SARS-CoV2 InfectionNCT04916821
Investigation of Clinical Effectiveness of Propolis Extracts as Food Supplements in Patients With SARS-CoV-2(COVID-19)
A study testing propolis in people with SARS-CoV2 Infection, run by Trabzon Kanuni Education and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Primary purpose: To investigate the effect of propolis, a food supplement product, on healing parameters in patients with COVID 19. Secondary purpose: To provide a new supportive treatment in Covid 19 treatment. Read more about this study
- Who is it for?
- Ages 18 to 59 yearsHealthy volunteers can take part
- Conditions the study is for
- SARS-CoV2 Infection
- What is being tested?
- propolis
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 May 2021to 15 Aug 2021
- Phase
- Interventional
- 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 to 59 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients over the age of 18 who do not need a ventilator who are inpatient in the Covid service
- Patients under the age of 60 who do not need a ventilator who are inpatient in the Covid service
Who cannot join
- patients do not have oral intake
- patients whose informed consent form is not approved
- patients who need a ventilator
- pregnant women
- children
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Trabzon Faculty of Medicine , Health Science University
Trabzon, 61080
About this study
Primary purpose: To investigate the effect of propolis, a food supplement product, on healing parameters in patients with COVID 19. Secondary purpose: To provide a new supportive treatment in Covid 19 treatment. In the present study to examine the effect of the use of propolis on healing parameters (laboratory and imaging) in patients with COVID 19; Propolis, which has antiviral properties, has also been used in humans in the COVID19 pandemic as of 2020. However, in these studies, an alcohol-soluble extract of propolis was used. Despite the disadvantages of its use in alcohol, it is clear that water and olive oil extracts of Propolis are safer for humans. Therefore, water extracts of propolis will be used in the study.
- Conditions
- SARS-CoV2 Infection
- Being tested
- propolis
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
propolisDietary supplement
Propolis may be blocked virus entry to cells, and some receptor binding and some cell signal molecules
| Study group | Role | What they receive |
|---|---|---|
| water extract of propolis | Experimental | Patients given 2 ml of aqueous propolis extract (50mg / ml) orally 3 times a day for 1 week Receives: Dietary Supplement: propolis |
| olive oil extract of propolis including perga | Experimental | Patients given 1 ml oily propolis extract (64 mg / ml) + 1 ml oily perga extract (120 mg / ml) orally 3 times a day for 1 week Receives: Dietary Supplement: propolis |
| control | No intervention | control group (patients not given any investigational product) |
What is being measured
The primary outcome is the main question the study is designed to answer.
radiological
Lung tomography findings
Measured: Change from Baseline Lung Tomography Findings(Peripheral ground-glass opacities) at one week
laboratory parameters-2: ESR
ESR
Measured: Change from Baseline ESR findings at one week
laboratory parameters-3: CRP
CRP
Measured: Change from Baseline CRP findings at one week
laboratory parameters-4: D-Dimer
D-Dimer
Measured: Change from Baseline D-Dimer findings at one week
laboratory parameters-5: Troponin
Troponin
Measured: Change from Baseline Troponin findings at one week
laboratory parameters-6: sO2
sO2
Measured: Change from Baseline sO2 findings at one week
laboratory parameters-1: CBC
CBC
Measured: Change from Baseline CBC findings at one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2021
- Study start15 May 2021
- Primary completion15 Jul 2021 (estimated)
- Study completion15 Aug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for SARS-CoV2 InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- first group treated with water extracts of propolis second group treated with olive oil extracts of propolis including perga third group treated with no bee product
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Trabzon Kanuni Education and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Betül Değer Kulaksız, Trabzon Kanuni Education and Research Hospital
- Investigators
- Betül Değer Kulaksız, M.D, Study chair, Trabzon Kanuni Education and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04916821
- Sponsor's protocol ID
- 00001
- Status last verified
- Jun 2021
- First submitted
- 26 May 2021
- Last updated
- 8 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared.
Publications
Berretta AA, Silveira MAD, Condor Capcha JM, De Jong D. 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. Biomed Pharmacother. 2020 Nov;131:110622. doi: 10.1016/j.biopha.2020.110622. Epub 2020 Aug 17.
PubMed 32890967Lima WG, Brito JCM, da Cruz Nizer WS. Bee products as a source of promising therapeutic and chemoprophylaxis strategies against COVID-19 (SARS-CoV-2). Phytother Res. 2021 Feb;35(2):743-750. doi: 10.1002/ptr.6872. Epub 2020 Sep 18.
