NCT04480593: Bee-Covid

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

Completed Phase 2, PHASE3 Last updated 30 September 2020

What this trial tests

Phase 2, PHASE3 trial testing Brazilian Green Propolis Extract (EPP-AF) in Covid19 in 120 participants. Completed in 30 August 2020.

Timeline

2 June 2020

Primary endpoint
30 August 2020

30 August 2020

Quick facts

Lead sponsor	D'Or Institute for Research and Education
Phase	Phase 2, PHASE3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	120
Start date	2 June 2020
Primary completion	30 August 2020
Estimated completion	30 August 2020
Sites	1 location across Brazil

Drugs / interventions tested

• Brazilian Green Propolis Extract (EPP-AF) — full drug profile →
• Standard care — full drug profile →

Conditions studied

• Covid19 — all drugs for Covid19 →

Sponsor

D'Or Institute for Research and Education

Who can join

18 and older, any sex, with Covid19. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. An update on drugs with therapeutic potential for SARS-CoV-2 (COVID-19) treatment.
   Drożdżal S, Rosik J, Lechowicz K, Machaj F, et al · · 2021 · cited 186× · PMID 34991982 · DOI 10.1016/j.drup.2021.100794
2. Propolis and its potential against SARS-CoV-2 infection mechanisms and COVID-19 disease: Running title: Propolis against SARS-CoV-2 infection and COVID-19.
   Berretta AA, Silveira MAD, Cóndor Capcha JM, De Jong D. · · 2020 · cited 138× · PMID 32890967 · DOI 10.1016/j.biopha.2020.110622
3. Efficacy of Brazilian green propolis (EPP-AF®) as an adjunct treatment for hospitalized COVID-19 patients: A randomized, controlled clinical trial.
   Silveira MAD, De Jong D, Berretta AA, Galvão EBDS, et al · · 2021 · cited 72× · PMID 34311528 · DOI 10.1016/j.biopha.2021.111526
4. Bee products as a source of promising therapeutic and chemoprophylaxis strategies against COVID-19 (SARS-CoV-2).
   Lima WG, Brito JCM, da Cruz Nizer WS. · · 2021 · cited 65× · PMID 32945590 · DOI 10.1002/ptr.6872
5. Traditional Herbal Medicines, Bioactive Metabolites, and Plant Products Against COVID-19: Update on Clinical Trials and Mechanism of Actions.
   Alam S, Sarker MMR, Afrin S, Richi FT, et al · · 2021 · cited 61× · PMID 34122096 · DOI 10.3389/fphar.2021.671498
6. Association of COVID-19 with Comorbidities: An Update.
   Chatterjee S, Nalla LV, Sharma M, Sharma N, et al · · 2023 · cited 60× · PMID 36923110 · DOI 10.1021/acsptsci.2c00181
7. Anti-Viral and Immunomodulatory Properties of Propolis: Chemical Diversity, Pharmacological Properties, Preclinical and Clinical Applications, and In Silico Potential against SARS-CoV-2.
   Yosri N, Abd El-Wahed AA, Ghonaim R, Khattab OM, et al · · 2021 · cited 54× · PMID 34441553 · DOI 10.3390/foods10081776
8. Pulmonary fibrosis from molecular mechanisms to therapeutic interventions: lessons from post-COVID-19 patients.
   Giacomelli C, Piccarducci R, Marchetti L, Romei C, et al · · 2021 · cited 48× · PMID 34687672 · DOI 10.1016/j.bcp.2021.114812