Table 1 Baseline characteristics of patients of mITTa population.

From: Standardized Brazilian green propolis extract (EPP-AF®) in COVID-19 outcomes: a randomized double-blind placebo-controlled trial

Characteristics

Propolis (n = 98)

Placebo (n = 90)

Total (n = 188)

Sex, Male

54/98 (55.1%)

64/90 (71.1%)

118/188 (62.8%)

Age, years, mean ± SD

47.9 ± 12.5

46.7 ± 12.4

47.3 ± 12.4

Vaccinated for COVID 19

20/98 (20.4%)

21/90 (23.3%)

41/187 (21.9%)

Clinical presentation

Oxygen support

 None

66/98 (67.3%)

58/90 (64.4%)

124/188 (66.0%)

 O2 catheter ˂ 5L/min

27/98 (27.6%)

26/90 (28.9%)

53/188 (28.2%)

 O2 catheter ≥ 5L/min, high-flow or NIV

5/98 (5.1%)

6/90 (6.7%)

11/188 (5.9%)

Tomography results

 Clean image

3/97 (3.1%)

1/90 (1.1%)

4/187 (2.1%)

  < 25%

12/97 (12.4%)

11/90 (12.2%)

23/187 (12.3%)

 25–50%

63/97 (64.9%)

62/90 (68.9%)

125/187 (66.8%)

 50–75%

19/97 (19.6%)

16/90 (17.8%)

35/187 (18.7%)

 Temperature, ºC

36.5 ± 1.1

36.5 ± 1.1

36.5 ± 1.1

 SpO2 on admission < 93%

12/97 (12.4%)

10/89 (11.2%)

22/186 (11.8%)

 RR on admission > 24 irpm

4/97 (4.1%)

6/90 (6.7%)

10/187 (5.3%)

 SBP < 90 mmHg

2/94 (2.1%)

0/83 (0.0%)

2/177 (1.1%)

 Randomization in ICU

26/94 (27.7%)

25/83 (30.1%)

51/177 (28.8%)

Comorbidities

 Diabetes

8/98 (8.2%)

10/90 (11.1%)

18/188 (9.6%)

 Hypertension

26/98 (26.5%)

22/90 (24.4%)

48/188 (25.5%)

 COPD

1/98 (1.0%)

5/90 (5.6%)

6/188 (3.2%)

 Obesity

12/98 (12.2%)

12/90 (13.3%)

24/188 (12.8%)

 Stroke

0/98 (0.0%)

0/90 (0.0%)

0/188 (0.0%)

 Myocardial infarction

1/98 (1.0%)

0/90 (0.0%)

1/188 (0.5%)

Baseline treatment

 Antibiotics

63/97 (64.9%)

63/90 (70.0%)

126/187 (67.4%)

 Tamiflu

0/97 (0.0%)

1/90 (1.1%)

1/187 (0.5%)

 Hydroxychloroquine

3/97 (3.1%)

2/90 (2.2%)

5/187 (2.7%)

 Corticosteroids

82/97 (84.5%)

83/90 (92.2%)

165/187 (88.2%)

 Tocilizumab

2/97 (2.1%)

5/89 (5.6%)

7/186 (3.8%)

 Pentaglobin

1/97 (1.0%)

1/90 (1.1%)

2/187 (1.1%)

 Remdesivir

0/61 (0.0%)

2/47 (4.3%)

2/108 (1.9%)

  1. COPD, chronic obstructive pulmonary disease; ICU, intensive care unit; NIV, non-invasive ventilation; O2, oxygen; RR, respiratory frequency; SBP, systolic blood pressure; SD, standard deviation; SpO2, peripheral O2 saturation.
  2. amITT: Modified intention-to-treat population (all randomized patients < 80 years who received propolis or placebo at least one time).