Key outcomes from randomized trials evaluating tocilizumab for the treatment of COVID-19
| Trial name | Study design | N patients (n tocilizumab) | Study population | Primary endpoints | Outcomes | Mortality |
| Benefit with tocilizumab shown | ||||||
| EMPACTA123 | Randomized prospective (double-blind) | 389 (194) | Severe disease | Death or MV by day 28 | Threshold for efficacy met (HR 0.56; 95% CI 0.32 to 0.97) | 28-day mortality 10.4% vs 8.6% aRD 2.0% (95% CI 5.2% to 7.8%) |
| CORIMUNO-TOCI-1121 | Randomized prospective | 131 (63) | Moderate/severe disease | Survival without NIV or MV by day 14; WHO-CPS score >5 on day 4 | Survival without NIV or MV threshold for efficacy met (HR 0.58; 90% CI 0.33 to 1.00); WHO-CPS score threshold for efficacy not met | 28-day mortality 11.1% vs 11.9% aHR 0.92 (95% CI 0.33 to 2.53) |
| REMAP-CAP124 | Adaptive platform | 895 (366)* | Severe disease | Respiratory and cardiovascular support-free days | Threshold for efficacy met OR 1.64 (95% CI 1.25 to 2.14) for tocilizuma; 1.76 (95% CI 1.17 to 2.91) | 90-day survival in anti-IL-6 HR 1.61 (95% CI 1.25 to 2.08) |
| RECOVERY125 | Randomized controlled platform trial (open label) | 4166 (2022) | Severe disease | 28-day mortality | Threshold for efficacy met RR 0.86 (95% CI 0.77 to 0.96) | 28-day mortality 29% vs 33% |
| No benefit shown with tocilizumab | ||||||
| COVACTA127 | Randomized prospective (double-blind) | 450 (225) | Severe/critical disease | Difference in clinical status at day 28 | Threshold for efficacy not met OR 1.19 (95% CI 0.81 to 1.76) | 19.7% vs 19.4% ARD 0.3% (95% CI 7.6% to 8.2%) |
| RCT-TCZ-COVID-19137 | Randomized prospective | 126 (60) | Severe disease | Clinical worsening defined as PaO2:FiO2 <150 mm Hg, ICU admission, or death | Threshold for efficacy not met RR 1.05 (95% CI 0.59 to 1.86) | 3.3% vs 1.6% RR 2.10 (95% CI 0.20 to 22.6) |
| TOCIBRAS129 | Randomized prospective (open-label) | 129 (65) | Severe disease | Clinical status on day 15 after randomization on a 7-point ordinal scale† | Threshold for efficacy not met OR 1.54 (95% CI 0.66 to 3.66; p=0.32 | 15-day mortality 17% vs 3% (OR 6.42; 95% CI 1.59 to 43.2) |
| BACC Bay128 | Randomized (double-blind) | 253 (141) | Moderate disease | Intubation or death; disease worsening | Intubation or death HR 0.83 (95% CI 0.38 to 1.81; p=0.64) Disease worsening HR 1.11 (95% CI 0.59 to 2.10; p=0.73) | 10.6% vs 12.5% HR 0.83 (95% CI 0.38 to 1.81) |
*The results reported to date for the REMAP-CAP study include patients enrolled for both tocilizumab (n=366) and sarilumab (n=48) treatment. Thresholds for efficacy were met in both groups.
†The primary outcome, clinical status measured at 15 days using a seven-level ordinal scale, was analyzed as a composite of death or mechanical ventilation because the assumption of odds proportionality was not met.
aHR, adjusted HR; aRD, adjusted risk difference; ICU, intensive care unit; IL, interleukin; MV, mechanical ventilation; NIV, non-invasive ventilation; RR, risk ratio; WHO-CPS, World Health Organization Clinical Progression Scale.