Trial | NCT04480593  Report issue

Title

The Use of Brazilian Green Propolis Extract (EPP-AF) in Patients Affected by COVID-19.
The Use of Brazilian Green Propolis Extract (EPP-AF) in Patients Affected by COVID-19: a Randomized, Open and Pilot Clinical Study.

  • Phase

    Phase 2/Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    120
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.
Study Started
Jun 02
2020
Primary Completion
Aug 30
2020
Study Completion
Aug 30
2020
Last Update
Sep 30
2020

Drug Brazilian Green Propolis Extract (EPP-AF)

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

  • Other names: 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).

EPP-AF 800mg/day Experimental

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

Control Active Comparator

standard care.

EPP-AF 400mg/day Experimental

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

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;
No Results Posted