

Summary

In adults with severe COVID-19 pneumonia and IL-6 >40 pg/mL, tocilizumab added to standard care showed a non-significant reduction in death or invasive mechanical ventilation at 28 days, with trends toward fewer ventilation days and shorter hospital stay, and no serious safety signals. A meta-analysis within the study supported reduced risk of death or IMV with tocilizumab.

Key Findings

• Primary composite outcome (death or IMV by day 28) occurred in 12.9% with tocilizumab vs 32.3% with SOC (p=0.068).
• Trends toward fewer IMV days (7.5 vs 19.5; p=0.073) and shorter hospital stay (4 vs 8 days; p=0.134) with tocilizumab.
• No serious adverse events were reported in the tocilizumab arm.
• Study-conducted meta-analysis showed RR 0.83 (95% CI 0.77–0.89) for death or IMV with tocilizumab vs SOC.

Clinical Implications

In patients with severe COVID-19 and elevated IL-6, considering tocilizumab early may reduce progression to IMV or death, though larger multicenter RCTs are needed to confirm efficacy and refine IL-6 thresholds.

Limitations

• Open-label, single-center with small sample size (n=62), underpowered for primary endpoint.
• Primary outcome did not reach statistical significance; potential for selection and performance bias.

Future Directions

Conduct adequately powered, multicenter, blinded RCTs using predefined IL-6 thresholds and standardized co-interventions; explore timing, dosing, and patient phenotypes for maximal benefit.