Covid19
Conditions
Keywords
Propolis, Covid19, SARS-CoV-2, Anti-inflammatory
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.
Interventions
DRUGBrazilian Green Propolis Extract (EPP-AF)
Green propolis extract (EPP-AF) administered orally or via nasoenteral tube.
OTHERStandard 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
Hospital Sao Rafael
D'Or Institute for Research and Education
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
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.
Intervention model description
three parallel groups randomly assigned
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Brazil
Outcome results
None listed