Table 1 Baseline demographics and clinical characteristics

Age (years), median (IQR)

60 (49–69)

59 (49–68)

60 (50–70)

n/N (%)

 < 60

137/275 (49.8)

70/139 (50.4)

67/136 (49.3)

 ≥ 60

138/275 (50.2)

69/139 (49.6)

69/136 (50.7)

Gender, n/N (%)

Male

211/275 (76.7)

112/139 (80.6)

99/136 (72.8)

Female

64/275 (23.3)

27/139 (19.4)

37/136 (27.2)

Country, n/N (%)

Austria

6/275 (2.2)

2/139 (1.4)

4/136 (2.9)

Belgium

8/275 (2.9)

2/139 (1.4)

6/136 (4.4)

France

89/275 (32.4)

48/139 (34.5)

41/136 (30.1)

Ireland

9/275 (3.3)

5/139 (3.6)

4/136 (2.9)

Italy

24/275 (8.7)

12/139 (8.6)

12/136 (8.8)

Luxembourg

1/275 (0.4)

1/139 (0.7)

0/136 (0.0)

Norway

123/275 (44.7)

61/139 (43.9)

62/136 (45.6)

Portugal

3/275 (1.1)

2/139 (1.4)

1/136 (0.7)

Spain

12/275 (4.4)

6/139 (4.3)

6/136 (4.4)

Comorbidities, n/N (%)

Obesity (BMI ≥ 30 kg/m²)

99/257 (38.5)

53/127 (41.7)

46/130 (35.4)

Diabetes

61/274 (22.3)

36/139 (25.9)

25/135 (18.5)

Hypertension

85/274 (31.0)

44/139 (31.7)

41/135 (30.4)

Chronic obstructive pulmonary disease

14/274 (5.1)

9/139 (6.5)

5/135 (3.7)

Chronic cardiac disease

52/274 (19.0)

24/139 (17.3)

28/135 (20.7)

Chronic kidney disease

11/274 (4.0)

6/139 (4.3)

5/135 (3.7)

Chronic liver disease

5/274 (1.8)

3/139 (2.2)

2/135 (1.5)

Cancer

10/274 (3.6)

4/139 (2.9)

6/135 (4.4)

Autoimmune disease

12/274 (4.4)

3/139 (2.2)

9/135 (6.7)

Immunodeficiency

4/274 (1.5)

2/139 (1.4)

2/135 (1.5)

Any comorbidities, n/N (%)

199/275 (72.4)

107/139 (77.0)

92/136 (67.6)

Days from first confirmed SARS-CoV-2 PCR to randomisation, median (IQR)

6 (3–9)

6 (3–8)

7 (3–10)

Days from symptoms onset to randomisation, median (IQR)

9 (7–11)

9 (7–11)

10 (8–12)

n/N (%)

 ≤ 7

74/275 (26.9)

40/139 (28.8)

34/136 (25.0)

8–13

187/275 (68.0)

94/139 (67.6)

93/136 (68.4)

 ≥ 14

14/275 (5.1)

5/139 (3.6)

9/136 (6.6)

COVID-19 vaccination, number of injections, n/N (%)

0 injection

175/275 (63.6)

87/139 (62.6)

88/136 (64.7)

 ≥ 1 injection

96/275 (34.9)

49/139 (35.2)

47/136 (34.6)

Unknown

4/275 (1.5)

3/139 (2.2)

1/136 (0.7)

WHO disease progression score, n/N (%)

6 (severe disease)

236/275 (85.8)

121/139 (87.1)

115/136 (84.6)

7–9 (critical disease)

39/275 (14.2)

18/139 (12.9)

21/136 (15.4)

Concomitant medications, n/N (%)

Remdesivir

8/275 (2.9)

6/139 (4.3)

2/136 (1.5)

Systemic corticosteroids

261/275 (94.9)

133/139 (95.7)

128/136 (94.1)

Anticoagulants

250/275 (90.9)

130/139 (93.5)

120/136 (88.2)

Biochemistry, median (IQR)

Lymphocyte count (10⁹ cells/L)

N

268

135

133

Median (IQR)

0.8 (0.5–1.1)

0.8 (0.6–1.2)

0.7 (0.5–1.0)

Neutrophil count (10⁹ cells/L)

N

268

135

133

Median (IQR)

6.0 (4.2–8.3)

6.0 (4.2–8.4)

6.0 (4.2–8.3)

C-reactive protein (mg/L)

N

268

134

134

Median (IQR)

87 (49–140)

77 (35–126)

95 (55–149)

Ferritin (ng/mL)

N

228

116

112

Median (IQR)

1121 (595–1887)

1039 (609–1887)

1206 (559–1883)

Lactate dehydrogenase (U/L)

N

235

120

115

Median (IQR)

404 (321–518)

397 (318–526)

436 (323–514)

Procalcitonin (ng/mL)

N

187

95

92

Median (IQR)

0.2 (0.1–0.3)

0.2 (0.1–0.4)

0.1 (0.1–0.3)

D-dimer (μg/L FEU)

N

243

119

124

Median (IQR)

900 (600–1500)

844 (620–1360)

904 (594–1592)

SARS-CoV2 serostatus

N

124

65

59

Negative

46/124 (37.1)

21/65 (32.3)

25/59 (42.4)

Positive

78/124 (62.9)

44/65 (67.7)

34/59 (57.6)

Nasopharyngeal viral load, (Log copies/10000 cells) median (IQR)*

N

124

65

59

Median (IQR)

3.2 (2.1–4.5)

3.2 (2.3–4.5)

3.2 (1.8–4.5)

Viral load value < LOQ

18/124 (14.5)

9/65 (13.9)

9/59 (15.3)