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

Phase 2

Completed

• Conditions: Covid19
• Interventions: Other: Standard care; Drug: Brazilian Green Propolis Extract (EPP-AF)

• Registration Number: NCT04480593
• Lead Sponsor: D'Or Institute for Research and Education

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-06-02
• Study First Submitted: 2020-07-12
• Study First Submitted QC: 2020-07-20
• Study First Posted: 2020-07-21
• Primary Completion: 2020-08-30
• Study Completion: 2020-08-30
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-28
• Last Update Posted: 2020-09-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Standard care	standard care.
EPP-AF 400mg/day	Brazilian Green Propolis Extract (EPP-AF)	Green propolis extract (EPP-AF) at a dose of 400mg / day in addition to the standard treatment.
EPP-AF 800mg/day	Brazilian Green Propolis Extract (EPP-AF)	Green propolis extract (EPP-AF) at a dose of 800mg / day in addition to the standard treatment.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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).
Rate of need for vasopressor use	1-28 days	Describe the time needed for vasopressors in days after randomization
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
Renal replacement therapy.	1-28 days	Assess need or not for renal replacement therapy.
Need for intensive care unit (ICU)	1-28 days	Assess length of stay in the ICU after randomization in days

Trial Locations

Locations (1)

Hospital Sao Rafael; 🇧🇷 Salvador, BA, Brazil