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

May 11, 2022 updated by: Marcelo Augusto Duarte Silveira, MD, PhD, D'Or Institute for Research and Education

The Use of the Standardized Brazilian Green Propolis Extract (EPP-AF) as an Adjunct Treatment for Hospitalized COVID-19 Patients: A Randomized, Double-blind, Placebo-controlled Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

200

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:

  • 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).

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: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 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.
Drug: Placebo
900mg/day of Placebo for 10 days.
Active Comparator: Propolis
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.
Drug: Standardized Brazilian Green Propolis Extract
900mg/day of Standardized Brazilian Green Propolis Extract for 10 days.
Other Names:
  • Propolis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Length of hospital stay
Time Frame: 1-28 days
Hospitalization time after randomization (in days)
1-28 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Percentage of participants with adverse events during the use of propolis or placebo
Time Frame: 1-28 days
We will evaluate the presence or absence of symptoms related to the use of propolis or placebo.
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.
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 Intra-Aortic Balloon Pump
Time Frame: 1-28 days
Assess the need for Intra-Aortic Balloon Pump in days after randomization.
1-28 days
Need for Extracorporeal Oxygenation Membrane (ECMO)
Time Frame: 1-28 days
Assess the need for Extracorporeal Oxygenation Membrane in days after randomization.
1-28 days

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Death
Time Frame: 1-28 days
Assess mortality rate
1-28 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

Apis Flora Industrial e Comercial Ltda

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)

April 12, 2021

Primary Completion (Actual)

July 30, 2021

Study Completion (Actual)

July 30, 2021

Study Registration Dates

First Submitted

March 12, 2021

First Submitted That Met QC Criteria

March 15, 2021

First Posted (Actual)

March 16, 2021

Study Record Updates

Last Update Posted (Actual)

May 13, 2022

Last Update Submitted That Met QC Criteria

May 11, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 31099320.6.0000.0049

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

The data presented in this study are available on request from the corresponding author.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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