EMPACTA
Trial question
What is the role of tocilizumab in patients hospitalized with COVID-19 pneumonia not undergoing mechanical ventilation?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
41.0% female
59.0% male
N = 377
377 patients (154 female, 223 male).
Inclusion criteria: patients hospitalized with COVID-19 pneumonia who were not receiving mechanical ventilation.
Key exclusion criteria: receiving CPAP, bilevel positive airway pressure, or mechanical ventilation; progression of the illness to death imminent and inevitable within 24 hours; active tuberculosis or suspected active bacterial, fungal, or viral infection (other than SARS-CoV-2 infection or well-controlled HIV infection).
Interventions
N=249 tocilizumab plus standard care (one or two doses of intravenous 8 mg/kg of body weight, to a maximum of 800 mg per dose).
N=128 placebo plus standard care (matching one or two intravenous doses of placebo).
Primary outcome
Rate of mechanical ventilation or death by day 28
12%
19.3%
19.3 %
14.5 %
9.7 %
4.8 %
0.0 %
Tocilizumab plus standard
care
Placebo plus standard
care
Significant
decrease ▼
NNT = 13
Significant decrease in the rate of mechanical ventilation or death by day 28 (12% vs. 19.3%; HR 0.56, 95% CI 0.33 to 0.97).
Secondary outcomes
No significant difference in median time to hospital discharge or readiness for discharge over 28-day period (6 days vs. 7.5 days; HR 1.16, 95% CI 0.91 to 1.48).
No significant difference in the rate of death by day 28 (10.4% vs. 8.6%).
Safety outcomes
No significant differences in overall adverse events, death, and progression of illness to category 6 on the seven-category ordinal scale.
Significant difference in serious adverse events (15.2% vs. 19.7%) and serious infections (5.2% vs. 7.1%).
Conclusion
In patients hospitalized with COVID-19 pneumonia who were not receiving mechanical ventilation, tocilizumab plus standard care was superior to placebo plus standard care with respect to the rate of mechanical ventilation or death by day 28.
Reference
Carlos Salama, Jian Han, Linda Yau et al. Tocilizumab in Patients Hospitalized with Covid-19 Pneumonia. N Engl J Med. 2021 Jan 7;384(1):20-30.
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