Table 1.
Baseline characteristics of patients and outcomes at the 28th day visit.
| Baseline characteristics | AllN = 249 | Delta-infected patients who received Casirivimab/Imdevimab N = 133 (53%) | Omicron-infected patients who received Sotrovimab N = 116 (47%) | p-value |
|---|---|---|---|---|
| Age (median, Q1-Q3) | 54 (43–67) | 54 (42–67) | 55 (44–68) | 0.56 |
| ≥65 years (%) | 76 (31) | 41 (31) | 35 (30) | |
| ≥80 years (%) | 20 (8) | 11 (8) | 9 (8) | |
| Male sex (%) | 126 (51) | 71 (53) | 55 (47) | 0.35 |
| BMI (median, Q1-Q3) | 21 (18–25) | 22 (18–25) | 21 (19–25) | 0.73 |
| Immunocompromised patients (%), including: | 191 (77) | 102 (77) | 89 (77) | 0.99 |
| Solid organ transplantation (%) | 77 (40) | 41 (40) | 36 (40) | 0.97 |
| Immunosuppressive therapy including rituximab (%) | 74 (39) | 42 (41) | 32 (36) | 0.46 |
| Ongoing chemotherapy for cancer or hematological malignancies (%) | 33 (17) | 15 (15) | 18 (20) | 0.31 |
| Corticosteroids >10 mg/day for > 2 weeks (%) | 25 (13) | 17 (17) | 8 (9) | 0.12 |
| Systemic lupus or vasculitis with immunosuppressive medications (%) | 11 (6) | 6 (6) | 5 (6) | 0.93 |
| Allogeneic hematopoietic stem cell transplantation (%) | 7 (4) | 2 (2) | 5 (6) | 0.25 |
| Kidney failure with GFR < 30 mL/min or dialysis (%) | 6 (3) | 6 (6) | – | – |
| Other immunosuppressive conditions (%) | 2 (1) | 1 (1) | 1 (1) | – |
| Other risk factors for severe COVID-19 (%) | 106 (43) | 48 (36) | 58 (50) | 0.03 |
| Diabetes (type 1 and type 2,%) | 34 (32) | 18 (38) | 16 (28) | 0.28 |
| Obesity (BMI>30,%) | 30 (28) | 17 (35) | 13 (22) | 0.14 |
| Chronic kidney disease (%) | 24 (23) | 9 (19) | 15 (26) | 0.38 |
| High blood pressure (%) | 24 (22) | 12 (25) | 12 (21) | 0.60 |
| COPD and chronic respiratory failure (%) | 7 (7) | 5 (12) | 2 (3) | 0.24 |
| Congestive heart failure (%) | 5 (5) | 2 (4) | 3 (5) | 0.99 |
| Vaccination status | 0.002 | |||
| Complete (≥ 3 doses) | 133 (66) | 56 (54) | 77 (77) | |
| Incomplete (≤ 2 doses) | 41 (20) | 30 (29) | 11 (11) | |
| Unvaccinated | 29 (14) | 17 (17) | 12 (12) | |
| Known serum IgG anti-Spike status (%) | 106 (43) | 67 (50) | 39 (35) | 0.01 |
| Negative | 57 (55) | 41 (62) | 16 (41) | 0.04 |
| Positive | 48 (45) | 25 (38) | 23 (59) | – |
| Median IgG anti-Spike level (BAU/mL, Q1-Q3) | 169 (79–824) | 148 (41–449) | 408 (95–3735) | 0.03 |
| Gene N Ct value at baseline – median (Q1-Q3) | 19 (15–25) | 17 (15–26) | 23 (18–25) | 0.43 |
| Outcome at day 28 visit | Delta-infected patients who received Casirivimab/Imdevimab N = 129 (97%) | Omicron-infected patients who received SotrovimabN = 63 (54%) | ||
| Changes in symptoms severity | ||||
| Worsening of symptoms (%) | 3 (3) | 3 (5) | ||
| No change in symptoms (%) | 3 (3) | 0 (0) | ||
| Improvement of symptoms (%) | 99 (94) | 55 (95) | ||
| COVID-19–related hospitalization (%) | 3 (2) | 2 (3) | ||
| Death from any cause (%) | 0 | 0 |
Missing values: BMI: n = 28 (25 in the Casirivimab - Imdevimab group and 3 in the Sotrovimab group); Median time between symptoms onset and administration of MAbs: n = 17 (10 in the Casirivimab - Imdevimab group and 7 in the Sotrovimab group); Vaccination status: n = 46 (30 in the Casirivimab - Imdevimab group and 16 in the Sotrovimab group); Results of the serum IgG anti-Spike status: n = 1 (in the Casirivimab - Imdevimab group); Gene N Ct value at baseline: n = 21 (14 in the Casirivimab - Imdevimab group and 7 in the Sotrovimab group); Median IgG anti-Spike: n = 14 (10 in the Casirivimab - Imdevimab group and 4 in the Sotrovimab group); Changes in symptoms severity at day 7: n = 13 (5 in the Casirivimab - Imdevimab group and 8 in the Sotrovimab group); Changes in symptoms severity at day 28: n = 29 (24 in the Casirivimab - Imdevimab group and 5 in the Sotrovimab group).