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

NCT04480593 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2020-09-30

No results posted yet for this study

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.

Conditions

  • Covid19

Interventions

DRUG

Brazilian Green Propolis Extract (EPP-AF)

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

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).

Sponsors & Collaborators

  • Hospital Sao Rafael

    collaborator OTHER

  • D'Or Institute for Research and Education

    lead OTHER

Principal Investigators

  • Marcelo Silveira, MD, PhD · D'Or Institute for Research and Education (IDOR)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-02
Primary Completion
2020-08-30
Completion
2020-08-30

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04480593 on ClinicalTrials.gov