TABLE 2.
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.