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

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StatusRekrutacyjny

Sponsorzy

D'Or Institute for Research and Education

Współpracownicy

Hospital Sao Rafael

BADANIE KLINICZNE: NCT04480593

BioSeek: nct04480593

Słowa kluczowe

Abstrakcyjny

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.

Daktyle

Ostatnia weryfikacja:	06/30/2020
Pierwsze przesłane:	07/11/2020
Szacowana liczba przesłanych rejestracji:	07/19/2020
Wysłany pierwszy:	07/20/2020
Ostatnia aktualizacja przesłana:	07/19/2020
Ostatnia opublikowana aktualizacja:	07/20/2020
Rzeczywista data rozpoczęcia badania:	06/01/2020
Szacowana data zakończenia podstawowej działalności:	08/14/2020
Szacowana data zakończenia badania:	08/29/2020

Stan lub choroba

Covid19

Interwencja / leczenie

Drug: Brazilian Green Propolis Extract (EPP-AF)

Other: Control

Faza

Faza 2/Faza 3

Grupy ramion

Ramię	Interwencja / leczenie
Active Comparator: Control standard care.	Other: Control 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.
Experimental: EPP-AF 800mg/day Green propolis extract (EPP-AF) at a dose of 800mg / day in addition to the standard treatment.

Kryteria kwalifikacji

Wiek kwalifikujący się do nauki	18 Years Do 18 Years
Płeć kwalifikująca się do nauki	All
Przyjmuje zdrowych wolontariuszy	tak
Kryteria	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;

Wynik

Podstawowe miary wyników

1. 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.

Miary wyników wtórnych

1. 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.

2. 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).

3. Renal replacement therapy. [1-28 days]

Assess need or not for renal replacement therapy.

4. Rate of need for vasopressor use [1-28 days]

Describe the time needed for vasopressors in days after randomization

5. Need for intensive care unit (ICU) [1-28 days]

Assess length of stay in the ICU after randomization in days

6. Intensive care unit (ICU) readmission [1-28 days]

Rate of readmission to the ICU after randomization

7. Invasive oxygenation time [1-28 days]

Assess the need for mechanical ventilation in days after randomization.

8. 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

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

Słowa kluczowe

covid-19

resin

coronavirus infections

zapalenie

anti inflammatoire

przeciwutleniacz

lek przeciwwirusowy