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

Completed
COVID19

Drug: Brazilian Green Propolis Extract (EPP-AF)

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

Eligibility 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;

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
Brazil
Locations

Hospital Sao Rafael
Salvador, BA, Brazil

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

Hospital Sao Rafael
NCT Number
Keywords
Propolis
COVID19
SARS-CoV-2
Anti-inflammatory
MeSH Terms
COVID-19
Propolis