Table 1.
Baseline characteristics of the intention to treat population.
| ATV (n = 63) | DCV (n = 64) | SOF + DCV (n = 67) | Placebo (n = 56) | Total (n = 250) | |
|---|---|---|---|---|---|
| Age, mean [SD] | 54.5 [14.3] | 52.3 [14.4] | 55.9 [14.1] | 53.7 [13.4] | 54.2 [14.0] |
| Sex (male), n (%) | 44 (70%) | 41 (64%) | 44 (66%) | 40 (71%) | 169 (68%) |
| Positive COVID-19 test | |||||
| SARS-Cov 2 Antigen Test | 16 (25%) | 14 (22%) | 15 (22%) | 14 (25%) | 59 (24%) |
| POCT-PCR | 1 (2%) | 0 (0%) | 1 (1.5%) | 0 (0%) | 2 (1%) |
| RT-PCR | 46 (73%) | 50 (78%) | 51 (76%) | 42 (75%) | 189 (76%) |
| SARS-CoV-2 sequenced genomes | 46 (73%) | 44 (69%) | 47 (70%) | 43 (77%) | 180 (72%) |
| SARS-CoV-2 variants | |||||
| Alpha | 0 (0%) | 1 (2.0%) | 0 (0%) | 0 (0%) | 1 (0.6%) |
| Gamma | 42 (91%) | 40 (91%) | 43 (91.5%) | 42 (98%) | 167 (93%) |
| Delta | 1 (2%) | 0 (0%) | 1 (2%) | 0 (0%) | 2 (1%) |
| Non-VoC | 3 (6.5%) | 3 (7%) | 3 (6%) | 1 (2%) | 10 (6%) |
| Comorbities | |||||
| Hypertension | 30 (48%) | 25 (39%) | 30 (45%) | 19 (34%) | 104 (41.6%) |
| Diabetes | 16 (25%) | 12 (19%) | 19 (28%) | 10 (18%) | 57 (23%) |
| Current smoker | 1 (2%) | 0 (0%) | 1 (1.5%) | 0 (0%) | 2/ (1%) |
| Former smoker | 6 (9.5%) | 5 (8%) | 2 (3%) | 3 (5%) | 16 (6%) |
| Obesity | 14 (22%) | 16 (25%) | 17 (25%) | 12 (21%) | 59 (24%) |
| Cancer | 2 (3%) | 1 (2%) | 0 (0%) | 3 (5%) | 6 (2%) |
| Heart failure | 2 (3%) | 0 (0%) | 0 (0%) | 0 (0%) | 2 (1%) |
| COPD | 2 (3%) | 0 (0%) | 1 (1.5%) | 2 (4%) | 5 (2%) |
| Chronic renal disease | 2 (3%) | 1 (2%) | 0 (0%) | 0 (0%) | 3 (1%) |
| Neuromuscular disease | 1 (2%) | 4 (6%) | 1 (1.5%) | 1 (2%) | 7 (3%) |
| Other | 1 (2%) | 1 (2%) | 1 (1.5%) | 2 (4%) | 5 (2%) |
| Baseline medications | |||||
| Corticosteroids | 55 (87%) | 53 (83%) | 54 (81%) | 45 (80%) | 207 (83%) |
| Statins | 4 (6%) | 3 (5%) | 5 (7.5%) | 2 (4%) | 14 (6%) |
| Antiarrhythmic drugs | 0 (0%) | 0 (0%) | 0/ (0%) | 1 (2%) | 1 (0.4%) |
| Anticonvulsants | 0 (0%) | 1 (2%) | 0 (0%) | 2 (4%) | 3 (1%) |
| NOAC | 2 (33%) | 1 (2%) | 0 (0%) | 1 (2%) | 4 (2%) |
| Therapeutic Dose Heparin | 17 (27%) | 15 (23%) | 22 (33%) | 21 (35.5%) | 75 (30%) |
| Tocilizumab | 0 (0%) | 0 (0%) | 1 (1.5%) | 1 (2%) | 2 (1%) |
| Antibiotics | |||||
| Ceftriaxone | 26 (41.3%) | 32 (50.0%) | 32 (47.8%) | 25 (45%) | 115 (46.0%) |
| Ceftaroline | 0 (0.0%) | 0 (0.0%) | 2 (3%) | 1 (2%) | 3 (1%) |
| Piperaciline/Tazobactan | 1 (2%) | 0 (0.0%) | 1 (1.5%) | 1 (3%) | 3 (1%) |
| Quinolone | 1 (2%) | 1 (2%) | 1 (1.5%) | 0 (0.0%) | 3 (1%) |
| Clinical data | |||||
| Systolic Blood Pressure, mmHg, mean ± [SD] | 125.8 [15.0] | 125.7 [18.1] | 124.1 [14.9] | 122.2 [14.3] | 124.5 [15.6] |
| Diastolic Blood Pressure, mmHg, mean ± [SD] | 77.8 [10.0] | 76.7 [11.3] | 75.2 [8.6] | 74.7 [8.9] | 76.1 [9.8] |
| Heart Rate, bpm, mean [SD] | 84.9 [13.7] | 85.4 [12.8] | 84.0 [15.7] | 82.2 [18.3] | 84.2 [15.1] |
| Respiratory rate, bpm, mean [SD] | 22.3 [5.9] | 20.4 [3.7] | 21.6 [4.1] | 20.9 [4.3] (n = 56) | 21.3 [4.6] |
