Table 1.
Characteristics and main outcomes
| Hydroxychloroquine/azithromycin (n = 17) | Lopinavir/ritonavir (n = 13) | Controls (n = 15) | p value | |
|---|---|---|---|---|
| Age (years, mean ± SD) | 60 ± 17 | 62 ± 13 | 60 ± 16 | 0.94 |
| Male gender | 15 (88%) | 9 (69%) | 11 (73%) | 0.41 |
| Hypertension | 8 (47%) | 8 (62%) | 5 (33%) | 0.33 |
| Diabetes mellitus | 6 (35%) | 5 (38%) | 2 (13%) | 0.26 |
| Chronic cardiac disease | 2 (12%) | 5 (38%) | 0 | 0.02 |
| Chronic respiratory disease | 2 (12%) | 2 (15%) | 1 (7%) | 0.76 |
| Obesity | 6 (35%) | 6 (46%) | 9 (60%) | 0.38 |
| Immunosuppressive therapy | 1 (6%) | 1 (8%) | 0 (0%) | 0.58 |
| Time from COVID-19 symptoms onset to treatment (days, median, IQR) | 7 (4–11) | 5 (2–6) | 8 (4.5–10.5)a | 0.06 |
| Time from COVID-19 treatment to ARDS (days, median, IQR) | 1 (0–4) | 0 (0–0) | 0 (0–0)a | 0.02 |
| SAPS 2 score (mean ± SD) at ICU admission | 30 ± 7 | 33 ± 11 | 49 ± 14 | < 0.01 |
| SOFA score at ICU admission (median, 1st–3rd Quartile) | 4 (3–6) | 6 (3–7) | 6 (4–9.5) | 0.27 |
| PaO2/FiO2 ratio at ICU admission (mean ± SD) | 141 ± 48 | 159 ± 37 | 129 ± 50 | 0.21 |
| Vt at ICU admission (ml, mean ± SD) | 388 ± 64 | 392 ± 76 | 415 ± 42 | 0.59 |
| PEEP at ICU admission, (cm H2O, median, 1st–3rd quartile) | 12 ± 2 | 13 ± 2 | 13 ± 3 | 0.8 |
| SARS-CoV-2 PCR CT values at diagnosis (mean ± SD)b | 28 ± 5 | 25 ± 9 | – | 0.88 |
| SARS-CoV-2 PCR CT values at day 6 from treatment (mean ± SD)b | 29 ± 5 | 33 ± 1 | – | 0.01 |
| Negative SARS-CoV-2 PCR at day 6 from treatment | 3 (18%) | 5 (38%) | 2c (20%) | 0.39 |
| Negative SARS-CoV-2-PCR at day 6 from ARDS | 2 (12%) | 5 (38%) | 2 (13%) | 0.14 |
| PaO2/FiO2 ratio at day 6 from ARDS onset (mean ± SD) | 160 ± 59 | 183 ± 64 | 150 ± 46 | 0.69 |
| SOFA score at day 6 from treatment (median, IQR) | 4.5 (3–6) | 6 (4–6) | 6 (5–7) | 0.9 |
| SOFA score at day 6 from ARDS onset (median, IQR) | 4.5 (3–7) | 6 (4–6) | 6 (5–7) | 0.9 |
| Alive at day 6 from ARDS | 15 (88%) | 13 (100%) | 15 (100%) | |
| Invasive mechanical ventilationd | 16 (94%) | 12 (92%) | 15 (100%) | |
| Neuromuscular blockersd | 16 (94%) | 11 (85%) | 14 (93%) | |
| Prone positioningd | 14 (82%) | 8 (62%) | 12 (80%) | |
| Inhaled nitric oxided | 4 (24%) | 3 (23%) | 4 (27%) | |
| ECMOd | 2 (12%) | 1 (8%) | 1 (7%) |
ARDS acute respiratory distress syndrome, CT cycle threshold, ECMO extracorporeal membrane oxygenation, ICU intensive care unit, IQR interquartile range, PEEP positive end-expiratory pressure, SAPS 2 Simplified Acute Physiology Score, SOFA Sepsis-related Organ Failure Assessment score, Vt tidal volume
aAntibiotics (no anti-viral treatment and no azithromycin in this group)
bWhen available, in positive patients
cOnly 10 patients assessed
dDuring the first 6 days of ARDS
- Data not available