AzTrials
AzTrials

Covid19Phase 2/3Bee-CovidNCT04480593

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

A Phase 2/3 study testing Brazilian Green Propolis Extract (EPP-AF) in people with Covid19, run by D'Or Institute for Research and Education at 1 site in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Covid19
What is being tested?
Brazilian Green Propolis Extract (EPP-AF)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
1 siteBrazil
Study dates
2 Jun 2020to 30 Aug 2020
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Hospitalized patients;
  • Positive RT-PCR for SARS-CoV-2;
  • 18 Years and older.

Who cannot join

  • 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;
Show all 10Show fewer
  • 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;

Trial locations and contacts

1 site in 1 country.

Brazil1 site

  • Hospital Sao Rafael

    Salvador, Estado de Bahia, 41820340

Other trials in Brazil

About this study

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

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.

Conditions
Covid19
Being tested
Brazilian Green Propolis Extract (EPP-AF), Standard care
Keywords
Propolis, Covid19, SARS-CoV-2, Anti-inflammatory
Medical subject headings
COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Brazilian Green Propolis Extract (EPP-AF)Drug

    Also called Standard care

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

  • Standard careOther

    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).

Study groups in NCT04480593
Study groupRoleWhat they receive
ControlActive comparatorstandard care.
Receives: Other: Standard care
EPP-AF 400mg/dayExperimentalGreen propolis extract (EPP-AF) at a dose of 400mg / day in addition to the standard treatment.
Receives: Drug: Brazilian Green Propolis Extract (EPP-AF)
EPP-AF 800mg/dayExperimentalGreen propolis extract (EPP-AF) at a dose of 800mg / day in addition to the standard treatment.
Receives: Drug: Brazilian Green Propolis Extract (EPP-AF)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Composite clinical outcome with oxygen therapy dependency time or hospitalization time

    Composite clinical outcome with oxygen therapy dependency time (in days) or hospitalization time (in days) after randomization.

    Measured: 1-28 days

Secondary outcomes (8)

  1. Percentage of participants with adverse events during the use of propolis

    We will evaluate the presence or absence of symptoms related to the use of propolis through a questionnaire.

    Measured: 1-28 days

  2. Rate and severity of acute kidney injury during the study

    Assess the degree of acute kidney injury according to KDIGO (through serum creatinine or urine output).

    Measured: 1-28 days

  3. Renal replacement therapy.

    Assess need or not for renal replacement therapy.

    Measured: 1-28 days

  4. Rate of need for vasopressor use

    Describe the time needed for vasopressors in days after randomization

    Measured: 1-28 days

  5. Need for intensive care unit (ICU)

    Assess length of stay in the ICU after randomization in days

    Measured: 1-28 days

  6. Intensive care unit (ICU) readmission

    Rate of readmission to the ICU after randomization

    Measured: 1-28 days

  7. Invasive oxygenation time

    Assess the need for mechanical ventilation in days after randomization.

    Measured: 1-28 days

  8. Variation of plasma c-reactive protein

    Evaluate the variation in serum levels of c-reactive protein over the 7 days after randomization

    Measured: 1-7 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Jul 2020
  2. Study start2 Jun 2020
  3. Primary completion30 Aug 2020
  4. Study completion30 Aug 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
three parallel groups randomly assigned
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
120 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04480593
Sponsor's protocol ID
31099320.6.0000.0048
Acronym
Bee-Covid
Status last verified
Sep 2020
First submitted
12 Jul 2020
Last updated
30 Sep 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Hori JI, Zamboni DS, Carrao DB, Goldman GH, Berretta AA. The Inhibition of Inflammasome by Brazilian Propolis (EPP-AF). Evid Based Complement Alternat Med. 2013;2013:418508. doi: 10.1155/2013/418508. Epub 2013 Apr 16.

    PubMed 23690844

  • Sanders JM, Monogue ML, Jodlowski TZ, Cutrell JB. Pharmacologic Treatments for Coronavirus Disease 2019 (COVID-19): A Review. JAMA. 2020 May 12;323(18):1824-1836. doi: 10.1001/jama.2020.6019.

    PubMed 32282022

  • Maruta H, He H. PAK1-blockers: Potential Therapeutics against COVID-19. Med Drug Discov. 2020 Jun;6:100039. doi: 10.1016/j.medidd.2020.100039. Epub 2020 Apr 19.

    PubMed 32313880

  • Serkedjieva J, Manolova N, Bankova V. Anti-influenza virus effect of some propolis constituents and their analogues (esters of substituted cinnamic acids). J Nat Prod. 1992 Mar;55(3):294-302. doi: 10.1021/np50081a003.

    PubMed 1593279

  • Hoffmann M, Kleine-Weber H, Schroeder S, Kruger N, Herrler T, Erichsen S, Schiergens TS, Herrler G, Wu NH, Nitsche A, Muller MA, Drosten C, Pohlmann S. SARS-CoV-2 Cell Entry Depends on ACE2 and TMPRSS2 and Is Blocked by a Clinically Proven Protease Inhibitor. Cell. 2020 Apr 16;181(2):271-280.e8. doi: 10.1016/j.cell.2020.02.052. Epub 2020 Mar 5.

    PubMed 32142651

  • Machado JL, Assuncao AK, da Silva MC, Dos Reis AS, Costa GC, Arruda Dde S, Rocha BA, Vaz MM, Paes AM, Guerra RN, Berretta AA, do Nascimento FR. Brazilian green propolis: anti-inflammatory property by an immunomodulatory activity. Evid Based Complement Alternat Med. 2012;2012:157652. doi: 10.1155/2012/157652. Epub 2012 Dec 19.

    PubMed 23320022

  • Mani JS, Johnson JB, Steel JC, Broszczak DA, Neilsen PM, Walsh KB, Naiker M. Natural product-derived phytochemicals as potential agents against coronaviruses: A review. Virus Res. 2020 Jul 15;284:197989. doi: 10.1016/j.virusres.2020.197989. Epub 2020 Apr 30.

    PubMed 32360300

  • Silveira MAD, Teles F, Berretta AA, Sanches TR, Rodrigues CE, Seguro AC, Andrade L. Effects of Brazilian green propolis on proteinuria and renal function in patients with chronic kidney disease: a randomized, double-blind, placebo-controlled trial. BMC Nephrol. 2019 Apr 25;20(1):140. doi: 10.1186/s12882-019-1337-7.

    PubMed 31023272

  • Cusinato DAC, Martinez EZ, Cintra MTC, Filgueira GCO, Berretta AA, Lanchote VL, Coelho EB. Evaluation of potential herbal-drug interactions of a standardized propolis extract (EPP-AF(R)) using an in vivo cocktail approach. J Ethnopharmacol. 2019 Dec 5;245:112174. doi: 10.1016/j.jep.2019.112174. Epub 2019 Aug 20.

    PubMed 31442620

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Brazilian Green Propolis Extract (EPP-AF) in people with Covid19, run by D'Or Institute for Research and Education at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Composite clinical outcome with oxygen therapy dependency time or hospitalization time (time frame: 1-28 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04480593, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2020.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in