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. Author manuscript; available in PMC: 2022 Nov 14.
Published in final edited form as: Crit Care Med. 2021 Jul 1;49(7):1015–1025. doi: 10.1097/CCM.0000000000005066

TABLE 2.

Plasma Administration, Adverse Events/Safety, Follow-Up, and Outcomes

Characteristics Convalescent Plasma, n = 59 Standard Plasma, n = 15 Wilcoxon Rank-Sum p or Hazard Ratio (95% CI)
Received any amount of assigned plasma, n (%)      58 (98)    14 (93)

Did not receive any plasma, n (%)     1 (2)      1 (7)

IgG antibody to severe acute respiratory syndrome coronavirus 2, reflectance light unit, median (IQR)
 IgG plasma bag number 1    285 (240–331)      7 (2–11)
 IgG plasma bag number 2    292 (250–335)      6 (3–14)
 IgM plasma bag number 1      75 (38–129)      5 (4–12)
 IgM plasma bag number 2      67 (51–122)      6 (5–11)

Infusion-related event, n (%)     1 (2)      0 (0)

Any SAE in the first 28 d, n (%)      16 (30)      4 (27)
 Any SAE in the first 24 hr     2 (4)      1 (7)
 Any SAE in days 2–7     8 (15)      2 (13)
 Any SAE in days 8–28      10 (19)      1 (7)

Lost to follow-up at study completion (90 ± 10 d), n (%)     0 (0)      0 (0)

Outcomes
 Primary outcome, ventilator-free days, median (IQR)      28 (2–28)    28 (0–28)     p = 0.86
  Ventilator-free days in patients who were intubated at baseline      16 (0–23)      0 (0–0)     p = 0.10
  Ventilator-free days in patients who were not intubated at baseline      28 (27.5–28)    28 (28)     p = 0.49
 Secondary outcomes, n (%)
  90-d all-cause mortality      16 (27)      5 (33)   0.74 (0.27–2.03)
   90-d mortality in patients who were intubated at baseline     5 (45)      3 (100)   0.05 (0.01–0.46)
   90-d mortality in patients who were not intubated at baseline      11 (23)      2 (17)   1.43 (0.32–6.46)
  28-d all-cause mortality      14 (24)      4 (27)   0.80 (0.26–2.44)
  World Health Organization ordinal scale 2 point change      12 (20)      3 (20)   0.75 (0.21–2.68)

IgG = immunoglobulin G, IgM = immunoglobulin M, IQR = interquartile range, SAE = serious adverse event.

Reflectance light units of antigen/antibody band in immunochromatographic test to severe acute respiratory syndrome coronavirus 2 (Fig. 1 for neutralizing antibody activity results).

SAE including death, grade 4 or greater organ failure, serious infusion reaction warranting termination of plasma infusion.

Dashes indicate no statistic for these variables.