PlasmAr
Trial question
What is the role of convalescent plasma in severe coronavirus 2019 pneumonia?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
32.0% female
68.0% male
N = 333
333 patients (108 female, 225 male).
Inclusion criteria: hospitalized adult patients with SARS-CoV-2 pneumonia.
Key exclusion criteria: pregnancy or lactation, a history of blood component allergies, an infectious cause of pneumonia other than SARS-CoV-2, requirement for mechanical ventilation, multiorgan failure.
Interventions
N=228 convalescent plasma (a single administration of COVID-19 convalescent plasma in addition to standard treatment).
N=105 placebo (normal saline solution plus standard treatment).
Primary outcome
Death at 30 days
10.96%
11.43%
11.4 %
8.6 %
5.7 %
2.9 %
0.0 %
Convalescent
plasma
Placebo
No significant
difference ↔
No significant difference in death at 30 days (10.96% vs. 11.43%; ARD -0.46, 95% CI -7.8 to 6.8).
Secondary outcomes
No significant difference in median time from intervention to hospital discharge (13 days vs. 12 days; subHR 0.99, 99% CI 0.75 to 1.32).
No significant difference in median time from intervention to complete restoration of physical functions (15 days vs. 15 days; subHR 0.89, 95% CI 0.66 to 1.18).
Safety outcomes
No significant difference in adverse and serious adverse events.
Significant difference in infusion-related adverse events (4.8% vs. 1.9%).
Conclusion
In hospitalized adult patients with SARS-CoV-2 pneumonia, convalescent plasma was not superior to placebo with respect to death at 30 days.
Reference
Ventura A Simonovich, Leandro D Burgos Pratx, Paula Scibona et al. A Randomized Trial of Convalescent Plasma in Covid-19 Severe Pneumonia. N Engl J Med. 2021 Feb 18;384(7):619-629.
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