Skip to main content
OpenTrials
Completed

NCT Number: NCT04480593

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Covid19 COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

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

Who can participate

Healthy volunteers accepted: No

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

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;

Treatment and study plan

Brazilian Green Propolis Extract (EPP-AF)

Drug

Green propolis extract (EPP-AF) administered orally or via nasoenteral tube.

Other names: Standard care

Standard care

Other

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).

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  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 (through serum creatinine or urine output).

  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. Need for intensive care unit (ICU)

    Time frame: 1-28 days

    Assess length of stay in the ICU after randomization in days

  6. Intensive care unit (ICU) readmission

    Time frame: 1-28 days

    Rate of readmission to the ICU after randomization

  7. Invasive oxygenation time

    Time frame: 1-28 days

    Assess the need for mechanical ventilation in days after randomization.

  8. 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

Sponsors and collaborators

Lead sponsor

D'Or Institute for Research and Education

Other

Collaborators

  • Hospital Sao Rafael

Registry information

Official study title

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

Acronym: Bee-Covid

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jul 21, 2020
Registry last updated
Sep 30, 2020

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.