PlasmAr Trial: Convalescent Plasma in Covid-19 Severe Pneumonia

Title of the Trial
PlasmAr: Convalescent Plasma in Covid-19 Severe Pneumonia
Year of Publication
2020
Objective
To assess if in patients with severe SARS-CoV-2 pneumonia, treatment with convalescent plasma would be associated with improved clinical outcomes at 30 days.
Number of Patients (N)
228
Inclusion Criteria
Hospitalized adults (at least 18 years of age) positive for SARS-CoV-2, radiologically confirmed pneumonia, no previous directives rejecting advanced life support, and at least one of the following severity criteria: oxygen saturation (SaO2) < 93% while they were at rest and breathing ambient air, PaO2:FiO2 of < 300 mm Hg, or a SOFA or modified SOFA score of two or more points above baseline status (scores range from 0 to 24, with higher scores indicating more severe disease).
Exclusion criteria
-pregnant or lactating,
-patients of reproductive age who were not willing to use contraceptive measures for a period of 30 days after enrollment,
-patients with a history of blood component allergies, an infectious cause of pneumonia other than SARS-CoV-2, a requirement for mechanical ventilation, multiorgan failure, or any other condition that would impede the provision of informed consent
Comparison groups
Convalescent Plasma (N=228) vs Placebo (N=105)
Primary Outcomes
clinical status at 30 days: OR 0.81 (0.50–1.31), P=0.396. The primary outcome, clinical status at 30 days, was similar between the two groups. Clinical status was defined by a 6-point ordinal scale.
Key Secondary Outcomes
Overall mortality: 11.0% vs. 11.4%
Median time to hospital discharge: 13 days vs. 12 days
Serious adverse event: 23.7% vs. 18.1%P=nonsignificant for all
Conclusion
No significant differences were observed in clinical status or overall mortality between patients treated with convalescent plasma and those who received placebo.
Citation, article link
Simonovich VA, Burgos Pratx LD, Scibona P, et al., on behalf of the PlasmAr Study Group. A Randomized Trial of Convalescent Plasma in Covid-19 Severe Pneumonia. Source