PubMed 32945590
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Clinical Effectiveness of Propolis Extracts as Food Supplements in Patients With SARS-CoV-2(COVID-19)
- ClinicalTrials.gov ID
- NCT04916821
- Acronym / sponsor ID
- 00001
- Conditions
- SARS-CoV2 Infection
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Trabzon Kanuni Education and Research HospitalUniversity, hospital or other
- Study start
- 15 May 2021 (actual)
- Primary completion
- 15 Jul 2021 (estimated)
- Study completion
- 15 Aug 2021 (estimated)
- First posted
- 8 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Primary purpose: To investigate the effect of propolis, a food supplement product, on healing parameters in patients with COVID 19. Secondary purpose: To provide a new supportive treatment in Covid 19 treatment. In the present study to examine the effect of the use of propolis on healing parameters (laboratory and imaging) in patients with COVID 19; Propolis, which has antiviral properties, has also been used in humans in the COVID19 pandemic as of 2020. However, in these studies, an alcohol-soluble extract of propolis was used. Despite the disadvantages of its use in alcohol, it is clear that water and olive oil extracts of Propolis are safer for humans. Therefore, water extracts of propolis will be used in the study.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- first group treated with water extracts of propolis second group treated with olive oil extracts of propolis including perga third group treated with no bee product
| Arm | Type | Receives |
|---|---|---|
| water extract of propolis | Experimental | Dietary Supplement: propolisPatients given 2 ml of aqueous propolis extract (50mg / ml) orally 3 times a day for 1 week |
| olive oil extract of propolis including perga | Experimental | Dietary Supplement: propolisPatients given 1 ml oily propolis extract (64 mg / ml) + 1 ml oily perga extract (120 mg / ml) orally 3 times a day for 1 week |
| control | No intervention | –control group (patients not given any investigational product) |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Patients over the age of 18 who do not need a ventilator who are inpatient in the Covid service
- Patients under the age of 60 who do not need a ventilator who are inpatient in the Covid service
Key exclusion criteria (5 listed)
- patients do not have oral intake
- patients whose informed consent form is not approved
- patients who need a ventilator
- pregnant women
- children
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| propolisPropolis may be blocked virus entry to cells, and some receptor binding and some cell signal molecules | Dietary supplement | olive oil extract of propolis including perga, water extract of propolis |
Primary outcome
radiological
Time frame: Change from Baseline Lung Tomography Findings(Peripheral ground-glass opacities) at one week
Lung tomography findings
laboratory parameters-2: ESR
Time frame: Change from Baseline ESR findings at one week
ESR
laboratory parameters-3: CRP
Time frame: Change from Baseline CRP findings at one week
CRP
laboratory parameters-4: D-Dimer
Time frame: Change from Baseline D-Dimer findings at one week
D-Dimer
laboratory parameters-5: Troponin
Time frame: Change from Baseline Troponin findings at one week
Troponin
laboratory parameters-6: sO2
Time frame: Change from Baseline sO2 findings at one week
sO2
laboratory parameters-1: CBC
Time frame: Change from Baseline CBC findings at one week
CBC
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2021.
- Background: PubMed 32890967Berretta AA, Silveira MAD, Condor Capcha JM, De Jong D. 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. Biomed Pharmacother. 2020 Nov;131:110622. doi: 10.1016/j.biopha.2020.110622. Epub 2020 Aug 17.
- Background: PubMed 32945590Lima WG, Brito JCM, da Cruz Nizer WS. Bee products as a source of promising therapeutic and chemoprophylaxis strategies against COVID-19 (SARS-CoV-2). Phytother Res. 2021 Feb;35(2):743-750. doi: 10.1002/ptr.6872. Epub 2020 Sep 18.
- Individual participant dataSharing planned: No. Individual participant data will not be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Betül Değer Kulaksız, M.D study chair
Trabzon Kanuni Education and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing propolis in people with SARS-CoV2 Infection, run by Trabzon Kanuni Education and Research Hospital at 1 site in Turkey (Türkiye).
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 2 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 8 Jun 2021. 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 Turkey (Türkiye). 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.
Are results available for this study?
Results are not available in the source record.
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?
radiological (time frame: Change from Baseline Lung Tomography Findings(Peripheral ground-glass opacities) at one week). The study lists 7 primary outcomes in all. 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 NCT04916821, which also lists 2 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 8 Jun 2021.