COVID-19NCT04377789
Effect of Quercetin on Prophylaxis and Treatment of COVID-19
A study testing Quercetin Prophylaxis and Quercetin Treatment in people with COVID-19, run by Kanuni Sultan Suleyman Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Novel Coronavirus is defined to be the cause of COVID-19, recently. It's known that COVID-19 goes with excessive immune reaction of human body in severe cases. The investigators hypothesize that quercetin, as a strong scavenger and anti-inflammatory agent, can be effective on both prophylaxis and treatment of COVID-19… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- COVID-19
- What is being tested?
- Quercetin Prophylaxis and Quercetin Treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 447 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Mar 2020to 31 Aug 2020
- 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
- moderate-high risk for COVID-19
- obtained informed consent
Who cannot join
- declined to participate
- genetic/chromosomal abnormalities
- any kind of sensitivity or allergy for quercetin
- history of previous hypersensitivity with quercetin
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kanuni Sultan Suleyman Training and Research Hospital
Istanbul, 34303
About this study
Official title: The Possible Effect of Quercetin on Prophylaxis and Treatment of COVID-19
Novel Coronavirus is defined to be the cause of COVID-19, recently. It's known that COVID-19 goes with excessive immune reaction of human body in severe cases. The investigators hypothesize that quercetin, as a strong scavenger and anti-inflammatory agent, can be effective on both prophylaxis and treatment of COVID-19 cases. Therefore, the aim of this study to evaluate the possible role of quercetin on prophylaxis and treatment of COVID-19.
Read the detailed description
Novel Coronavirus is defined to be the cause of COVID-19, recently. It's known that COVID-19 goes with excessive immune reaction of human body in severe cases. Quercetin is reported to be effective on treatment and prophylaxis of other SARS like coronavirus infections, as a strong antioxidant and scavenger flavonoid without any adverse events. Upon this data, the investigators hypothesize that quercetin can be effective on both prophylaxis and treatment of COVID-19 cases. Therefore, the aim of this study to evaluate the possible role of quercetin on prophylaxis and treatment of COVID-19.
- Conditions
- COVID-19
- Being tested
- Quercetin Prophylaxis, Quercetin Treatment
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quercetin ProphylaxisDietary supplement
a daily dose of quercetin (500mg) will be taken by non-COVID-19 intervention group 1
Quercetin TreatmentDietary supplement
a daily dose of quercetin (1000mg) will be taken by proven COVID-19 cases intervention group 2
| Study group | Role | What they receive |
|---|---|---|
| non-quercetin group | No intervention | Participants, who accept to enroll the study without having quercetin prophylaxis and who do not have a history of COVID-19, will be in this group. |
| quercetin prophylaxis group | Active comparator | Participants, who takes a daily dose of 500mg quercetin and who not have a history of COVID-19, will be in this group. Receives: Dietary Supplement: Quercetin Prophylaxis |
| quercetin treatment group | Active comparator | Participants, who takes a daily dose of 1000mg quercetin and who are proven cases for COVID-19, will be in this group. Receives: Dietary Supplement: Quercetin Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of COVID-19 calculated using a questionnaire
Prevalence of COVID-19 in prophylaxis and sham group will be calculated using a questionnaire including hospital records
Measured: 3 months
Standardized Mortality rate
Mortality rate will be compared between two groups
Measured: 3 months
Secondary outcomes (1)
Morbidity rate
Morbidity rates besides recovery rates from COVID-19 will be documented
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2020
- Study start20 Mar 2020
- Primary completion31 Jul 2020
- Study completion31 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies 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
- None (open label)
- Enrolment
- 447 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Orbiteratec (funding)
- Responsible party
- Principal investigator, Hasan Onal, Kanuni Sultan Suleyman Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04377789
- Sponsor's protocol ID
- KSSEAH--0058
- Status last verified
- Feb 2021
- First submitted
- 1 May 2020
- Last updated
- 18 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Possible Effect of Quercetin on Prophylaxis and Treatment of COVID-19
- ClinicalTrials.gov ID
- NCT04377789
- Acronym / sponsor ID
- KSSEAH--0058
- Conditions
- COVID-19
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 447 participants (actual)
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research HospitalUniversity, hospital or other
- Collaborators
- Orbiteratec (funding)
- Study start
- 20 Mar 2020 (actual)
- Primary completion
- 31 Jul 2020 (actual)
- Study completion
- 31 Aug 2020 (actual)
- First posted
- 6 May 2020 (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.
Novel Coronavirus is defined to be the cause of COVID-19, recently. It's known that COVID-19 goes with excessive immune reaction of human body in severe cases. The investigators hypothesize that quercetin, as a strong scavenger and anti-inflammatory agent, can be effective on both prophylaxis and treatment of COVID-19 cases. Therefore, the aim of this study to evaluate the possible role of quercetin on prophylaxis and treatment of COVID-19.
Detailed description
Novel Coronavirus is defined to be the cause of COVID-19, recently. It's known that COVID-19 goes with excessive immune reaction of human body in severe cases. Quercetin is reported to be effective on treatment and prophylaxis of other SARS like coronavirus infections, as a strong antioxidant and scavenger flavonoid without any adverse events. Upon this data, the investigators hypothesize that quercetin can be effective on both prophylaxis and treatment of COVID-19 cases. Therefore, the aim of this study to evaluate the possible role of quercetin on prophylaxis and treatment of COVID-19.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| non-quercetin group | No intervention | –Participants, who accept to enroll the study without having quercetin prophylaxis and who do not have a history of COVID-19, will be in this group. |
| quercetin prophylaxis group | Active comparator | Dietary Supplement: Quercetin ProphylaxisParticipants, who takes a daily dose of 500mg quercetin and who not have a history of COVID-19, will be in this group. |
| quercetin treatment group | Active comparator | Dietary Supplement: Quercetin TreatmentParticipants, who takes a daily dose of 1000mg quercetin and who are proven cases for COVID-19, will be in this group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- moderate-high risk for COVID-19
- obtained informed consent
Key exclusion criteria (4 listed)
- declined to participate
- genetic/chromosomal abnormalities
- any kind of sensitivity or allergy for quercetin
- history of previous hypersensitivity with quercetin
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 |
|---|---|---|
| Quercetin Prophylaxisa daily dose of quercetin (500mg) will be taken by non-COVID-19 intervention group 1 | Dietary supplement | quercetin prophylaxis group |
| Quercetin Treatmenta daily dose of quercetin (1000mg) will be taken by proven COVID-19 cases intervention group 2 | Dietary supplement | quercetin treatment group |
Primary outcome
Prevalence of COVID-19 calculated using a questionnaire
Time frame: 3 months
Prevalence of COVID-19 in prophylaxis and sham group will be calculated using a questionnaire including hospital records
Standardized Mortality rate
Time frame: 3 months
Mortality rate will be compared between two groups
1 secondary outcome
Morbidity rate
Time frame: 3 months
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 18 Feb 2021.
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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.
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 Prophylaxis and Quercetin Treatment in people with COVID-19, run by Kanuni Sultan Suleyman Training 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 4 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 18 Feb 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?
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?
Prevalence of COVID-19 calculated using a questionnaire (time frame: 3 months). The study lists 2 primary outcomes in all. 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 18 Feb 2021.