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

NCT ID: NCT04480593

Last Updated: 2020-09-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-02

Study Completion Date

2020-08-30

Brief Summary

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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.

Detailed Description

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Conditions

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Covid19

Keywords

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Propolis Covid19 SARS-CoV-2 Anti-inflammatory

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

three parallel groups randomly assigned
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
The individual who evaluates the results of interest to the study will not have access to the study steps before the analysis.

Study Groups

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Control

standard care.

Group Type ACTIVE_COMPARATOR

Standard care

Intervention Type 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).

EPP-AF 400mg/day

Green propolis extract (EPP-AF) at a dose of 400mg / day in addition to the standard treatment.

Group Type EXPERIMENTAL

Brazilian Green Propolis Extract (EPP-AF)

Intervention Type DRUG

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

EPP-AF 800mg/day

Green propolis extract (EPP-AF) at a dose of 800mg / day in addition to the standard treatment.

Group Type EXPERIMENTAL

Brazilian Green Propolis Extract (EPP-AF)

Intervention Type DRUG

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

Interventions

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Brazilian Green Propolis Extract (EPP-AF)

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

Intervention Type DRUG

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).

Intervention Type OTHER

Other Intervention Names

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Standard care

Eligibility Criteria

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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;
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital Sao Rafael

OTHER

Sponsor Role collaborator

D'Or Institute for Research and Education

OTHER

Sponsor Role lead

Responsible Party

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Marcelo Silveira

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Marcelo Silveira, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

D'Or Institute for Research and Education (IDOR)

Locations

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Hospital Sao Rafael

Salvador, Estado de Bahia, Brazil

Site Status

Countries

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Brazil

References

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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.

Reference Type BACKGROUND
PMID: 23690844 (View on PubMed)

Sanders 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.

Reference Type RESULT
PMID: 32282022 (View on PubMed)

Maruta 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.

Reference Type RESULT
PMID: 32313880 (View on PubMed)

Serkedjieva 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.

Reference Type RESULT
PMID: 1593279 (View on PubMed)

Hoffmann 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.

Reference Type RESULT
PMID: 32142651 (View on PubMed)

Machado 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.

Reference Type RESULT
PMID: 23320022 (View on PubMed)

Mani 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.

Reference Type RESULT
PMID: 32360300 (View on PubMed)

Silveira 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.

Reference Type RESULT
PMID: 31023272 (View on PubMed)

Cusinato 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.

Reference Type RESULT
PMID: 31442620 (View on PubMed)

Other Identifiers

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31099320.6.0000.0048

Identifier Type: -

Identifier Source: org_study_id