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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04480593
Recruitment Status : Completed
First Posted : July 21, 2020
Last Update Posted : September 30, 2020
Sponsor:
Collaborator:
Hospital Sao Rafael
Information provided by (Responsible Party):
Marcelo Silveira, D'Or Institute for Research and Education

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Covid19 Drug: Brazilian Green Propolis Extract (EPP-AF) Other: Standard care Phase 2 Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: three parallel groups randomly assigned
Masking: Single (Outcomes Assessor)
Masking Description: The individual who evaluates the results of interest to the study will not have access to the study steps before the analysis.
Primary Purpose: Treatment
Official Title: The Use of Brazilian Green Propolis Extract (EPP-AF) in Patients Affected by COVID-19: a Randomized, Open and Pilot Clinical Study.
Actual Study Start Date : June 2, 2020
Actual Primary Completion Date : August 30, 2020
Actual Study Completion Date : August 30, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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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 Name: 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 Name: Standard care


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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;
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04480593


Locations
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Brazil
Hospital Sao Rafael
Salvador, BA, Brazil, 41820340
Sponsors and Collaborators
D'Or Institute for Research and Education
Hospital Sao Rafael
Investigators
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Principal Investigator: Marcelo Silveira, MD, PhD D'Or Institute for Research and Education (IDOR)
More Information
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Publications of Results:

Other Publications:

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Responsible Party: Marcelo Silveira, Principal Investigator, D'Or Institute for Research and Education
ClinicalTrials.gov Identifier: NCT04480593    
Other Study ID Numbers: 31099320.6.0000.0048
First Posted: July 21, 2020    Key Record Dates
Last Update Posted: September 30, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Marcelo Silveira, D'Or Institute for Research and Education:
Propolis
Covid19
SARS-CoV-2
Anti-inflammatory
Additional relevant MeSH terms:
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COVID-19
Pneumonia, Viral
Pneumonia
Respiratory Tract Infections
Infections
Virus Diseases
Coronavirus Infections
 Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Propolis
Anti-Infective Agents