BACC
Trial question
What is the effect of tocilizumab in moderately ill patients hospitalized with COVID-19?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
42.0% female
58.0% male
N = 243
243 patients (102 female, 141 male).
Inclusion criteria: patients with confirmed SARS-CoV-2 infection, hyperinflammatory states, and at least two of the following signs: fever, pulmonary infiltrates, or the need for supplemental oxygen in order to maintain oxygen saturation > 92%.
Key exclusion criteria: receipt of supplemental oxygen at a rate > 10 L/min, a recent history of treatment with biologic agents or small-molecule immunosuppressive therapy, receipt of other immunosuppressive therapy that would increase risk of infection, diverticulitis.
Interventions
N=161 tocilizumab (single dose of intravenous 8 mg per kg of body weight, not exceeding 800 mg plus standard care).
N=82 placebo (a matching single dose of intravenous placebo plus standard care).
Primary outcome
Intubation or death at day 28
10.6%
12.5%
12.5 %
9.4 %
6.3 %
3.1 %
0.0 %
Tocilizumab
Placebo
No significant
difference ↔
No significant difference in intubation or death at day 28 (10.6% vs. 12.5%; HR 0.83, 95% CI 0.38 to 1.81).
Secondary outcomes
No significant difference in clinical worsening of disease at 28 days (19.3% vs. 17.4%; HR 1.11, 95% CI 0.59 to 2.1).
No significant difference in median time to discontinuation of supplemental oxygen by 28 days (5 days vs. 4.9 days; HR 0.94, 95% CI 0.67 to 1.3).
No significant difference in mechanical ventilation (6.8% vs. 9.8%; HR 0.65, 95% CI 0.26 to 1.62).
Safety outcomes
No significant differences in death, MI, thrombocytopenia, bleeding, stroke, seizure, PE or DVT.
Significant differences in serious infections (8.1% vs. 17.1%), severe neutropenia (13.7% vs. 1.2%).
Conclusion
In patients with confirmed SARS-CoV-2 infection, hyperinflammatory states, and at least two of the following signs: fever, pulmonary infiltrates, or the need for supplemental oxygen in order to maintain oxygen saturation > 92%, tocilizumab was not superior to placebo with respect to intubation or death at day 28.
Reference
John H Stone, Matthew J Frigault, Naomi J Serling-Boyd et al. Efficacy of Tocilizumab in Patients Hospitalized with Covid-19. N Engl J Med. 2020 Dec 10;383(24):2333-2344.
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