Table 1.
Patient and treatment characteristics for the overall patient collective for both treatment arms combined and each separately
| Characteristic | All (n = 134) | Control (n = 66) | Plasma (n = 68) |
|---|---|---|---|
| General | |||
| Mean ± s.d. age (years) | 68.5 ± 11.3 | 69.7 ± 10.5 | 67.4 ± 12.1 |
| Sex | |||
| Male | 91 (67.9%) | 46 (69.7%) | 45 (66.2%) |
| Female | 43 (32.1%) | 20 (30.3%) | 23 (33.8%) |
| Ethnic origin | |||
| Asian | 1 (0.7%) | 1 (0.7%) | 0 (0%) |
| Caucasian/White | 130 (97.0%) | 64 (97.0%) | 66 (97.1%) |
| Hispanic | 2 (1.5%) | 0 (0%) | 2 (2.9%) |
| Other | 1 (0.7%) | 1 (1.5%) | 0 (0%) |
| Median (25th percentile, 75th percentile) time from symptom onset to randomization (d)a | 7.0 (4.0, 10.0) | 7.0 (4.0, 10.0) | 7.0 (5.0, 10.0) |
| Comorbidities | |||
| Chronic lung disease | 37 (27.6%) | 20 (30.3%) | 17 (25.0%) |
| Cardiovascular disease | 94 (70.1%) | 47 (71.2%) | 47 (69.1%) |
| Chronic liver disease | 15 (11.2%) | 11 (16.7%) | 4 (5.9%) |
| Rheumatic/immunologic disease | 16 (11.9%) | 8 (12.1%) | 8 (11.8%) |
| Organ transplant | 17 (12.7%) | 10 (15.2%) | 7 (10.3%) |
| Diabetes | 34 (25.4%) | 19 (28.8%) | 15 (22.1%) |
| Chronic kidney disease | 35 (26.1%) | 21 (31.8%) | 14 (20.6%) |
| Chronic kidney disease with hemodialysis | 13 (9.7%) | 9 (13.6%) | 4 (5.9%) |
| Median (25th percentile, 75th percentile) clinical frailty scale scorea | 3.0 (2.0, 4.0) | 3.0 (2.0, 4.0) | 3.0 (2.0, 4.0) |
| WHO performance statusa | |||
| ECOG = 0 | 3 (2.3%) | 1 (1.5%) | 2 (3.0%) |
| ECOG = 1 | 27 (20.5%) | 12 (18.5%) | 15 (22.4%) |
| ECOG = 2 | 51 (38.6%) | 29 (44.6%) | 22 (32.8%) |
| ECOG = 3 | 35 (26.5%) | 16 (24.6%) | 19 (28.4%) |
| ECOG = 4 | 16 (12.1%) | 7 (10.8%) | 9 (13.4%) |
| Cancerb | |||
| All entities | 56 (41.8%) | 28 (42.4%) | 28 (41.2%) |
| B cell non-Hodgkin lymphoma/chronic lymphocytic leukemia | 18 (32.1%) | 7 (25.0%) | 11 (39.3%) |
| Acute myeloid leukemia/myelodysplastic syndromes | 12 (21.4%) | 8 (28.6%) | 4 (14.3%) |
| Myeloma | 11 (19.6%) | 6 (21.4%) | 5 (17.9%) |
| B cell acute lymphoblastic leukemia | 2 (3.6%) | 0 (0%) | 2 (7.1%) |
| Hodgkin lymphoma | 2 (3.6%) | 1 (3.6%) | 1 (3.6%) |
| Chronic myeloid leukemia | 1 (1.8%) | 1 (3.6%) | 0 (0%) |
| T cell non-Hodgkin lymphoma | 1 (1.8%) | 1 (3.6%) | 0 (0%) |
| Solid tumor | 9 (16.1%) | 4 (14.3%) | 5 (17.9%) |
| SARS-CoV-2 baseline | |||
| Median (25th percentile, 75th percentile) percentage inhibition (as measured by NeutraLISA)a | 9.3 (4.8, 26.2) | 8.5 (4.0, 20.3) | 10.2 (5.5, 28.8) |
| Mean ± s.d. Ct value on day of randomization/day 1a | 23.6 ± 5.6 | 23.3 ± 5.2 | 23.9 ± 6.1 |
| Study assessments | |||
| 7POS at randomization | |||
| 7POS = 3 | 26 (19.4%) | 12 (18.2%) | 14 (20.6%) |
| 7POS = 4 | 80 (59.7%) | 40 (60.6%) | 40 (58.8%) |
| 7POS = 5 | 28 (20.9%) | 14 (21.2%) | 14 (20.6%) |
| Laboratory | |||
| Median (25th percentile, 75th percentile) WBC count (109 cells per liter) | 5.7 (3.7, 8.6) | 6.1 (4.0, 8.9) | 5.4 (3.6, 7.5) |
| Median (25th percentile, 75th percentile) lymphocytes (109 cells per liter)a | 0.6 (0.3, 0.9) | 0.5 (0.3, 0.9) | 0.6 (0.3, 0.8) |
| Median (25th percentile, 75th percentile) CRP (mg l−1)a | 80.8 (42.5, 147.2) | 85.0 (48.2, 138.7) | 72.7 (39.8, 157.6) |
| Median (25th percentile, 75th percentile) LDH (U l−1)a | 359.0 (277.0, 473.1) | 368.5 (278.0, 497.0) | 354.0 (277.0, 457.0) |
| Median (25th percentile, 75th percentile) d-dimer (mg l−1)a | 1.3 (0.7, 2.1) | 1.4 (0.7, 2.4) | 1.1 (0.7, 1.6) |
| Median (25th percentile, 75th percentile) troponin (pg ml−1)a | 17.2 (11.4, 32.0) | 23.0 (10.5, 48.6) | 15.9 (11.4, 25.3) |
| Treatment (including crossover day 10) | |||
| Plasma received | |||
| Convalescent plasma | 67 | 6 | 61 |
| Convalescent plus vaccinated plasma | 7 | 3 | 4 |
| Vaccinated plasma only | 4 | 1 | 3 |
| Other COVID-19 medication | |||
| Anti-inflammatory | 49 (36.6%) | 22 (33.3%) | 27 (39.7%) |
| Small-molecule antiviral | 11 (8.2%) | 3 (4.5%) | 8 (11.8%) |
| Biologic antiviral | 3 (2.2%) | 1 (1.5%) | 2 (2.9%) |
| Antibiotics | 6 (4.5%) | 3 (4.5%) | 3 (4.4%) |
| Anticoagulants | 2 (1.5%) | 2 (3.0%) | 0 (0%) |
| Other concomitant medication | 9 (6.7%) | 5 (7.6%) | 4 (5.9%) |
aNumbers were as follows (n ≠ 134): n = 116 for time from symptom onset to randomization, n = 127 for clinical frailty scale score, n = 132 for World Health Organisation (WHO) performance status, n = 119 for percentage inhibition (as measured by NeutraLISA), n = 119 for Ct values, n = 117 for lymphocytes, n = 132 for C-reactive protein (CRP), n = 127 for lactate dehydrogenase (LDH), n = 125 for d-dimer and n = 122 for troponin.
bPre-existing or concurrent hematological malignancy and/or active cancer therapy (including chemotherapy, radiotherapy or surgery) within the last 24 months or less.
EGOG, Eastern Cooperative Oncology Group; WBC, white blood cell.