Table 2.
Virological and Clinical Outcomes Grouped by Baseline Disease Severity Strata
| Virological and Clinical Outcomes | Severe (n = 352) |
Critical Without IMV (n = 414) |
Critical With IMV (n = 334) |
MSOD (n = 262) |
|---|---|---|---|---|
| Baseline Virology | ||||
| Log10 copies/mL (IQR) | 3.75 (2.55–5.11) | 3.72 (2.55–5.09) | 4.58 (3.33–5.97) | 5.01 (3.76–6.17) |
| Above ULOQa | 8 (2.3) | 4 (1.0) | 15 (4.5) | 15 (5.7) |
| Below LLOQb | 47 (13.4) | 41 (9.9) | 24 (7.2) | 13 (5.0) |
| Not detected | 60 (17.0) | 91 (22.0) | 35 (10.5) | 22 (8.4) |
| Baseline SARS-COV-2 Serology (N = 384) | ||||
| Positive N/n (%) | 88/100 (88.0) | 103/109 (94.5) | 70/77 (90.9) | 89/98 (90.8) |
| Serology index | 66 (8–153) | 90 (20–170) | 86 (24–160) | 68 (18–138) |
| Baseline Oxygen Device | ||||
| Nonec | 4 (1.6) | 2 (0.5) | – | 1 (0.4) |
| Nasal cannula | 265 (75.3) | 36 (8.7) | – | 5 (1.9) |
| Simple face mask | 18 (5.1) | 13 (3.1) | – | 0 (0) |
| Non-rebreather facemask | 45 (12.8) | 170 (41.1) | – | 1 (0.4) |
| High-flow nasal cannula | 11 (3.1) | 160 (38.6) | – | 2 (0.8) |
| Noninvasive ventilation | 1 (0.3) | 29 (7.0) | – | 2 (0.8) |
| IMV | 7 (2.0) | – | 334 (100) | 229 (87.4) |
| Extracorporeal life support | 1 (0.3) | 4 (1.0) | – | 22 (8.4) |
| Clinical Outcomes | ||||
| All-cause mortality at day 60 | 39 (11.1) | 118 (28.5) | 135 (40.4) | 107 (40.8) |
| Clinical status improvement (≥1 point) at day 29 | 294 (83.5) | 261 (63.0) | 166 (49.7) | 118 (45.0) |
| Improvement in oxygenation at day 29 | 219 (62.2) | 263 (63.5) | 181 (54.2) | 139 (53.1) |
| Hospital discharge at day 29 | 291 (82.7) | 246 (59.4) | 121 (36.2) | 71 (27.1) |
| Symptom Duration (Days Post randomization) | ||||
| Fever (IQR) | 1 (1–2) | 1 (1–3) | 5 (2–10) | 5 (2–11) |
| Tachypnoea (IQR) | 2 (1–5) | 3 (1–8) | 7 (3–12) | 10 (4–16) |
| Hypoxemia (IQR) | 6 (4–10) | 11 (7–20) | 21 (13–30) | 27 (15–35) |
| Supplemental oxygen (IQR) | 6 (3–9) | 11 (7–20) | 20 (13–29) | 26 (14–34) |
Abbreviations: IMV, invasive mechanical ventilation; IQR, interquartile range; LLOQ, lower limit of quantification; MSOD, multisystem organ dysfunction; SARS-COV-2, severe acute respiratory syndrome coronavirus 2; ULOQ, upper limit of quantification.
NOTES: Data are presented as n (%) or median (Q1–Q3), except for serology index (SI), which is median (range). For longitudinal clinical outcomes, all-cause mortality was assessed at day 60, and clinical status improvement, improvement in oxygenation, and hospital discharge were assessed at day 29. For symptom duration, the data shown are for survivors only. Serology index values ≥1.1 were considered positive, SI values ≤0.8 were considered negative, SI values of 0.9 and 1.0 were considered borderline.
aULOQ corresponds to 7.1 × 107 copies/mL or 7.85 log10 copies/mL.
bLLOQ corresponds to 714 copies/mL or 1.85 log10 copies/mL.
cAll but 1 subject who enrolled into the study without supplemental oxygen requirements at randomization but who received supplemental oxygen by day 1 (baseline).