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

September 28, 2020 updated by: Marcelo Silveira, D'Or Institute for Research and Education

The Use of Brazilian Green Propolis Extract (EPP-AF) in Patients Affected by COVID-19: a Randomized, Open and Pilot Clinical Study.

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • BA
      • Salvador, BA, Brazil, 41820340
        • Hospital Sao Rafael

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control
standard care.
Other: Standard care
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).
Experimental: EPP-AF 400mg/day
Green propolis extract (EPP-AF) at a dose of 400mg / day in addition to the standard treatment.
Drug: Brazilian Green Propolis Extract (EPP-AF)
Green propolis extract (EPP-AF) administered orally or via nasoenteral tube.
Other Names:
  • Standard care
Experimental: EPP-AF 800mg/day
Green propolis extract (EPP-AF) at a dose of 800mg / day in addition to the standard treatment.
Drug: Brazilian Green Propolis Extract (EPP-AF)
Green propolis extract (EPP-AF) administered orally or via nasoenteral tube.
Other Names:
  • Standard care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Composite clinical outcome with oxygen therapy dependency time or hospitalization time
Time Frame: 1-28 days
Composite clinical outcome with oxygen therapy dependency time (in days) or hospitalization time (in days) after randomization.
1-28 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of participants with adverse events during the use of propolis
Time Frame: 1-28 days
We will evaluate the presence or absence of symptoms related to the use of propolis through a questionnaire.
1-28 days
Rate and severity of acute kidney injury during the study
Time Frame: 1-28 days
Assess the degree of acute kidney injury according to KDIGO (through serum creatinine or urine output).
1-28 days
Renal replacement therapy.
Time Frame: 1-28 days
Assess need or not for renal replacement therapy.
1-28 days
Rate of need for vasopressor use
Time Frame: 1-28 days
Describe the time needed for vasopressors in days after randomization
1-28 days
Need for intensive care unit (ICU)
Time Frame: 1-28 days
Assess length of stay in the ICU after randomization in days
1-28 days
Intensive care unit (ICU) readmission
Time Frame: 1-28 days
Rate of readmission to the ICU after randomization
1-28 days
Invasive oxygenation time
Time Frame: 1-28 days
Assess the need for mechanical ventilation in days after randomization.
1-28 days
Variation of plasma c-reactive protein
Time Frame: 1-7 days
Evaluate the variation in serum levels of c-reactive protein over the 7 days after randomization
1-7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

D'Or Institute for Research and Education

Collaborators

Hospital Sao Rafael

Investigators

  • Principal Investigator: Marcelo Silveira, MD, PhD, D'Or Institute for Research and Education (IDOR)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 2, 2020

Primary Completion (Actual)

August 30, 2020

Study Completion (Actual)

August 30, 2020

Study Registration Dates

First Submitted

July 12, 2020

First Submitted That Met QC Criteria

July 20, 2020

First Posted (Actual)

July 21, 2020

Study Record Updates

Last Update Posted (Actual)

September 30, 2020

Last Update Submitted That Met QC Criteria

September 28, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 31099320.6.0000.0048

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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