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

D'Or Institute for Research and Education

Status and phase: Completed; Phase 3; Phase 2

Conditions: Inflammation; Covid19

Treatments: Drug: Placebo; Drug: Standardized Brazilian Green Propolis Extract

Study type: Interventional

Funder types: Other

Identifiers

NCT04800224

31099320.6.0000.0049

Details and patient eligibility

About

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.

Full 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).

Enrollment: 200 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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200 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo

Propolis

Active Comparator group

Description:

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.

Treatment:

Drug: Standardized Brazilian Green Propolis Extract