Table. Participant Characteristics at Baseline.
Characteristic | Convalescent plasma (n = 1078)a | No convalescent plasma (n = 909)a |
---|---|---|
Age, median (IQR), y | 61 (52-69) | 61 (52-70) |
Sex | ||
Male | 727 (67.4) | 618 (68.0) |
Female | 351 (32.6) | 291 (32.0) |
Race and ethnicity, No./total (%)b | ||
Asian | 144/976 (14.8) | 133/832 (16.0) |
Black | 51/976 (5.2) | 38/832 (4.6) |
>1 race | 16/976 (1.6) | 8/832 (1.0) |
White | 731/976 (74.9) | 619/832 (74.4) |
Other | 34/976 (3.5) | 34/832 (4.1) |
Acute Physiology and Chronic Health Evaluation II score, median (IQR)c | (n = 1044); 13.0 (8.0-19.0) | (n = 888); 12.0 (8.0-19.0) |
Preexisting conditions, No./total (%) | ||
Diabetes | 339/1078 (31.4) | 268/907 (29.5) |
Respiratory disease | 245/1078 (22.7) | 216/907 (23.8) |
Kidney diseased | 107/1000 (10.7) | 83/837 (9.9) |
Severe cardiovascular diseasee | 96/1053 (9.1) | 67/890 (7.5) |
Immunosuppressive disease or therapyf | 67/1066 (6.3) | 60/907 (6.6) |
SARS-CoV-2, No./total (%) | ||
RNA detected at randomization via a respiratory sample (wild-type or Alpha variant)g | 676/845 (80.0) | 489/599 (81.6) |
Negative for antibody at baseline | 271/874 (31.0) | 149/558 (26.7) |
Time to enrollment, median (IQR), hh | ||
From hospital admissioni | 42.7 (23.6-78.6) | 41.7 (22.5-84.3) |
From ICU admission | 17.7 (10.2-23.5) | 17.2 (10.6-23.2) |
Use and type of acute respiratory supportj | ||
Noninvasive mechanical ventilation | 493 (45.7) | 407 (44.8) |
Invasive mechanical ventilation | 356 (33.0) | 289 (31.8) |
High-flow nasal cannula | 225 (20.9) | 211 (23.2) |
None or supplemental oxygen only | 2 (0.2) | 1 (0.1) |
Extracorporeal membrane oxygenation | 2 (0.2) | 1 (0.1) |
Use of vasopressor supportj | 207 (19.2) | 175 (19.3) |
Country of enrollment, No./total (%) | ||
UK | 1023/1078 (94.9) | 868/909 (95.5) |
Canada | 39/1078 (3.6) | 35/909 (3.9) |
USk | 12/1078 (1.1) | 0/1078 |
Australia | 4/1078 (0.4) | 6/909 (0.7) |
COVID-19 therapy use, No./total (%)l | ||
Glucocorticoids | 1014/1078 (94.1) | 845/909 (93.0) |
Remdesivir | 491/1078 (45.5) | 398/909 (43.8) |
Immunomodulators (tocilizumab or sarilumab) | 425/1078 (39.4) | 348/909 (38.3) |
No. (%) unless otherwise indicated; percentages may not sum to 100 because of rounding. Additional information appears in eTable 1 in Supplement 2.
Self-reported via fixed categories. Data collection was not approved in Asia, Canada, and continental Europe. “Other” includes “other ethnic group” and those who declined to respond or were not asked by registration personnel.
Measures the severity of illness based on age, medical history, and physiological variables. Scores range from 0 to 71; higher numbers represent greater risk of death. The median score of 12 is typical for patients with COVID-19 admitted to intensive care units (ICUs).
Determined from the most recent stable serum creatinine level prior to this hospital admission, except in patients who were receiving dialysis. Abnormal kidney function was defined as a creatinine level of 130 μmol/L or greater (≥1.5 mg/dL) for males or 100 μmol/L or greater (≥1.1 mg/dL) for females not previously receiving dialysis.
Defined as New York Heart Association class IV.
Recent chemotherapy, radiation, high-dose or long-term steroid treatment, or presence of immunosuppressive disease (eTable 2 in Supplement 2).
Polymerase chain reaction (PCR) test was positive between 24 hours before and after randomization. PCR test conducted either within the same hospital admission or prior to admission.
The time to receipt of convalescent plasma from enrollment and randomization was a median of 5.7 hours (IQR, 3.5-17.8 hours) in 1013 patients.
Includes time in the emergency department.
Required to have high-flow nasal cannula oxygenation, invasive or noninvasive mechanical ventilation, or vasopressor or inotropic infusion.
Unable to randomize participants to the no convalescent plasma group due to the Emergency Use Authorization program of the US Food and Drug Administration.
Received within 48 hours of randomization.