Table 7.
Selected randomized controlled trials comparing the efficacy of tocilizumab and control group(s).
| Randomized Controlled Trials | Patient Characteristics | Comparison groups | Number of patients included | Primary Outcome Measure | Main results |
|---|---|---|---|---|---|
| Recovery Collaborative Group, Horby P et al. [78] | Hospitalized COVID-19 patients with hypoxia and systemic inflammation | Tocilizumab+ usual standard of care vs. usual standard of care | 2022 vs. 2094 | 28-day mortality | 29% vs. 33%; RR: 0.86; 95% CI, 0.77–0.96; p: 0.007 |
| REMAP-CAP Trial, Gordon et al. [79] | Hospitalized patients with COVID-19 within 24 hours of commencing organ support in an intensive care unit | Tocilizumab vs. sarilumab vs. standard care | 353 vs. 48 vs. 402 | Ordinal scale combining in-hospital mortality and days free of organ support to day 21 | Median organ support free days, 10 (IQR: −1 to 16) vs. 11 (IQR: −1 to 16) vs. 0 (IQR: −1 to 15); median adjusted OR: 1.64; 95% credible intervals [CrI], 1.25–2.14 for tocilizumab and 1.76; 95%CrI, 1.17–2.91 for sarilumab |
| Hermine et al. [80] | Patients with COVID-19 and moderate or severe pneumonia requiring at least 3 L/min of oxygen but without ventilation or admission to the intensive care unit | Tocilizumab+ usual care vs. usual care | 64 vs. 67 | Scores higher than 5 on the World Health Organization 10-point clinical progression scale on day 4 and survival without need of ventilation (including noninvasive ventilation) at day 14 | Median posterior absolute risk difference: −9.0%; 90% credible interval, −21.0 to 3.1, with a posterior probability of negative ARD of 89.0% 24% vs. 36%, median posterior HR, 0.58; 90% credible intervals, 0.33–1.00 |
| Salvarani et al. [81] | Patients with COVID-19 pneumonia documented by radiologic imaging, partial pressure of arterial oxygen to fraction of inspired oxygen ratio between 200 and 300 mm Hg, and an inflammatory phenotype defined by fever and elevated C-reactive protein | Tocilizumab vs. control | 60 vs. 63 | Entry into the intensive care unit with invasive mechanical ventilation, death from all causes, or clinical aggravation | 28.3% vs. 27.0%; RR: 1.05; 95% CI, 0.59–1.86 |
| EMPACTA trial Salama et al. [84] | Patients hospitalized with COVID-19 pneumonia who were not receiving mechanical ventilation | Tocilizumab vs. placebo | 249 vs. 128 | Mechanical ventilation or death by day 28. | 12.0% vs. 19.3%; HR: 0.56; 95% CI, 0.33–0.97; p: 0.04 |
| Stone et al. [82] | Patients with laboratory confirmed COVID-19 hyperinflammatory states, and at least two of the following signs: fever (body temperature >38°C), pulmonary infiltrates, or the need for supplemental oxygen | Tocilizumab vs. placebo | 161 vs. 82 | Intubation or death, assessed in a time-to-event analysis | HR: 0.83; 0.38–1.81; p: 0.64 |
| Rosas et al. [85] | Patients hospitalized with severe COVID-19 pneumonia | Tocilizumab vs. placebo | 294 vs. 144 | Clinical status on a 7-category ordinal scale at day 28 | 1.0 (1.0 to 1.0) vs. 2.0 (1.0 to 4.0); OR: 1.19; 95% CI, 0.81–1.76; p: 0.36 |
| Veiga et al. [83] | Patients hospitalized with severe or critical COVID-19 pneumonia | Tocilizumab+ standard of care vs. standard of care | 65 vs. 64 | A composite of death or mechanical ventilation at 15 days | 28% vs. 20.0%; OR: 1.54; 95% CI, 0.66–3.66; p: 0.32 |
Abbreviations: COVID-19, coronavirus diseases 2019; RR, rate ratio; OR, odds ratio; HR, hazard ratio; CI, confidence interval; PCR, polymerized chain reaction; SARS-CoV-2, Severe Acute Respiratory Syndrome Coronavirus-2; ARD, absolute risk difference; L, liter; min, minute.