TABLE 1.
Characteristics of the Patients at Baseline
| Characteristics | Convalescent Plasma, n = 59 | Standard Plasma, n = 15 |
|---|---|---|
| Age, mean (sd) | 67 (15.8) | 64 (17.4) |
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| Male sex, n (%) | 36 (61.0) | 8 (53.3) |
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| Race White, n (%) | 42 (71.2) | 8 (53.3) |
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| Body mass index, kg/m2, median (IQR) | 28.9 (24.0–33.6) | 27.8 (23.1–30.2) |
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| Diabetes, n (%) | 19 (32.2) | 6 (40.0) |
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| Hypertension, n (%) | 40 (67.8) | 11 (73.3) |
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| Chronic obstructive pulmonary disease, n (%) | 7 (11.9) | 2 (13.3) |
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| Chronic heart failure, n (%) | 11 (18.6) | 2 (13.3) |
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| Chronic renal insufficiency, n (%) | 7 (11.9) | 0 (0) |
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| Coronary artery disease, coronary artery bypass graft surgery, percutaneous coronary intervention, myocardial infarction, n (%) | 12 (20.3) | 3 (20.0) |
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| Cerebrovascular disease, n (%) | 9 (15.3) | 2 (13.3) |
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| Receiving immunosuppressant medication, n (%) | 4 (6.8) | 2 (13.3) |
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| Polymerase chain reaction+ documented COVID-19 infection, n (%) | 59 (100) | 15 (100) |
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| Days symptom start to randomization, median (IQR) | 9 (6–18) | 9 (6–15) |
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| Days admission to randomization, median (IQR) | 4 (2–10) | 4 (3–6) |
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| In ICU at randomization, n (%) | 17 (28.8) | 3 (20.0) |
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| Type of oxygen supplementation, n (%) | ||
| Nasal cannula or mask | 30 (50.8) | 4 (26.7) |
| High-flow nasal cannula or continuous positive airway pressure)/bilevel positive airway pressure | 3 (5.1) | 2 (13.3) |
| Intubated | 11 (18.6) | 3 (20.0) |
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| Any FDA COVID-19 sign or symptoms*, n (%) | 46 (78.0) | 13 (86.7) |
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| Any FDA severe COVID-19 sign/symptom, n (%) | 44 (74.6) | 13 (86.7) |
| Shortness of breath | 38 (64.4) | 7 (46.7) |
| Respiratory rate ≥ 30 | 14 (23.7) | 2 (13.3) |
| o2 saturation ≤ 93% | 32 (54.2) | 9 (60.0) |
| Pao2/Fio2 < 300 | 15 (25.4) | 3 (20.0) |
| Bilateral lung infiltrates | 39 (66.1) | 12 (80.0) |
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| Acute Physiology and Chronic Health Evaluation II score, mean (sd) | 23.4 (5.6) | 22.5 (6.6) |
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| Laboratory values, median (IQR) | ||
| Serum creatinine, mg/dL | 0.82 (0.64–1.11) | 0.64 (0.56–0.86) |
| d-dimer, ng/mL | 746 (407–1,524) | 424 (294–631) |
| C-reactive protein, mg/mL | 3.1 (0.9–9.3) | 1.9 (0.7–8.1) |
| Lymphocyte count, ×103/cmm | 0.64 (0.305–1.265) | 0.95 (0.49–1.1) |
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| Putative COVID-19 treatments during trial, n (%) | ||
| Glucocorticoids | 37 (62.7) | 8 (53.3) |
| Remdesivir | 16 (27.1) | 2 (13.3) |
| Hydroxychloroquine | 20 (33.9) | 3 (20.0) |
| Tocilizumab | 13 (22.0) | 3 (20.0) |
| Sarilumab | 1 (1.7) | 0 (0) |
COVID-19 = coronavirus disease 2019, FDA = U. S. Food and Drug Administration, IQR = interquartile range.