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Table 1 Patient characteristics

From: A multicenter, double-blind, randomized, parallel-group, placebo-controlled study to evaluate the efficacy and safety of camostat mesilate in patients with COVID-19 (CANDLE study)

 

Camostat mesilate (N = 78)

Placebo (N = 77)

Total (N = 155)

Sex

 Male

35 (44.9)

43 (55.8)

78 (50.3)

 Female

43 (55.1)

34 (44.2)

77 (49.7)

Race

 Asian

78 (100.0)

77 (100.0)

155 (100.0)

Age at the time of consent (years)

 ≥ 65

30 (38.5)

29 (37.7)

59 (38.1)

 < 65

48 (61.5)

48 (62.3)

96 (61.9)

 Mean ± standard deviation

55.7 ± 18.8

56.1 ± 18.2

55.9 ± 18.4

 Median (range)

59.0 (21–89)

56.0 (21–94)

58.0 (21–94)

BMI (kg/m2)

 Mean ± standard deviation

24.5 ± 5.2

23.9 ± 3.7

24.2 ± 4.5

 Median (range)

23.9 (14.1–46.2)

23.2 (18.4–33.5)

23.8 (14.1–46.2)

Underlying diseasesa

36 (46.2)

35 (45.5)

71 (45.8)

 Chronic respiratory disease

11 (14.1)

14 (18.2)

25 (16.1)

 Chronic kidney disease

5 (6.4)

4 (5.2)

9 (5.8)

 Diabetes mellitus

15 (19.2)

12 (15.6)

27 (17.4)

 Hypertension

24 (30.8)

20 (26.0)

44 (28.4)

 Cardiovascular disease

4 (5.1)

4 (5.2)

8 (5.2)

 Obesity (BMI ≥ 30 kg/m2)

9 (11.5)

6 (7.8)

15 (9.7)

Duration from the onset dateb (days)

 < 4

43 (55.1)

34 (44.2)

77 (49.7)

 ≥ 4

35 (44.9)

43 (55.8)

78 (50.3)

 Mean ± standard deviation

3.3 ± 1.2

3.5 ± 1.1

3.4 ± 1.2

 Median (range)

3.0 (0–5)

4.0 (1–5)

4.0 (0–5)

Test method used at the study site to measure COVID-19 viral load

 RT-PCR

71 (91.0)

71 (92.2)

142 (91.6)

 LAMP test

7 (9.0)

5 (6.5)

12 (7.7)

 Missing

0

1 (1.3)

1 (0.6)

Sample type used for negative/positive determination

 Nasopharyngeal swab

56 (71.8)

52 (67.5)

108 (69.7)

 Nasal swab

9 (11.5)

7 (9.1)

16 (10.3)

 Saliva

13 (16.7)

17 (22.1)

30 (19.4)

 Missing

0

1 (1.3)

1 (0.6)

SARS-CoV-2 viral load (central laboratory) (log10 copies/mL)

 < 7

39 (50.0)

45 (58.4)

84 (54.2)

 ≥ 7

39 (50.0)

32 (41.6)

71 (45.8)

 Mean ± standard deviation

6.69 ± 1.48

6.41 ± 1.69

6.55 ± 1.59

 Median (range)

6.98 (3.40–9.08)

6.61 (3.40–9.40)

6.91 (3.40–9.40)

Ordinal scale for severity

 3: Hospitalized, no oxygen therapy

78 (100.0)

77 (100.0)

155 (100.0)

Presence of lung lesions

38 (48.7)

42 (54.5)

80 (51.6)

IgM antibody test (central laboratory)

 Positive

1 (1.3)

2 (2.6)

3 (1.9)

 Negative

77 (98.7)

75 (97.4)

152 (98.1)

 Mean ± standard deviation

0.023 ± 0.081

0.042 ± 0.180

0.033 ± 0.139

 Median (range)

0.010 (0.00–0.72)

0.010 (0.00–1.14)

0.010 (0.00–1.14)

IgG antibody test (central laboratory)

 Positive

2 (2.6)

0

2 (1.3)

 Negative

76 (97.4)

77 (100.0)

153 (98.7)

 Mean ± standard deviation

0.078 ± 0.470

0.011 ± 0.009

0.045 ± 0.334

 Median (range)

0.010 (0.00–3.91)

0.010 (0.00–0.08)

0.010 (0.00–3.91)

Presence of clinical symptoms

55 (70.5)

53 (68.8)

108 (69.7)

  1. Values are n (%) unless otherwise stated
  2. BMI body mass index, RT-PCR reverse transcriptase-polymerase chain reaction, LAMP loop-mediated isothermal amplification, Ig immunoglobulin
  3. aIncludes the following: chronic respiratory disease, chronic kidney disease, diabetes mellitus, hypertension, cardiovascular disease, and obesity (BMI ≥ 30 kg/m2)
  4. bDuration from COVID-19 symptoms onset date (for asymptomatic patients, the collection date of the sample with positive confirmation) to the registration date