Table 1. Patient Characteristics at Baseline in the TXA-127 Trial and in the TRV-027 Trial.
| TXA-127 trial | TRV-027 trial | |||
|---|---|---|---|---|
| TXA-127 (n = 170) |
Placebo (n = 173) |
TRV-027 (n = 145) |
Placebo (n = 145) |
|
| Demographics, No. (%) | ||||
| Age group, y | ||||
| 18-30 | 11 (6.5) | 7 (4.1) | 5 (3.5) | 7 (4.8) |
| 31-64 | 106 (62.4) | 120 (69.4) | 100 (69.0) | 99 (68.3) |
| ≥65 | 53 (31.2) | 46 (26.6) | 40 (27.6) | 39 (26.9) |
| Sex assigned at birth | ||||
| Female | 67 (39.4) | 76 (43.9) | 53 (36.6) | 69 (47.6) |
| Male | 103 (60.6) | 97 (56.1) | 92 (63.4) | 76 (52.4) |
| Racea | ||||
| Asian | 3 (1.8) | 4 (2.3) | 2 (1.4) | 3 (2.1) |
| Black | 29 (17.1) | 29 (16.8) | 25 (17.2) | 21 (14.5) |
| Native American or Alaska Native | 5 (2.9) | 1 (0.6) | 2 (1.4) | 1 (0.7) |
| Native Hawaiian or Other Pacific Islander | 0 | 1 (0.6) | 0 | 0 |
| White | 112 (65.9) | 113 (65.3) | 99 (68.3) | 96 (66.2) |
| Other or prefer not to answer | 21 (12.4) | 25 (14.5) | 17 (11.7) | 24 (16.6) |
| Ethnicitya | ||||
| Hispanic | 26 (15.3) | 26 (15.0) | 24 (16.6) | 23 (15.9) |
| Not Hispanic | 136 (80.0) | 138 (79.8) | 111 (76.6) | 114 (78.6) |
| Other or prefer not to answer | 8 (4.7) | 9 (5.2) | 10 (6.9) | 8 (5.5) |
| Medical history, No. (%) b | ||||
| Obesity (BMI ≥30c) | 107 (62.9) | 109 (63.0) | 91 (62.8) | 90 (62.1) |
| Hypertension | 85 (50.0) | 91 (52.6) | 68 (46.9) | 69 (47.6) |
| Diabetes (with or without end-organ damage) | 47 (27.6) | 56 (32.4) | 39 (26.9) | 40 (27.6) |
| Chronic kidney disease (not undergoing kidney replacement therapy) | 22 (12.9) | 11 (6.4) | 13 (9.0) | 12 (8.3) |
| Chronic heart failure | 15 (8.8) | 10 (5.8) | 13 (9.0) | 7 (4.8) |
| Active cancer | 13 (7.6) | 14 (8.1) | 10 (6.9) | 9 (6.2) |
| Chronic obstructive pulmonary disease | 13 (7.6) | 32 (18.5) | 25 (17.2) | 25 (17.2) |
| Supplemental oxygen use prior to COVID-19 | 6 (3.5) | 7 (4.1) | 6 (4.1) | 5 (3.5) |
| Dementia | 5 (2.9) | 5 (2.9) | 1 (0.7) | 5 (3.5) |
| Cirrhosis | 3 (1.8) | 4 (2.3) | 5 (3.4) | 2 (1.4) |
| Medication use before COVID-19 | ||||
| Angiotensin-converting enzyme inhibitor | 7 (4.1) | 9 (5.2) | 7 (4.8) | 9 (6.2) |
| Angiotensin receptor blocker | 11 (6.5) | 11 (6.4) | 0 | 0 |
| COVID-19 characteristics | ||||
| Predominant SARS-CoV-2 variant in US, No. (%)b | ||||
| Delta (prior to and including Dec 26, 2021) | 108 (63.5) | 98 (56.6) | 103 (71.0) | 89 (61.4) |
| Omicron (after Dec 26, 2021) | 62 (36.5) | 75 (43.4) | 42 (29.0) | 56 (38.6) |
| Receipt of ≥1 COVID-19 vaccine dose, No. (%) | 53 (31.2) | 57 (32.9) | 41 (28.3) | 49 (33.8) |
| WHO COVID-19 clinical progression scale, No. (%)d | ||||
| Level 4: hospitalized and receiving supplemental oxygen by nasal prongs or mask | 100 (58.8) | 118 (68.2) | 84 (57.9) | 98 (67.6) |
| Level 5: hospitalized and receiving high-flow nasal oxygen or noninvasive ventilation | 54 (31.8) | 46 (26.6) | 48 (33.1) | 40 (27.6) |
| Level 6 or 7: hospitalized and receiving invasive mechanical ventilation alone or with other organ support | 16 (9.4) | 9 (5.2) | 13 (9.0) | 7 (4.8) |
| Time from hospital admission to randomization, median (IQR), d | 1 (1-2) | 1 (1-2) | 1 (1-2) | 1 (1-2) |
| Vasopressor use, No. (%)e | 13 (7.7) | 10 (5.8) | 12 (8.3) | 8 (5.5) |
| Acute in-hospital treatments for COVID-19 prior to randomization, No. (%)f | ||||
| Corticosteroids | 149 (87.6) | 136 (78.6) | 113 (77.9) | 112 (77.2) |
| Anticoagulantsg | 129 (75.9) | 129 (74.6) | 102 (70.3) | 104 (71.7) |
| Remdesivir | 120 (70.6) | 121 (69.9) | 95 (65.5) | 95 (65.5) |
| Baricitinib | 25 (14.7) | 22 (12.7) | 22 (15.2) | 18 (12.4) |
| Tocilizumab | 0 | 1 (0.6) | 0 | 1 (0.7) |
Abbreviations: BMI, body mass index; WHO, World Health Organization.
Self-reported using mutually exclusive categories.
Data were obtained from the medical record for each patient.
Calculated as weight in kilograms divided by height in meters squared.
Assessed at randomization. Eight-level ordinal scale representing the worst clinical status on a given day. Level 1 was defined as ambulatory and not hospitalized, no limitation of activities; level 2, ambulatory and not hospitalized with limitation of activities or receiving home oxygen therapy; level 3, hospitalized with mild disease, not receiving oxygen therapy; level 4, hospitalized with mild disease and receiving oxygen by mask or nasal prongs; level 5, hospitalized with severe disease and receiving noninvasive ventilation or high-flow oxygen; level 6, hospitalized with severe disease and receiving invasive mechanical ventilation; level 7, hospitalized with severe disease and receiving invasive mechanical ventilation plus additional organ support with vasopressors, kidney replacement therapy, or extracorporeal membrane oxygenation; and level 8, dead.
Prior to or on the day of randomization and included use of any vasopressors or inotropes (eg, dobutamine, dopamine, epinephrine, milrinone, norepinephrine, phenylephrine, and vasopressin).
Additional baseline patient characteristics and usual care in-hospital medications before randomization appear in eTables 7-8 in Supplement 1.
Collected as part of the medical history questionnaire and did not distinguish specific medications or doses.