Table 3.
Randomized controlled trials – Trial design and results. Two values indicate tocilizumab; control group. HR, Hazard ratio; CI, confidence interval; CrI, credible interval; ARD, median absolute risk difference; OR, odds ratio; RR, rate ratio. MV, mechanical ventilation; HFO, high flow oxygen; NIV, noninvasive ventilation
BACC | COVACTA | EMPACTA | CORIMUNO-TOCI | TOCIBRAS | RCT-TCZ-COVID-19 | REMAP-CAP | RECOVERY | |
---|---|---|---|---|---|---|---|---|
Study duration | 28 days | 60 days | 60 days | 28 days | 29 days | 30 days | 21 | 28 days |
Dose | 8 mg/kg maximum 800 mg Single dose |
8 mg/kg maximum 800 mg Single dose |
8 mg/kg maximum 800 mg One or two doses |
8 mg/kg Second dose of 400mg/kg at day 3 if notimproved |
8mg/kg maximum 800 mg Single dose |
8 mg/kg maximum 800 mg Two doses |
8 mg/kg maximum 800 mg Second dose at physician discretion |
400–800 mg (weight based) Second dose at physician discretion |
Design | Double-blind placebo controlled | Double-blind placebo controlled | Double-blindplacebocontrolled | Open label | Open label | Open label | Open label Platform |
Open label Platform |
Primary outcome | Progression to intubation/death (HR 0.83, 95% CI 0.38–1.81) |
Clinical status at day 28 (difference −1; 95% CI −2.5–0) Post hoc analysis-Clinical failure in those not in the ICU at baseline (HR 0.61, 95% CI 0.4–0.94) |
MV or death at day 28 (HR 0.56, 95% CI 0.33–0.97) |
Death/NIV/MV day 4 ARD −9%, 90% CrI; −21%-3% Survival without NIV/MV at day 14 (HR 0.58; 95% CrI 0.33–1) |
Death/MV at day 15 OR 1.54 (95% CI 0.66–3.66) |
Clinical worsening by day 14, RR 1.05; 95% CI 0.59–1.86 |
Number of organ support free days Adjusted OR 1.64, 95% CrI 1.25–2.14 |
Mortality RR 0.82, 95% CI 0.78–0.98 |
Primary outcome met | No | No | Yes | Yes (one of two) | No | No | Yes | Yes |