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

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ClinicalTrials.gov Identifier: NCT04800224
Recruitment Status : Recruiting
First Posted : March 16, 2021
Last Update Posted : April 14, 2021
Sponsor:
Collaborator:
Apis Flora Industrial e Comercial Ltda
Information provided by (Responsible Party):
Marcelo Augusto Duarte Silveira, MD, PhD, D'Or Institute for Research and Education

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Covid19 Inflammation Drug: Standardized Brazilian Green Propolis Extract Drug: Placebo Phase 2 Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: A randomized, double-blind, placebo-controlled trial
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: The capsules will be coated, in opaque and equal packaging, so that the researchers involved in the care of patients could not distinguish between propolis and placebo. Neither the participants, nor the principal investigator, nor the health professionals involved in the care will know which group the patients will be allocated.
Primary Purpose: Treatment
Official 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
Actual Study Start Date : April 12, 2021
Estimated Primary Completion Date : June 30, 2021
Estimated Study Completion Date : July 30, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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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 Name: Propolis


Outcome Measures
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Primary Outcome Measures :
  1. Length of hospital stay [ Time Frame: 1-28 days ]
    Hospitalization time after randomization (in days)


Secondary Outcome Measures :
  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 Outcome Measures:
  1. Death [ Time Frame: 1-28 days ]
    Assess mortality rate


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:

  • 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).
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): NCT04800224


Contacts
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Contact: Marcelo AD Silveira, MD, PhD +55 71 3281-6543 marceloadsilveira@gmail.com

Locations
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Brazil
Hospital Sao Rafael Recruiting
Salvador, BA, Brazil, 41820340
Contact: Marcelo Silveira, MD, PhD    +55 71 3281-6543    marceloadsilveira@gmail.com   
Contact: Suzete Guarda, MD, PhD    +55 71 3281-6000    suzete.farias@hsr.com.br   
Sponsors and Collaborators
D'Or Institute for Research and Education
Apis Flora Industrial e Comercial Ltda
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:
MAD Silveira, D De Jong, AA Berretta, et.al. Efficacy of propolis as an adjunct treatment for hospitalized COVID-19 patients: a randomized, controlled clinical trial. MedRxiv preprint doi: https://doi.org/10.1101/2021.01.08.20248932.

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Responsible Party: Marcelo Augusto Duarte Silveira, MD, PhD, Principal Investigator, D'Or Institute for Research and Education
ClinicalTrials.gov Identifier: NCT04800224    
Other Study ID Numbers: 31099320.6.0000.0049
First Posted: March 16, 2021    Key Record Dates
Last Update Posted: April 14, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: The data presented in this study are available on request from the corresponding author.

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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 Augusto Duarte Silveira, MD, PhD, D'Or Institute for Research and Education:
Propolis
Covid19
Anti-Inflammatory Agents
Immunoregulation
Additional relevant MeSH terms:
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COVID-19
Inflammation
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
 Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Pathologic Processes
Propolis
Anti-Infective Agents