Table 2 BeeCovid Study Outcomes (mITTc population).

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

Outcomes

EPP-AF

Placebo

Statistical effect

Adjusteda

Unadjusted

(n = 98)

(n = 90)

Estimate (95% CI)

p-value

Estimate (95% CI)

p-value

Primary outcome

 Length of hospital stay, days

  Mean (95% CI)

6.48 ± 5.99 (n = 98)

7.72 ± 7.06 (n = 90)

MD

− 0.74 [− 1.94 to 0.42]

0.22

− 1.14 [− 3.16 to 0.82]

0.26

  Median (IQR)

4 [3-8]

5 [3-9]

–

–

–

–

–

  Length of hospital stay (vaccination status), days

  Vaccinated

8.2 ± 6.8 (n = 20)

8.7 ± 8 (n = 21)

MD

0.57 [− 3.43 to 4.58

0.78

− 0.47 [− 4.48 to 3.55]

0.82

  Non-vaccinated

6.0 ± 5.7 (n = 78)

7.4 ± 6.8 (n = 69)

MD

− 1.56 [− 3.64 to 0.53]

0.14

− 1.40 [− 3.52 to 0.73]

0.20

Secondary outcomes

 Secondary infection

6/98 (6.1%)

17/90 (18.9%)

OR

0.28 [0.1 to 0.76]

0.01

0.28 [0.11 to 0.75]

0.01

 Acute kidney injury, No. (%)

13/98 (13.3%)

16/90 (17.8%)

OR

0.71 [0.32 to 1.57]

0.40

0.71 [0.32 to 1.57]

0.39

 AKI KDIGO

  1

11/98 (11.2%)

13/90 (14.4%)

     

  2

1/98 (1%)

3/90 (3.3%)

     

  3

1/98 (1%)

0/90 (0%)

     

 Renal Replacement Therapy, No. (%)

0/98 (0%)

0/90 (0%)

OR

–

–

–

1.00

 Need of vasopressor use, No. (%)

5/97 (5.2%)

5/90 (5.6%)

OR

0.98 [0.27—3.58]

0.97

0.92 [0.26 to 3.30]

0.90

 Need of MV, No. (%)

10/98 (10.2%)

12/90 (13.3%)

OR

0.75 [0.31 to 1.85]

0.54

0.74 [0.30 to 1.80]

0.51

  Days in MV, mean (SD)

0.71 ± 2.4 (n = 98)

0.86 ± 2.77 (n = 90)

MD

− 0.05 [− 0.78 to 0.59]

0.84

− 0.15 [− 0.99 to 0.64]

0.70

 ICU admission, No. (%)

23/97 (23.7%)

24/89 (27%)

OR

0.85 [0.44 to 1.66]

0.63

0.84 [0.43 to 1.63]

0.61

 Need for IAB, No. (%)

0/98 (0%)

0/90 (0%)

OR

–

–

–

1.00b

 Need for ECMO, No. (%)

0/98 (0%)

0/89 (0%)

OR

–

–

–

1.00b

 Death, No. (%)

0/98 (0%)

0/90 (0%)

OR

–

–

–

1.00b

Exploratory outcomes, No. (%)

 Thromboembolic events

2/98 (2%)

1/90 (1.1%)

OR

2.17 [0.18 to 25.59]

0.54

1.85 [0.17 to 20.8]

0.62

 Bleeding

1/98 (1%)

1/89 (1.1%)

OR

0.96 [0.06 to 16.22]

0.98

0.91 [0.06 to 14.72]

0.95

 Platelets < 100.000

4/98 (4.1%)

5/90 (5.6%)

OR

0.70 [0.18 to 2.72]

0.61

0.72 [0.19 to 2.78]

0.64

 Neurological alterations

1/98 (1%)

0/90 (0%)

OR

–

–

–

1.00b

  Neurological lesions

0/98 (0%)

0/90 (0%)

OR

–

–

–

1.00b

 Leukocytes < 1000

1/98 (1%)

0/90 (0%)

OR

–

–

–

1.00b

  1. ECMO, extracorporeal oxygenation membrane; IAB, intra-aortic balloon; ICU, intensive care unit; MD, mean differences; MV, mechanical ventilation; OR, odds ratio; POR, proportional odds ratio; SD, standard deviation.
  2. aAll models were adjusted for oxygen support at baseline (stratification variable): None; O2 catheter < 5L; O2 catheter ≥ 5L, or high flow, or non-invasive ventilation.
  3. bFisher’s exact test.
  4. cmITT: Modified intention-to-treat population (all randomized patients < 80 years who received propolis or placebo at least one time).
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