Randomized Trial of Convalescent Plasma in COVID-19 Severe Pneumonia - PlasmAr

Dec 08, 2020
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Author/Summarized by Author:
Anthony A. Bavry, MD,MPH,FACC
Summary Reviewer:
Deepak L. Bhatt, MD, MPH, MBA, FACC
Date Published:
11/24/2020
Date Updated:
12/08/2020
Original Posted Date:
12/08/2020
References

Contribution To Literature:

The PlasmAr trial failed to show that convalescent plasma was superior to placebo at improving outcomes among hospitalized patients with SARS-CoV-2 infection.

Description:

The goal of the trial was to evaluate convalescent plasma compared with placebo among patients hospitalized with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection (COVID-19).

Study Design

  • Randomized
  • Parallel
  • Placebo

Patients hospitalized with SARS-CoV-2 infection were randomized to convalescent plasma (n = 228) versus placebo (n = 105).

  • Total number of enrollees: 333
  • Duration of follow-up: 30 days
  • Mean patient age: 63 years
  • Percentage female: 29%
  • Percentage with diabetes: 18%

Inclusion criteria:

  • Patients ≥18 years of age with SARS-CoV-2 infection requiring hospitalization
  • At least one severity criteria: oxygen saturation <93%, ratio of partial pressure of oxygen to fraction of inspired oxygen <300 mm Hg, or a Sequential Organ Failure Assessment (SOFA) or modified SOFA score ≥2 points

Exclusion criteria:

  • Pregnant or lactating
  • History of blood component allergies
  • Infectious cause of pneumonia other than SARS-CoV-2
  • Need for mechanical ventilation
  • Multiorgan failure

Other salient features/characteristics:

  • Median time from symptom onset to enrollment: 8 days

Principal Findings:

The primary outcome, clinical status at 30 days, was similar between the two groups (odds ratio 0.81, 95% confidence interval 0.50-1.31; p = 0.40). Clinical status was defined by a 6-point ordinal scale.

Secondary outcomes:

  • Overall mortality: 11.0% in the convalescent plasma group vs. 11.4% in the placebo group (p = nonsignificant)
  • Median time to hospital discharge: 13 days in the convalescent plasma group vs. 12 days in the placebo group (p = nonsignificant)
  • Serious adverse event: 23.7% in the convalescent plasma group vs. 18.1% in the placebo group (p = nonsignificant)

Interpretation:

Among patients hospitalized with SARS-CoV-2 infection, convalescent plasma was not beneficial. Convalescent plasma compared with placebo was not associated with an improvement in clinical status.

References:

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. N Engl J Med 2020;Nov 24:[Epub ahead of print].


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