Covid19, Inflammation
Conditions
Keywords
Propolis, Covid19, Anti-Inflammatory Agents, Immunoregulation
Brief summary
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) promotes challenging immune and inflammatory phenomena. Though various therapeutic possibilities have been tested against coronavirus disease 2019 (COVID-19), the most adequate treatment has not yet been established. Among candidate adjunct treatment options, propolis, produced by honey bees from bioactive plant exudates, has shown potential against viral targets and has demonstrated immunoregulatory properties.
Detailed description
To evaluate the efficacy and safety of oral propolis as an adjunct treatment for SARS-CoV-2 infection, we designed a randomized, double-blind, placebo-controlled trial (Bee-Covid2) (The Use of Brazilian Green Propolis Extract (EPP-AF®) in Patients Affected by COVID-19).
Interventions
DRUGStandardized Brazilian Green Propolis Extract
900mg/day of Standardized Brazilian Green Propolis Extract for 10 days.
DRUGPlacebo
900mg/day of Placebo for 10 days.
Sponsors
Apis Flora Industrial e Comercial Ltda
D'Or Institute for Research and Education
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
The capsules will be coated, in opaque and equal packaging, so that the researchers involved in the care of patients could not distinguish between propolis and placebo. Neither the participants, nor the principal investigator, nor the health professionals involved in the care will know which group the patients will be allocated.
Intervention model description
A randomized, double-blind, placebo-controlled trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Older than 18 years; * Diagnosis of coronavirus infection confirmed by polymerase chain reaction - reverse transcriptase testing; * Symptoms started within 14 days of the randomization date
Exclusion criteria
* Pregnant or lactating women; * Known hypersensitivity to propolis; * Propolis use less than 30 days from the randomization date; * Active cancer; * Human immunodeficiency virus carriers; * Patients undergoing transplantation of solid organs or bone marrow or who were using immunosuppressive medications; * Bacterial infection at randomization, sepsis or septic shock related to bacterial infection at randomization; * Impossibility of using the medication orally or by nasoenteral tube; * Known hepatic failure or advanced heart failure (New York Heart Association \[NYHA\] class III or IV). * End Stage Renal Disease (ESRD).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Length of hospital stay | 1-28 days | Hospitalization time after randomization (in days) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of participants with adverse events during the use of propolis or placebo | 1-28 days | We will evaluate the presence or absence of symptoms related to the use of propolis or placebo. |
| Rate and severity of acute kidney injury during the study | 1-28 days | Assess the degree of acute kidney injury according to KDIGO. |
| 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. |
| Invasive oxygenation time | 1-28 days | Assess the need for mechanical ventilation in days after randomization. |
| Need for Intra-Aortic Balloon Pump | 1-28 days | Assess the need for Intra-Aortic Balloon Pump in days after randomization. |
| Need for Extracorporeal Oxygenation Membrane (ECMO) | 1-28 days | Assess the need for Extracorporeal Oxygenation Membrane in days after randomization. |
| Intensive care unit (ICU) readmission | 1-28 days | Rate of readmission to the ICU after randomization |
Other
| Measure | Time frame | Description |
|---|---|---|
| Death | 1-28 days | Assess mortality rate |
Countries
Brazil
Outcome results
None listed