CONFIDENT
Trial question
What is the role of convalescent plasma for COVID-19-induced ARDS in mechanically ventilated patients?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
32.0% female
68.0% male
N = 475
475 patients (152 female, 323 male).
Inclusion criteria: adult patients with COVID-19-induced ARDS who had been receiving invasive mechanical ventilation for < 5 days.
Key exclusion criteria: pregnancy; previous episode of transfusion-related side effects; medical decision to limit therapy; participation in another COVID-19 trial.
Interventions
N=237 convalescent plasma (an infusion of 2 units of convalescent plasma with a neutralizing antibody titer of at least 1:320).
N=238 standard care (standard care alone without plasma).
Primary outcome
Rate of death by day 28
35.4%
45%
45.0 %
33.8 %
22.5 %
11.3 %
0.0 %
Convalescent
plasma
Standard
care
Significant
decrease ▼
NNT = 10
Significant decrease in the rate of death by day 28 (35.4% vs. 45%; RR 0.79, 95% CI 0.08 to 1.5).
Secondary outcomes
No significant difference in ventilator-associated pneumonia (76.8% vs. 79%; ARD -2.2, 95% CI -9.5 to 5).
Significant decrease in median SOFA score at day 7 (4 points vs. 5 points; AD -1 points, 95% CI -1 to 0).
No significant difference in use of vasopressors (81% vs. 85.7%; ARD -4.7, 95% CI -11.2 to 1.8).
Safety outcomes
No significant difference in serious adverse events.
Conclusion
In adult patients with COVID-19-induced ARDS who had been receiving invasive mechanical ventilation for < 5 days, convalescent plasma was superior to standard care with respect to the rate of death by day 28.
Reference
Benoît Misset, Michael Piagnerelli, Eric Hoste et al. Convalescent Plasma for Covid-19-Induced ARDS in Mechanically Ventilated Patients. N Engl J Med. 2023 Oct 26;389(17):1590-1600.
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