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. 2021 Sep 29;70(10-12):1233–1246. doi: 10.1007/s00011-021-01507-5

Table 2.

Efficacy of levilimab in severely ill COVID-19 patients not requiring mechanical ventilation (main secondary efficacy endpoints)

Parameter Groups “as randomized” Groups “as treated”
LVL
(n = 103)
n (%)		 Placebo
(n = 103)
n (%)		 P value LVL
(n = 90)		 Placebo + LVL
(n = 42)		 LVL + LVL
(n = 13)		 Placebo
(n = 61)
Patients with sustained clinical improvement, n (%)
 Day 7 6 (5.8) 6 (5.8) 1.0000a 6 (6.7) 1 (2.4) 0 6 (9.9)
 Day 14 65 (63.1) 44 (42.7) .0017b 65 (72.2) 19 (45.2) 7 (53.9) 44 (72.1)
 Day 21 79 (76.7) 49 (47.6)  < .0001a 79 (87.8) 31 (73.8) 8 (61.5) 49 (80.3)
 Day 28 87 (84.5) 57 (55.3)  < .0001a 87 (96.7) 38 (90.5) 10 (76.9) 57 (93.4)
 Day 30 87 (84.5) 57 (55.3)  < .0001a 87 (96.7) 38 (90.5) 10 (76.9) 57 (93.4)
Patients transferred to the ICU, n (%) 3 (2.9) 10 (9.7) .0449a 2 (2.2) 9 (21.4) 2 (15.4) 3 (4.9)
Duration of fever, days after IP administration
 Median [IQR] 1 [1–3] 2 [1–3] .1065c 1 [1, 2] 2 [1–3] 1[1–3] 1 [1, 2]
Duration of hospital stay, days after IP administration
 Median [IQR] 11 [8–16] 11 [7–18] .4852c 10 [7.5–15.5] 14 [10–19] 12.5 [8–21] 9 [7–13]
ESR, mm/h
 Day 3
  Median [IQR] 30 [18–44.5] 38 [23–56] .0035c 29.5 [18–43.5] 45.5 [32.5–57] 30.5 [19.5–53.5] 35.5 [21–54]
 Day 5
  Median [IQR] 25 [15–41] 40 [24–55] .0002c 24 [15–42] 42 [27–57] 29 [16–38] 31 [21–53]
 Day 7
  Median [IQR] 23.0 [15–36] 31.0 [21–45] .0009c 23 [15–36.5] 34 [21–43] 27 [14–36] 30.5 [20–49]
CRP, mg/L
 Day 3
  Median [IQR] 14.6 [5.1–29.8] 31.7 [12–62.6]  < .0001c 12.9 [4.9–28.6] 50.8 [30–108] 28 [8.9–61] 22.4 [6–47.4]
 Day 5
  Median [IQR] 5.3 [1.5–15] 17.7 [6.9–44]  < .0001c 5 [1.5–12.1] 22.2 [10.5–57] 8.4 [2.8–23] 14.5 [5.5–27.9]
 Day 7
  Median [IQR] 3.9 [1.3–8.4] 9.2 [4.1–19]  < .0001c 3.8 [1.3–8.4] 9.7 [4.7–19] 4.6 [2.2–24] 8.5 [3.8–18.2]
IL-6, pg/ml
 Day 3
  Median [IQR] 65.9 [16.5–201] 16.4 [3.9–80.4] .0017c 56.6 [14.8–144] 51.7 [14–163.8] 205.8 [92.4–300] 5.3 [0.7–16.7]
 Day 4
  Median [IQR] 64.2 [18.3–247.1] 20.1 [1.5–119.1] .0121c 48.2 [16.2–138] 78.2 [22.9–297] 300 [123.4–300] 1.5 [0.8–16.9]
 Day 14
  Median [IQR] 25.4 [12.6–77.8] 108.7 [22.1–10.5] 1.0000c 25.1 [1.5–62.2] 33.2 [13.5–150.7] 119.2 [12.6–300] 4.6 [0.1–9.1]

IP investigational product, ICU intensive care unit, LVL levilimab, IL-6 interleukin 6, CRP C-reactive protein, ESR Erythrocyte Sedimentation Rate

aTwo-sided Pearson’s chi-squared test

bOne-sided Pearson’s chi-squared test

cMann–Whitney test

P  < 0.05 marked in bold