The Use of Brazilian Green Propolis Extract (EPP-AF) in Patients Affected by COVID-19.
Bee-Covid
1 other identifier
interventional
120
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 covid19
Started Jun 2020
Shorter than P25 for phase_2 covid19
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 2, 2020
CompletedFirst Submitted
Initial submission to the registry
July 12, 2020
CompletedFirst Posted
Study publicly available on registry
July 21, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
August 30, 2020
CompletedSeptember 30, 2020
September 1, 2020
3 months
July 12, 2020
September 28, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Composite clinical outcome with oxygen therapy dependency time or hospitalization time
Composite clinical outcome with oxygen therapy dependency time (in days) or hospitalization time (in days) after randomization.
1-28 days
Secondary Outcomes (8)
Percentage of participants with adverse events during the use of propolis
1-28 days
Rate and severity of acute kidney injury during the study
1-28 days
Renal replacement therapy.
1-28 days
Rate of need for vasopressor use
1-28 days
Need for intensive care unit (ICU)
1-28 days
- +3 more secondary outcomes
Study Arms (3)
Control
ACTIVE COMPARATORstandard care.
EPP-AF 400mg/day
EXPERIMENTALGreen propolis extract (EPP-AF) at a dose of 400mg / day in addition to the standard treatment.
EPP-AF 800mg/day
EXPERIMENTALGreen propolis extract (EPP-AF) at a dose of 800mg / day in addition to the standard treatment.
Interventions
Green propolis extract (EPP-AF) administered orally or via nasoenteral tube.
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).
Eligibility Criteria
You may qualify if:
- Hospitalized patients;
- Positive RT-PCR for SARS-CoV-2;
- Years and older.
You may not qualify if:
- 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;
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- D'Or Institute for Research and Educationlead
- Hospital Sao Rafaelcollaborator
Study Sites (1)
Hospital Sao Rafael
Salvador, Estado de Bahia, 41820340, Brazil
Related Publications (9)
Hori JI, Zamboni DS, Carrao DB, Goldman GH, Berretta AA. The Inhibition of Inflammasome by Brazilian Propolis (EPP-AF). Evid Based Complement Alternat Med. 2013;2013:418508. doi: 10.1155/2013/418508. Epub 2013 Apr 16.
PMID: 23690844BACKGROUNDSanders JM, Monogue ML, Jodlowski TZ, Cutrell JB. Pharmacologic Treatments for Coronavirus Disease 2019 (COVID-19): A Review. JAMA. 2020 May 12;323(18):1824-1836. doi: 10.1001/jama.2020.6019.
PMID: 32282022RESULTMaruta H, He H. PAK1-blockers: Potential Therapeutics against COVID-19. Med Drug Discov. 2020 Jun;6:100039. doi: 10.1016/j.medidd.2020.100039. Epub 2020 Apr 19.
PMID: 32313880RESULTSerkedjieva J, Manolova N, Bankova V. Anti-influenza virus effect of some propolis constituents and their analogues (esters of substituted cinnamic acids). J Nat Prod. 1992 Mar;55(3):294-302. doi: 10.1021/np50081a003.
PMID: 1593279RESULTHoffmann M, Kleine-Weber H, Schroeder S, Kruger N, Herrler T, Erichsen S, Schiergens TS, Herrler G, Wu NH, Nitsche A, Muller MA, Drosten C, Pohlmann S. SARS-CoV-2 Cell Entry Depends on ACE2 and TMPRSS2 and Is Blocked by a Clinically Proven Protease Inhibitor. Cell. 2020 Apr 16;181(2):271-280.e8. doi: 10.1016/j.cell.2020.02.052. Epub 2020 Mar 5.
PMID: 32142651RESULTMachado JL, Assuncao AK, da Silva MC, Dos Reis AS, Costa GC, Arruda Dde S, Rocha BA, Vaz MM, Paes AM, Guerra RN, Berretta AA, do Nascimento FR. Brazilian green propolis: anti-inflammatory property by an immunomodulatory activity. Evid Based Complement Alternat Med. 2012;2012:157652. doi: 10.1155/2012/157652. Epub 2012 Dec 19.
PMID: 23320022RESULTMani JS, Johnson JB, Steel JC, Broszczak DA, Neilsen PM, Walsh KB, Naiker M. Natural product-derived phytochemicals as potential agents against coronaviruses: A review. Virus Res. 2020 Jul 15;284:197989. doi: 10.1016/j.virusres.2020.197989. Epub 2020 Apr 30.
PMID: 32360300RESULTSilveira MAD, Teles F, Berretta AA, Sanches TR, Rodrigues CE, Seguro AC, Andrade L. Effects of Brazilian green propolis on proteinuria and renal function in patients with chronic kidney disease: a randomized, double-blind, placebo-controlled trial. BMC Nephrol. 2019 Apr 25;20(1):140. doi: 10.1186/s12882-019-1337-7.
PMID: 31023272RESULTCusinato DAC, Martinez EZ, Cintra MTC, Filgueira GCO, Berretta AA, Lanchote VL, Coelho EB. Evaluation of potential herbal-drug interactions of a standardized propolis extract (EPP-AF(R)) using an in vivo cocktail approach. J Ethnopharmacol. 2019 Dec 5;245:112174. doi: 10.1016/j.jep.2019.112174. Epub 2019 Aug 20.
PMID: 31442620RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Marcelo Silveira, MD, PhD
D'Or Institute for Research and Education (IDOR)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- The individual who evaluates the results of interest to the study will not have access to the study steps before the analysis.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
July 12, 2020
First Posted
July 21, 2020
Study Start
June 2, 2020
Primary Completion
August 30, 2020
Study Completion
August 30, 2020
Last Updated
September 30, 2020
Record last verified: 2020-09