Table 3.
Overview of randomized controlled trials for interleukin 6 inhibitors with the benefit
| Study Type | Study Population | Interventions | Outcomes | Limitations | Conclusion | |
|---|---|---|---|---|---|---|
| RECOVERY56 | Open-label RCT | Hospitalized COVID-19 patients with hypoxia and a CRP ≥ 75 mg/L | 1:1 random assignment of tocilizumab 400–800 mg (n = 621) or placebo (n = 729) in addition to standard care | 28-day mortality: 31% vs 35% (RR 0.85, 95%CI, 0.76–0.94; P = 0.003) Hospital discharge within 28 days: 57% vs 50% (RR 1.22, 95% CI, 1.12–1.33;P < 0.0001) Receipt of mechanical ventilation or death: 35% vs 42% (RR0.84, 95% CI0.77–0.92;P < 0.0001) |
Open-label 16% of patients in tocilizumab actually did not receive treatment Random CRP cutoff |
Tocilizumab reduced the probability of progression to mechanical ventilation and/or death and increased the probability of hospital discharge within 28 days. |
| REMAP-CAP57 | Open-label adaptive platform RCT | Hospitalized patients with COVID-19 admitted in the ICU within 24 h after starting organ support | Random assignment of tocilizumab 8 mg/kg (n = 353), sarilumab 400 mg (n = 48), or standard care (n = 402) |
Tocilizumab vs control Median organ support free-days (IQR): 10 (−1 to 16) vs 0 (−1 to 15) In-hospital survival: 28% vs 36% (aOR 1.64; 95% credible interval 1.14–2.35) Sarilumab vs control Median organ support free-days (IQR): 11 (0 to 16) vs 0 (−1 to 15) In-hospital survival: 22% vs 36% (aOR 2.01; 95% credible interval 1.18–4.71) |
Open-label Control arm closed early |
Tocilizumab and sarilumab increased the amount of organ-free support days and reduced in-hospital mortality. |
| EMPACTA58 | Double-blind placebo-controlled RCT | Hospitalized patients with COVID-19 not receiving mechanical ventilation | 2:1 random assignment of tocilizumab 8 mg/kg (n = 249) or placebo (n = 128) in addition to standard care | Mechanical ventilation or death at day 28: 12% vs 19.3% (HR 0.56, 95% CI 0.33–0.97; P = 0.04) Death at day 28: 10.4% vs 8.6% (weighted difference 2 95% CI, −5.2 to 7.8) |
Sample size somewhat small especially in placebo group 9% of patients did not require oxygen at baseline, this population may not benefit from this therapy |
Tocilizumab reduced the need for mechanical ventilation but did not have an effect on mortality. |