| Peripheral saturation O2, %, mean [SD] | 93.6 [2.3] | 93.9 [2.3] | 93.6 [2.7] | 93.3 [3.7] (n = 56) | 93.6 [2.8] |
| Supplemental oxygen at randomization | |||||
| Supplemental oxygen at day 1 | 56 (90%) | 52 (81%) | 49 (73%) | 41 (73%) | 198 (79%) |
| None | 6 (9.5%) | 6 (9%) | 15 (22%) | 9 (16%) | 36 (14%) |
| Oxygen catheter | 34 (54%) | 44 (69%) | 24 (36%) | 29 (52%) | 131 (52%) |
| Venturi mask | 9 (14%) | 7/(11%) | 14 (21%) | 5 (9%) | 35 (14%) |
| NIV | 10 (16%) | 5/(8%) | 6 (9%) | 6 (11%) | 27 (11%) |
| HFNC | 4 (6%) | 2 (3%) | 8 (12%) | 6 (11%) | 20 (8%) |
| Mechanical ventilation | 0 (0%) | 0 (0%) | 0 (0%) | 1 (2%) | 1 (0.4%) |
| Laboratorial | |||||
| Creatinine, mg/dL, median [quartiles] | 0.9 [0.7; 1.1] (n = 58)a | 0.9 [0.8; 1.2] (n = 57)a | 1.0 [0.7; 1.1] (n = 62)a | 0.9 [0.8; 1.1] (n = 53)a | 0.9 [0.8; 1.1] (n = 230)a |
| Bilirrubin, mg/dL, median [quartiles] | 0.4 [0.3; 0.6] | 0.4 [0.3; 0.6] | 0.4 [0.3; 0.5] | 0.4 [0.3; 0.6] | 0.4 [0.3; 0.6] |
| Urea, mg/dL, median [quartiles] | 33 [25; 49] (n = 55)a | 35 [28; 49] (n = 55)a | 35 [29; 46] (n = 60)a | 33 [26; 45] (n = 50)a | 34 [27; 46] (n = 220)a |
| ALT, IU/L, median [quartiles] | 46 [32; 59] (n = 62)a | 44 [27; 65] | 38 [30; 51] (n = 66)a | 38 [30; 63] | 42 [30; 59] (n = 248)a |
| AST, IU/L, median [quartiles] | 36 [25; 58] (n = 62)a | 40 [23; 62] | 32 [21; 54] (n = 66) | 33 [25; 55] | 35 [23; 57] (n = 248)a |
| Hemoglobin, g/dL, mean [SD] | 14 [13; 15] (n = 61)a | 14 [12; 14] (n = 63)a | 14 [12; 14] (n = 66)a | 14 [13; 15] (n = 55)a | 14 [13; 15] (n = 245)a |
| Leukocyte, 103/mL, median [quartiles] | 7.5 [5.7; 10.6] (n = 61)a | 6.9 [5.2; 10.3] (n = 63)a | 7.4 [5.9; 9.5] (n = 66)a | 7.0 [5.2; 9.7] (n = 55)a | 7.1 [5.5; 10.0] (n = 245)a |
| Platelets, 10³/mm³, median [quartiles] | 190 [153; 234] (n = 61)a | 190 [158; 223] (n = 63)a | 184 [143; 229] (n = 66)a | 192 [153; 233] (n = 55)a | 190 [151; 231] (n = 245)a |
| Lymphocyte, 10³/mL, median [IQR] | 0.8 [0.6; 1.1] (n = 61)a | 0.9 [0.7; 1.2] (n = 63)a | 0.8 [0.5; 1.2] (n = 66)a | 0.9 [0.7; 1.2] (n = 55)a | 0.9 [0.6; 1.2] (n = 245)a |
| Days from symptoms onset to randomization, median [quartiles] | 7.0 [6.0; 8.0] | 7.0 [6.0; 8.0] | 7.0 [6.0; 8.0] | 7.0 [6.0; 8.0] | 7.0 [6.0; 8.0] |
| Days from admission to randomization, median [quartiles] | 1.0 [0.0; 1.0] | 1.0 [0.0; 2.0] | 1.0 [0.0; 2.0] | 1.0 [0.0; 1.0] | 1.0 [0.0; 2.0] |
Data are n (%), mean [SD], median [IQR], n/N (%).
Percentages may not total 100 because of rounding.
AIDS = Acquired Immuno Deficiency Syndrome, ALT = Alanine Transaminase, AST = Aspartate Transaminase, ATV = Atazanavir, COPD = Chronic Obstructive Pulmonary Disease, DCV = Daclatasvir, HFNC = High Flow Nasal Cannula, NIV = Non Invasive Ventilation, NOAC = New Oral Anticoagulants, POCT-PCR = Point of Care Test Polymerase Chain Reaction, RT-PCR = Real Time Polymerase Chain Reaction, SOF + DCV = Sofosbuvir + Daclatasvir.
a
Data were complete except where identified in the table.