Table 1.
Baseline characteristics and concomitant treatments during hospitalization in the modified intention to treat population.
| Characteristics | Clq/HClq group (n = 53) | Control group (n = 52) |
|---|---|---|
| Age, mean (SD), years | 54.7 (12.1) | 52.8 (12.6) |
| Sex male, no. (%) | 36 (67.9) | 34 (65.4) |
| Body mass index, mean (SD) | 31.3 (5.7) | 30.8 (5.5) |
| Comorbidities, no. (%)a | ||
| Hypertension | 19 (35.8) | 21 (40.4) |
| Diabetes mellitus | 11 (20.8) | 16 (30.8) |
| Chronic lung diseaseb | 6 (11.3) | 3 (5.8) |
| Immunocompromised statec | 2 (3.8) | 4 (7,6) |
| Charlson score, median (IQR) | 0.5 (0–1) | 0.7 (0–1) |
| SpO2 < 94%, no. (%) | 51 (96.2) | 49 (94.2) |
| IMV at baseline, no. (%) | 9 (17) | 10 (19.2) |
| In ICU at baseline, no. (%) | 44 (83) | 41 (78.8) |
| Pulmonary ground-glass opacities in CT scan, no. (%) | 52 (98.1) | 49 (94.2) |
| Time from symptom onset to randomization, median (IQR), days | 8 (5.5–10) | 7 (5–10) |
| APACHE II score, median (IQR) | 9 (5.5–12) | 8 (5–12.8) |
| SOFA score, median (IQR) | 3.0 (2–4) | 2.5 (1–4) |
| KDIGO stage, no. (%) | ||
| 0 | 44 (83) | 40 (76.9) |
| 1 | 7 (13.2) | 9 (17.3) |
| 2 | 1 (1.9) | 2 (3.8) |
| 3 | 1 (1.9) | 1 (1.9) |
| Coagulopathy at baseline, no. (%) | 8 (15.1) | 9 (17.3) |
| Score on nine-point ordinal scale, no. (%)d | ||
| 3: hospitalized, but not requiring supplemental oxygen | 1 (1.9) | 0 (0) |
| 4: hospitalized and on oxygen by mask or nasal prongs | 43 (81.1) | 42 (80.8) |
| 5: hospitalized, on NIPPV, HFNC or support pressure MV in weaning mode | 0 (0) | 0 (0) |
| 6: hospitalized, intubated and on MV | 1 (1.9) | 3 (5.8) |
| 7: hospitalized on MV and additional organ support (hemodialysis and/or vasoactive drugs and/or ECMO) | 8 (15.1) | 7 (13.5) |
| Laboratory variables | ||
| Hemoglobin, mean (SD), g/dLe | 13.5 (1.6) | 13.9 (1.3) |
| White blood cell count, median (IQR), × 109/Le | 7.8 (6.1—10.8) | 7.4 (5.2—9) |
| Lymphocyte count, median (IQR), × 109/Le | 0.97 (0.66—1.40) | 0.87 (0.56—0.90) |
| Neutrophil/lymphocyte ratio, median (IQR)e | 6 (3.9—10.1) | 6.5 (4.0—9.7) |
| Platelet count, mean (SD), × 109/Le | 222.0 (79.5) | 217.2 (78.0) |
| Serum creatinine, median (IQR), mg/dL | 0.78 (0.65—1.02) | 0.78 (0.63—1.00) |
| CRP, median (IQR), mg/Lf | 101.8 (65.0—158.0) | 84 (41.5—151.0) |
| D-dimer, median (IQR), nmol/Lg | 893.8 (432—1645.8) | 821 (409 -1601.3) |
| Concomitant medications | ||
| Corticosteroids, no. (%) | 37 (69.8) | 39 (75) |
| Oseltamivir, no. (%) | 27 (50.9) | 27 (51.9) |
| Azithromycin, no. (%) | 51 (96.2) | 43 (82.7) |
SpO2 pulse oxygen saturation; ICU intensive care unit; MV mechanical ventilation; IMV invasive ventilation; CT computed tomography; APACHE II Acute Physiology and Chronic Health disease Classification System II; SOFA Sequential Organ Failure Assessment; KDIGO Kidney Disease: Improving Global Outcomes; HFNC high-flow nasal cannula; NIPPV noninvasive positive-pressure ventilation; ECMO extracorporeal membrane oxygenation; CRP C-reactive protein, SD standard deviation; IQR interquartile range; Clq chloroquine; HClq hydroxychloroquine.
aNo participants had any of the following comorbidities: chronic renal failure; peripheral vascular insufficiency; or heart, liver, rheumatic, or hematological disease.
bConsidering asthma or chronic obstructive pulmonary disease.
cConsidering cancer or human immunodeficiency virus infection.
dOnly hospitalized patients were eligible for the trial; therefore, patients who had scores of 0, 1, 2 or 8 on a nine-point ordinal scale were not eligible.
eOne missing data point in the Clq/HClq group.
fThree missing data points in the Clq/HClq group and one missing data point in the control group.
g27 missing data points in the Clq/HClq group and 25 in the control group.