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Completed

NCT Number: NCT04800224

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Hospital Sao Rafael

Salvador, Estado de Bahia, 41820340, Brazil

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Standardized Brazilian Green Propolis Extract

Drug

900mg/day of Standardized Brazilian Green Propolis Extract for 10 days.

Other names: Propolis

Placebo

Drug

900mg/day of Placebo for 10 days.

Primary outcomes

  1. Length of hospital stay

    Time frame: 1-28 days

    Hospitalization time after randomization (in days)

Secondary outcomes

  1. 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.

  2. 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.

  3. Renal replacement therapy.

    Time frame: 1-28 days

    Assess need or not for renal replacement therapy

  4. Rate of need for vasopressor use.

    Time frame: 1-28 days

    Describe the time needed for vasopressors in days after randomization.

  5. Intensive care unit (ICU) readmission

    Time frame: 1-28 days

    Rate of readmission to the ICU after randomization

  6. Invasive oxygenation time

    Time frame: 1-28 days

    Assess the need for mechanical ventilation in days after randomization.

  7. Need for Intra-Aortic Balloon Pump

    Time frame: 1-28 days

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

  8. Need for Extracorporeal Oxygenation Membrane (ECMO)

    Time frame: 1-28 days

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

Other outcomes

  1. Death

    Time frame: 1-28 days

    Assess mortality rate

Sponsors and collaborators

Lead sponsor

D'Or Institute for Research and Education

Other

Collaborators

  • Apis Flora Industrial e Comercial Ltda

Registry information

Official study title

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

Acronym: BeeCovid2

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Mar 16, 2021
Registry last updated
May 13, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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