The COVID-19 pandemic is of grave concern due its impact on human health and on the economy. Propolis, a natural resin produced by bees from plant materials, has anti-inflammatory, immunomodulatory, anti-oxidant properties, and various aspects of the SARS-CoV-2 infection mechanism are potential targets for propolis compounds. Propolis components have inhibitory effects on the ACE2, TMPRSS2 and PAK1 signaling pathways; in addition, antiviral activity has been proven in vitro and in vivo. This is a pilot randomized study that aims to assess the impact of using Brazilian green propolis extract against the deleterious effects of the new coronavirus.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
120
Green propolis extract (EPP-AF) administered orally or via nasoenteral tube.
Standard treatment includes, as needed, supplemental oxygen (non-invasive and invasive), antibiotics or antivirals, corticosteroids, vasopressor support, renal replacement therapy and extracorporeal membrane oxygenation (ECMO).
Hospital Sao Rafael
Salvador, Estado de Bahia, Brazil
Composite clinical outcome with oxygen therapy dependency time or hospitalization time
Composite clinical outcome with oxygen therapy dependency time (in days) or hospitalization time (in days) after randomization.
Time frame: 1-28 days
Percentage of participants with adverse events during the use of propolis
We will evaluate the presence or absence of symptoms related to the use of propolis through a questionnaire.
Time frame: 1-28 days
Rate and severity of acute kidney injury during the study
Assess the degree of acute kidney injury according to KDIGO (through serum creatinine or urine output).
Time frame: 1-28 days
Renal replacement therapy.
Assess need or not for renal replacement therapy.
Time frame: 1-28 days
Rate of need for vasopressor use
Describe the time needed for vasopressors in days after randomization
Time frame: 1-28 days
Need for intensive care unit (ICU)
Assess length of stay in the ICU after randomization in days
Time frame: 1-28 days
Intensive care unit (ICU) readmission
Rate of readmission to the ICU after randomization
Time frame: 1-28 days
Invasive oxygenation time
Assess the need for mechanical ventilation in days after randomization.
Time frame: 1-28 days
Variation of plasma c-reactive protein
Evaluate the variation in serum levels of c-reactive protein over the 7 days after randomization
Time frame: 1-7 days
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