Covid19NCT05037240
Quercetin in the Prevention of Covid-19 Infection
A study testing Quercetin in people with Covid19, run by Azienda di Servizi alla Persona di Pavia at 1 site in Italy.
Trial summary
Quercetin is a flavonol, a subclass of flavonoid compounds. Of the flavonol molecules, quercetin is the most abundant in fruit and vegetables. Quercetin flavonol is characterized by 3 crucial properties: antioxidant, anti-inflammatory and immunomodulatory. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Covid19
- What is being tested?
- Quercetin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteItaly
- Study dates
- 12 Jan 2021to 25 May 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Absence of Covid-19 infection
Who cannot join
- Previous Sars-Cov-2 infection demonstrated with antibody positivity through venous sampling
- Demonstrated presence of Sars-Cov-2 through a nasopharyngeal antigenic swab before the start of oral nutritional supplementation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized, Placebo-controlled Clinical Trial to Evaluate the Efficacy of an Oral Nutritional Supplement Based on Quercetin in the Prevention of Covid-19 Infection for a Duration of 3 Months
Quercetin is a flavonol, a subclass of flavonoid compounds. Of the flavonol molecules, quercetin is the most abundant in fruit and vegetables. Quercetin flavonol is characterized by 3 crucial properties: antioxidant, anti-inflammatory and immunomodulatory. The combination of these 3 properties makes quercetin an excellent candidate for dealing with situations in which oxidative stress, inflammation and the immune system are involved. The purpose of the study is to evaluate the effectiveness of an oral nutritional supplement based on quercetin in the prevention of Covid-19 infection.
- Conditions
- Covid19
- Being tested
- Quercetin, Placebo
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuercetinDietary supplement
Quercetin (500 mg), 2 times a day for 3 months
PlaceboCombination product
500 mg, 2 times a day for 3 months
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Active comparator | Not described Receives: Dietary Supplement: Quercetin |
| Placebo | Placebo comparator | Not described Receives: Combination Product: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevention of Covid-19 infection
A nasopharyngeal antigenic swab
Measured: Absence of Covid-19 infection at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2021
- Study start12 Jan 2021
- Primary completion6 Apr 2021
- Study completion25 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda di Servizi alla Persona di Pavia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05037240
- Sponsor's protocol ID
- 1222/01022021
- Status last verified
- Sep 2021
- First submitted
- 3 Sep 2021
- Last updated
- 8 Sep 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Placebo-controlled Clinical Trial to Evaluate the Efficacy of an Oral Nutritional Supplement Based on Quercetin in the Prevention of Covid-19 Infection for a Duration of 3 Months
- ClinicalTrials.gov ID
- NCT05037240
- Acronym / sponsor ID
- 1222/01022021
- Conditions
- Covid19
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Azienda di Servizi alla Persona di PaviaUniversity, hospital or other
- Study start
- 12 Jan 2021 (actual)
- Primary completion
- 6 Apr 2021 (actual)
- Study completion
- 25 May 2021 (actual)
- First posted
- 8 Sep 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.
Quercetin is a flavonol, a subclass of flavonoid compounds. Of the flavonol molecules, quercetin is the most abundant in fruit and vegetables. Quercetin flavonol is characterized by 3 crucial properties: antioxidant, anti-inflammatory and immunomodulatory. The combination of these 3 properties makes quercetin an excellent candidate for dealing with situations in which oxidative stress, inflammation and the immune system are involved. The purpose of the study is to evaluate the effectiveness of an oral nutritional supplement based on quercetin in the prevention of Covid-19 infection.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Active comparator | Dietary Supplement: Quercetin |
| Placebo | Placebo comparator | Combination Product: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Absence of Covid-19 infection
Key exclusion criteria (2 listed)
- Previous Sars-Cov-2 infection demonstrated with antibody positivity through venous sampling
- Demonstrated presence of Sars-Cov-2 through a nasopharyngeal antigenic swab before the start of oral nutritional supplementation
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 |
|---|---|---|
| QuercetinQuercetin (500 mg), 2 times a day for 3 months | Dietary supplement | Intervention Group |
| Placebo500 mg, 2 times a day for 3 months | Combination product | Placebo |
Primary outcome
Prevention of Covid-19 infection
Time frame: Absence of Covid-19 infection at 3 months
A nasopharyngeal antigenic swab
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2021.
Related trials for Covid19
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Quercetin in people with Covid19, run by Azienda di Servizi alla Persona di Pavia at 1 site in Italy.
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 1 inclusion and 2 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 8 Sep 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 Italy. 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. Some participants in this study may receive a placebo. 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?
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?
Prevention of Covid-19 infection (time frame: Absence of Covid-19 infection at 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Sep 2021.