Brazilian Green Propolis Extract (EPP-AF) as an Adjunct Treatment for Hospitalized COVID-19 Patients (BeeCovid2)
- Conditions
- Covid19Inflammation
- Interventions
- Drug: PlaceboDrug: Standardized Brazilian Green Propolis Extract
- Registration Number
- NCT04800224
- Lead Sponsor
- D'Or Institute for Research and Education
- Brief Summary
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) promotes challenging immune and inflammatory phenomena. Though various therapeutic possibilities have been tested against coronavirus disease 2019 (COVID-19), the most adequate treatment has not yet been established. Among candidate adjunct treatment options, propolis, produced by honey bees from bioactive plant exudates, has shown potential against viral targets and has demonstrated immunoregulatory properties.
- Detailed Description
To evaluate the efficacy and safety of oral propolis as an adjunct treatment for SARS-CoV-2 infection, we designed a randomized, double-blind, placebo-controlled trial (Bee-Covid2) (The Use of Brazilian Green Propolis Extract (EPP-AF®) in Patients Affected by COVID-19).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 200
- Older than 18 years;
- Diagnosis of coronavirus infection confirmed by polymerase chain reaction - reverse transcriptase testing;
- Symptoms started within 14 days of the randomization date
- Pregnant or lactating women;
- Known hypersensitivity to propolis;
- Propolis use less than 30 days from the randomization date;
- Active cancer;
- Human immunodeficiency virus carriers;
- Patients undergoing transplantation of solid organs or bone marrow or who were using immunosuppressive medications;
- Bacterial infection at randomization, sepsis or septic shock related to bacterial infection at randomization;
- Impossibility of using the medication orally or by nasoenteral tube;
- Known hepatic failure or advanced heart failure (New York Heart Association [NYHA] class III or IV).
- End Stage Renal Disease (ESRD).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Patients in the Placebo group will receive an identical number of capsules containing 900 mg / day of placebo (3 capsules of 100 mg each, divided into 3 daily doses); for 10 days. Propolis Standardized Brazilian Green Propolis Extract Participants in the Propolis group will receive propolis EPP-AF at a dose of 900 mg / day (3 capsules of 100 mg each, divided into 3 daily doses); for 10 days.
- Primary Outcome Measures
Name Time Method Length of hospital stay 1-28 days Hospitalization time after randomization (in days)
- Secondary Outcome Measures
Name Time Method Percentage of participants with adverse events during the use of propolis or placebo 1-28 days We will evaluate the presence or absence of symptoms related to the use of propolis or placebo.
Rate and severity of acute kidney injury during the study 1-28 days Assess the degree of acute kidney injury according to KDIGO.
Renal replacement therapy. 1-28 days Assess need or not for renal replacement therapy
Invasive oxygenation time 1-28 days Assess the need for mechanical ventilation in days after randomization.
Need for Intra-Aortic Balloon Pump 1-28 days Assess the need for Intra-Aortic Balloon Pump in days after randomization.
Rate of need for vasopressor use. 1-28 days Describe the time needed for vasopressors in days after randomization.
Intensive care unit (ICU) readmission 1-28 days Rate of readmission to the ICU after randomization
Need for Extracorporeal Oxygenation Membrane (ECMO) 1-28 days Assess the need for Extracorporeal Oxygenation Membrane in days after randomization.
Trial Locations
- Locations (1)
Hospital Sao Rafael
🇧🇷Salvador, BA, Brazil