Table 5 Baseline demographic, clinical, and laboratory characteristics of patients with COVID-19 treated with either baricitinib or with standard COVID-19 therapy and results at 2 weeks from the Hospital of Prato.

Standard univariate statistical tests were performed to compare baricitinib-treated patients to age- and sex-matched controls. These consisted of the Mann-Whitney U test for pairwise comparisons, the Wilcoxon test for paired data, and Fisher’s exact test for categorical variables. Kaplan-Meier product-limit estimation and the log-rank test were used to perform a survival analysis between groups. A dose of 4 mg daily of baricitinib was given for 14 days. SpO2, peripheral capillary oxygen saturation; SBP, systolic blood pressure; DBP, diastolic blood pressure; WBC, white blood cells; MEWS, modified early warning score; CVD, cardiovascular disease; NA, not applicable; IQR, interquartile range; ICU, intensive care unit.

Features at baseline (all patients
received hydroxychloroquine and
lopinavir/ritonavir)
Baricitinib groupControl group*P value
Patient number, N (%)23 (100)18 (100)
Male/female, N (%)20/3 (87/13)14/4 (78/22)0.679
Age years, median (IQR)62.5 (57.75–72.25)64.1 (55.7–70.1)0.776
Days interval from symptoms onset
and therapy starting
6 (4–6.25)5.5 (4–5.25)0.924
Cough, N (%)17 (73.9)15 (83.3)0.709
Dyspnea, N (%)20 (86.9)14 (77.8)0.679
Sputum production, N (%)7(30.4)9 (50)0.334
Headache, N (%)8 (34.8)7 (38.9)0.757
Diarrhea, N (%)5 (21.7)5 (27.8)0.524
Ageusia/anosmia, N (%)9 (39.1)8 (44.4)0.860
Hypertension, N (%)5 (21.7)6 (33.3)0.489
Diabetes, N (%)6 (26)4 (22.2)1.000
COPD, N (%)5 (21.7)4 (22.2)1.000
CVD, N (%)4 (17.4)2 /11.1)0.679
Malignancy, N (%)1 (4.3)1 (5.5)1.000
Fever (°C)38 (37.5–38.6)37.9 (37.6–38.9)0.912
Respiratory rate (N/min)18 (16.5–23.2)21 (18–24)0.524
SpO2 (%)94 (90–95.5)92 (91–93)0.357
PaO2/FiO2, median (IQR)293 (199–296)271.4 (264–283)0.356
Pulse rate, median (IQR)84 (72.3–89.1)88 (86–94.5)0.129
SBP mm/Hg, median (IQR)110 (100–130)105 (98–115.6)0.789
DBP mm/Hg, median (IQR)70 (60–84)65.5 (60–68.5)0.589
WBC (×109/liter), median (IQR)7.6 (5.7–10.4)7.9 (7.1–8.6)0.757
Neutrophils (×109/liter), median (IQR)6,3 (4.2–7.8)7.1 (6.4–8.1)0.224
Lymphocytes (×109/liter), median (IQR)0.6 (0.5–1.1)0.72 (0.6–0.8)0.524
Hemoglobin (g/liter), median (IQR)116 (102–133.2)127 (108–136)0.565
Platelets (×109/liter), median (IQR)207 (174–232)368 (340–415)0.002
ALT (IU/liter), median (IQR)†27.6 (22.7–53.1)44 (36–50)0.176
AST (IU/liter), median (IQR)31 (25.2–47.3)44 (34.7–48)0.235
ALT (IU/liter) > upper normal limit N (%)8 (34.7)9 (50)0.358
ALT (IU/liter) > upper normal limit,
median (IQR)
50 (45.5–62.7)55 (45–68)0.707
AST (IU/liter) > upper normal limit N/%10110.350
AST (IU/liter) > upper normal limit,
median (IQR)
51.5 (44.5–76.5)67 (55–80)0.302
Creatinine (mg/dl), median (IQR)1.0 (0.9–1.3)1.1 (0.9–1.2)0.789
CRP (mg/dl), median (IQR)9.12 (5.9–16.5)4.3 (1.5–5.2)0.001
Procalcitonin (ng/ml), median (IQR)0.5 (0.3–1.0)1.1 (0.8–2.2)0.589
IL-6 (pg/ml)‡, median (IQR)29.2 (7.1–39.4)24.2 (5.2–27.6)0.189
MEWS, median (IQR)2 (1–3.1)3 (3–4)0.544
Results at 2 weeks after therapy
ICU admission N (%)05 (33)0.011
Discharged, N (%)18 (78.2)1 (5.5)<0.0001
SpO2, median (IQR)97 (94.8–98.1)92.4 (85.5–93.2)<0.0001
PaO2/FiO2 value, median (IQR)428.7 (306.1–457)277.8 (144–345)0.002
Lymphocytes (×109/liter), median (IQR)1.3 (1.2–1.9)0.8 (0.6–0.9)0.019
CRP (mg/dl), median (IQR)0.87 (0.58–2.9)5.2 (2.1–12.3)<0.0001
IL-6 (pg/ml)‡, median (IQR)6.1 (3.2–7.4)NANA
ALT (IU/liter), median (IQR)37 (24.1–57.4NANA
AST (IU/liter), median (IQR)55.4 (28–64.3)NANA

*Standard therapy group: Patients with COVID-19 under standard respiratory therapy commenced antiretrovirals (Kaletra) and hydroxychloroquine before starting the therapy with baricitinib.

†Normal ALT and AST values: 10 to 40 IU/liter.

‡IL-6 normal value: <7 pg/ml.