Brazilian Green Propolis Extract (EPP-AF) as an Adjunct Treatment for Hospitalized COVID-19 Patients (BeeCovid2)

D'Or Institute for Research and Education200 enrolled

Overview

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.

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

200

Conditions

Covid19 Inflammation

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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 Exclusion Criteria: * 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).

Outcomes

Primary Outcomes

Length of hospital stay

Hospitalization time after randomization (in days)

Time frame: 1-28 days

Secondary Outcomes

Percentage of participants with adverse events during the use of propolis or placebo

We will evaluate the presence or absence of symptoms related to the use of propolis or placebo.

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.

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

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

Need for Intra-Aortic Balloon Pump

Assess the need for Intra-Aortic Balloon Pump in days after randomization.

Time frame: 1-28 days

Need for Extracorporeal Oxygenation Membrane (ECMO)

Assess the need for Extracorporeal Oxygenation Membrane in days after randomization.

Time frame: 1-28 days

Brazilian Green Propolis Extract (EPP-AF) as an Adjunct Treatment for Hospitalized COVID-19 Patients (BeeCovid2)

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes