a Randomized Double-blind StudyPhase 1QuercetixNCT04851821
The Effectiveness of Phytotherapy in SARS-COV2(COVID-19)
A Phase 1 study testing Quercetin in people with a Randomized Double-blind Study and Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), run by Hôpital Universitaire Sahloul at 1 site in Tunisia.
Trial summary
Quercetin is one of the flavonoids. Quercetin as well as rutin are recognized to be among the most active of the flavonoids. It is to quercetin that several medicinal plants, including ginkgo and St. John's Wort, owe part of their therapeutic effects. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- a Randomized Double-blind Study, Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), PHYTOTHERAPIE
- What is being tested?
- Quercetin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteTunisia
- Study dates
- 4 Jan 2021to 30 Jun 2021
- Phase
- Phase 1
- 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
- all patients attending the emergency department for influenza-like illness.
- Being over 18 years old
Who cannot join
- Any patient requiring admission
- Non-consenting patients
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effectiveness of Phytotherapy in the Treatment of SARS-COV2 (COVID-19)
Quercetin is one of the flavonoids. Quercetin as well as rutin are recognized to be among the most active of the flavonoids. It is to quercetin that several medicinal plants, including ginkgo and St. John's Wort, owe part of their therapeutic effects. Often combined with vitamin C in supplements, it improves absorption by the body and delays its elimination.
Quercetin is extracted from a variety of plant sources, including the onion peel and seeds and pods of Dimorphandra mollis, a tree in the legume family native to South America.
At present, there is no scientific data to demonstrate the effectiveness of herbal medicine, regardless of the plant, to prevent or treat COVID-19. On the other hand, some plant-based food supplements have anti-inflammatory or immunomodulatory properties that may disrupt inflammatory defense mechanisms useful in fighting infections, and in particular against COVID-19.
Read the detailed description
Type of study: a randomized, double-blind study using the Quercetine in the treatment of patients with SARS COV2 (covid-19) Quercetin is extracted from a variety of plant sources, including the onion peel and the seeds and pods of Dimorphandra mollis, a legume tree native to South America.
Although we are far from knowing everything about quercetin, its antioxidant, anti-inflammatory, and antihistamine (antiallergic) properties have been observed in numerous in vitro and animal studies.
History on quercetin In 1937, Albert Szent-Gyorgyi received a Nobel Prize for discovering vitamin C and flavonoids, as well as for exploring their biochemical properties. Originally, he gave the flavonoids the name "vitamin P" because of their effectiveness in reducing the permeability of blood vessels. This name was abandoned when it was realized that these substances were not really vitamins.
- Conditions
- a Randomized Double-blind Study, Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), PHYTOTHERAPIE
- Being tested
- Quercetin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuercetinDrug
Also called PLACEBO
Each patient included, after signing the consent, will have a treatment for ten days: one tablet times three per day 30 minutes before the meal.
| Study group | Role | What they receive |
|---|---|---|
| Quercetix group | Experimental | Each patient included, after signing the consent, will have a treatment for ten days: one tablet twice a day 30 minutes before the meal. Receives: Drug: Quercetin |
| Placebo Group | Placebo comparator | Each patient included, after signing the consent, will have a treatment for ten days: one tablet twice a day 30 minutes before the meal. Receives: Drug: Quercetin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients
Number of patients attending the emergency room
Measured: 10 DAYS
Secondary outcomes (2)
disappearance of symptoms
Date of disappearance of symptoms present on admission
Measured: 10 days
adverse reaction
Presence of an adverse reaction due to the administration of the treatment
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2021
- Study start4 Jan 2021
- Primary completion30 May 2021
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for a Randomized Double-blind StudyStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hôpital Universitaire Sahloul
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Riadh Boukef, Hôpital Universitaire Sahloul
- Investigators
- Riadh Boukef, professor, Principal investigator, CHU Sahloul, Sousse, Tunisia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04851821
- Sponsor's protocol ID
- Quercetix
- Acronym
- Quercetix
- Status last verified
- Jan 2023
- First submitted
- 6 Feb 2021
- Last updated
- 4 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Statistical analysis Plan can be shared in supplimentary data
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Phytotherapy in the Treatment of SARS-COV2 (COVID-19)
- ClinicalTrials.gov ID
- NCT04851821
- Acronym / sponsor ID
- Quercetix / Quercetix
- Conditions
- a Randomized Double-blind Study, Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), PHYTOTHERAPIE
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Hôpital Universitaire SahloulUniversity, hospital or other
- Study start
- 4 Jan 2021 (actual)
- Primary completion
- 30 May 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 20 Apr 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 one of the flavonoids. Quercetin as well as rutin are recognized to be among the most active of the flavonoids. It is to quercetin that several medicinal plants, including ginkgo and St. John's Wort, owe part of their therapeutic effects. Often combined with vitamin C in supplements, it improves absorption by the body and delays its elimination.
Quercetin is extracted from a variety of plant sources, including the onion peel and seeds and pods of Dimorphandra mollis, a tree in the legume family native to South America.
At present, there is no scientific data to demonstrate the effectiveness of herbal medicine, regardless of the plant, to prevent or treat COVID-19. On the other hand, some plant-based food supplements have anti-inflammatory or immunomodulatory properties that may disrupt inflammatory defense mechanisms useful in fighting infections, and in particular against COVID-19.
Detailed description
Type of study: a randomized, double-blind study using the Quercetine in the treatment of patients with SARS COV2 (covid-19) Quercetin is extracted from a variety of plant sources, including the onion peel and the seeds and pods of Dimorphandra mollis, a legume tree native to South America.
Although we are far from knowing everything about quercetin, its antioxidant, anti-inflammatory, and antihistamine (antiallergic) properties have been observed in numerous in vitro and animal studies.
History on quercetin In 1937, Albert Szent-Gyorgyi received a Nobel Prize for discovering vitamin C and flavonoids, as well as for exploring their biochemical properties. Originally, he gave the flavonoids the name "vitamin P" because of their effectiveness in reducing the permeability of blood vessels. This name was abandoned when it was realized that these substances were not really vitamins.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Quercetix group | Experimental | Drug: QuercetinEach patient included, after signing the consent, will have a treatment for ten days: one tablet twice a day 30 minutes before the meal. |
| Placebo Group | Placebo comparator | Drug: QuercetinEach patient included, after signing the consent, will have a treatment for ten days: one tablet twice a day 30 minutes before the meal. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- all patients attending the emergency department for influenza-like illness.
- Being over 18 years old
Key exclusion criteria (2 listed)
- Any patient requiring admission
- Non-consenting patients
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 |
|---|---|---|
| QuercetinAlso: PLACEBOEach patient included, after signing the consent, will have a treatment for ten days: one tablet times three per day 30 minutes before the meal. | Drug | Placebo Group, Quercetix group |
Primary outcome
Number of patients
Time frame: 10 DAYS
Number of patients attending the emergency room
2 secondary outcomes
disappearance of symptoms
Time frame: 10 days
adverse reaction
Time frame: 10 days
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 4 Jan 2023.
- Individual participant dataSharing planned: Yes. Statistical analysis Plan can be shared in supplimentary data
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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.
Riadh Boukef, professor principal investigator
CHU Sahloul, Sousse, Tunisia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Quercetin in people with a Randomized Double-blind Study and Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), run by Hôpital Universitaire Sahloul at 1 site in Tunisia.
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 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 4 Jan 2023. 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 Tunisia. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Number of patients (time frame: 10 DAYS). 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 4 Jan 2023.