The Use of Brazilian Green Propolis Extract (EPP-AF) in Patients Affected by COVID-19. (Bee-Covid)

D'Or Institute for Research and Education

Status and phase: Completed; Phase 3; Phase 2

Conditions: Covid19

Treatments: Drug: Brazilian Green Propolis Extract (EPP-AF); Other: Standard care

Study type: Interventional

Funder types: Other

Identifiers

NCT04480593

31099320.6.0000.0048

Details and patient eligibility

About

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.

Enrollment: 120 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Hospitalized patients;
• Positive RT-PCR for SARS-CoV-2;
• 18 Years and older.

Exclusion criteria

• Pregnant women;
• People with active cancer;
• Patients undergoing transplantation of solid organs or bone marrow or who use immunosuppressive medications;
• HIV carriers;
• Allergy to propolis or any of its components;
• Bacterial infection at randomization;
• Sepsis or septic shock before randomization;
• Patients unable to use medication orally or via nasoenteral tube;
• Patients with severe chronic liver disease (Child B or C);
• Patients with advanced heart failure;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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120 participants in 3 patient groups

Control

Active Comparator group

Description:

standard care.

Treatment:

Other: Standard care

EPP-AF 400mg/day

Experimental group

Description:

Green propolis extract (EPP-AF) at a dose of 400mg / day in addition to the standard treatment.

Treatment:

Drug: Brazilian Green Propolis Extract (EPP-AF)

EPP-AF 800mg/day

Experimental group

Description:

Green propolis extract (EPP-AF) at a dose of 800mg / day in addition to the standard treatment.

Treatment:

Drug: Brazilian Green Propolis Extract (EPP-AF)