Table 2.
Probiotic | Placebo | RR (95 CI) | P-valuec | |
---|---|---|---|---|
Primary outcomes | ||||
Complete remissiona [n, %] | 78/147 (53.1%) | 41/146 (28.1%) | 1.89 (1.40–2.55) | <0.001 |
Hospitalized, moderateb [n, %] | 0/150 | 0/150 | - | 1.000 |
Hospitalized, severeb [n, %] | 0/150 | 0/150 | - | 1.000 |
Days of ICU stay [mean, SD] | 0 ± 0 | 0 ± 0 | - | 1.000 |
Death [n, %] | 0/150 | 0/150 | - | 1.000 |
Safety outcomes | ||||
Patients with ≥ 1 AE [n, %] | 41/150 (27.3%) | 63/150 (42.0%) | 0.65 (0.47–0.90) | 0.008 |
|
7/24 (29.2%) | 8/18 (44.4%) | 0.66 (0.29–1.48) | 0.312 |
Patients with ≥ 1 SAE [n, %] | 0/150 | 0/150 | - | 1.000 |
AE: Adverse Event. CI: Confidence Interval. ICU: Intensive Care Unit. SAE: Severe Adverse Event. SD: Standard Deviation. a) Requires negative RT-qPCR (viral clearance) plus complete resolution of all five Covid19 symptoms considered at study entry (symptomatic clearance). b) As per WHO Clinical Progression Scale.17 c) Calculated by Pearson Chi-squared test, Bonferroni-corrected threshold for significance is P = 0.01.