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

Sponsor

D'Or Institute for Research and Education (Other)

Overall Status

Completed

CT.gov ID

NCT04480593

Collaborator

Hospital Sao Rafael (Other)

120

Enrollment

Location

Arms

2.9

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Covid19	Drug: Brazilian Green Propolis Extract (EPP-AF) Other: Standard care	Phase 2/Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

three parallel groups randomly assignedthree parallel groups randomly assigned

Masking:

Single (Outcomes Assessor)

Masking Description:

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

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jun 2, 2020

Actual Primary Completion Date :

Aug 30, 2020

Actual Study Completion Date :

Aug 30, 2020

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Control 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).
Experimental: EPP-AF 400mg/day Green propolis extract (EPP-AF) at a dose of 400mg / day in addition to the standard treatment.	Drug: Brazilian Green Propolis Extract (EPP-AF) Green propolis extract (EPP-AF) administered orally or via nasoenteral tube. Other Names: Standard care
Experimental: EPP-AF 800mg/day Green propolis extract (EPP-AF) at a dose of 800mg / day in addition to the standard treatment.	Drug: Brazilian Green Propolis Extract (EPP-AF) Green propolis extract (EPP-AF) administered orally or via nasoenteral tube. Other Names: Standard care

Arm

Intervention/Treatment

Active Comparator: Control

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).

Experimental: EPP-AF 400mg/day

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

Drug: Brazilian Green Propolis Extract (EPP-AF)

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

Other Names:

Standard care

Experimental: EPP-AF 800mg/day

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

Drug: Brazilian Green Propolis Extract (EPP-AF)

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

Other Names:

Standard care

Outcome Measures

Primary Outcome Measures

Composite clinical outcome with oxygen therapy dependency time or hospitalization time [1-28 days]
Composite clinical outcome with oxygen therapy dependency time (in days) or hospitalization time (in days) after randomization.

Secondary Outcome Measures

Percentage of participants with adverse events during the use of propolis [1-28 days]
We will evaluate the presence or absence of symptoms related to the use of propolis through a questionnaire.
Rate and severity of acute kidney injury during the study [1-28 days]
Assess the degree of acute kidney injury according to KDIGO (through serum creatinine or urine output).
Renal replacement therapy. [1-28 days]
Assess need or not for renal replacement therapy.
Rate of need for vasopressor use [1-28 days]
Describe the time needed for vasopressors in days after randomization
Need for intensive care unit (ICU) [1-28 days]
Assess length of stay in the ICU after randomization in days
Intensive care unit (ICU) readmission [1-28 days]
Rate of readmission to the ICU after randomization
Invasive oxygenation time [1-28 days]
Assess the need for mechanical ventilation in days after randomization.
Variation of plasma c-reactive protein [1-7 days]
Evaluate the variation in serum levels of c-reactive protein over the 7 days after randomization

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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;