SARS (Severe Acute Respiratory Syndrome)Early Phase 1QUERCOVNCT04853199
Quercetin In The Treatment Of SARS-COV 2
A Early Phase 1 study testing Quercetin in people with SARS (Severe Acute Respiratory Syndrome), run by Hôpital Universitaire Sahloul at 2 sites in Tunisia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- SARS (Severe Acute Respiratory Syndrome)
- 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
- 200 participants
- Where
- 2 sitesTunisia
- Study dates
- 1 Jun 2021to 30 Aug 2021
- Phase
- Early 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
- • Clinical score greater than 6
- Patients with clinical symptoms less than 5 days old.
- Men and women at least 40 years old, able and willing to give informed consent;
- Any patient over the age of 18 with a CT scan in favor of COVID-19;
- Ambulatory or hospitalized environment;
- Patient with dyspnea or with a positive gait test;
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- The patient must have at least one of the following high risk criteria: 70 years or older, obesity (BMI ≥ 30 kg / m2), diabetes mellitus, uncontrolled hypertension (systolic blood pressure ≥ 150 mm Hg), respiratory disease known (including asthma or chronic obstructive pulmonary disease), known heart failure, known coronary artery disease, fever ≥ 38.4 ° C within the last 48 hours, dyspnea at the time of presentation, bicytopenia, pancytopenia or a combination of a number high neutrophils and low lymphocytes count;
- The patient is not of childbearing age, defined as postmenopausal for at least 1 year or surgically sterile, or is of childbearing age and uses at least one method of contraception and preferably two complementary forms of contraception comprising a method of barrier throughout the study and for 30 days after the end of the study;
- The patient must be able and willing to comply with the requirements of this study protocol.
Who cannot join
- • Patient currently in shock or exhibiting hemodynamic instability;
- Patient with inflammatory bowel disease (Crohn's disease or ulcerative colitis), chronic diarrhea or malabsorption;
- Pregnant or breastfeeding patient
- Patient with a history of allergic reaction or significant sensitivity to Nigella;
- The patient is considered by the investigator, for whatever reason, to be an unsuitable candidate for the study.
Trial locations and contacts
2 sites in 1 country.
Tunisia2 sites
Riadh Boukef
Sahloul, Sousse Governorate
HU Sahloul, sousse, Tunisia
Sousse, Itinéraire Ceinture Cité Sahloul, 4054
About this study
Official title: Effectiveness of Quercetin In The Treatment of SARS-COV 2
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.
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.
Read the detailed description
Properties
- Anti-oxidant, vascular protector
- Inhibition of platelet aggregation, vasorelaxant , arterial relaxant
- Anti-hypertensive , especially by certain derivatives (quercetin-3-glucuronic acid)
- Nephroprotective in rats, protects against the nephrotoxicity of gentamicin
- Anticancer , with immunostimulatory activity and inducer of apoptosis, with activity on the shock proteins HSP (heat shock proteins) hsp27 and hsp70
- Antitumor activity against prostate cancer and certain breast cancer cells
- Prevention of cardiac toxicity from doxorubicin, with resveratrol
- Protection against gastric inflammation associated with Helicobacter pylori infection by activity on MAPK, BCL-2, BAX.
- Increases the antitoxic activity of the liver
- Pancreatic lipase inhibitor, potential action in weight gain
- Anti-inflammatory
- Anti-allergic, inhibition of mast cell degranulation, with a preventive effect, reduction of inflammation linked to eosinophils (such as isoquercitrin regulates the Th1 / Th2 balance
- Antiviral (dose-dependent reduction of infectivity, decreases intracellular replication)
- Inhibition of rhinovirus replication
- Influenza prophylaxis by quercetin or its derivatives (quercetin-3-O-α-L-rhamnopyranoside), opposes the pro-oxidant effects induced by the influenza virus, antioxidant therapy could be used to prevent serious complications associated with influenza
- In vitro inhibition of the penetration of the Ebola virus by quercetin-3-O-glucoside
- Antiviral activity against Zika virus, hepatitis B virus, hepatitis C, Epstein-Barr virus EBV and antitumor against human gastric carcinoma
- Conditions
- SARS (Severe Acute Respiratory Syndrome)
- Being tested
- Quercetin, Placebo
- Medical subject headings
- Severe Acute Respiratory Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuercetinDrug
Each patient should receive one tablet twice a day 30 minutes before the meal
PlaceboDrug
Each placebo capsule contains 150 mg of microcrystalline cellulose and 1.5 mg of magnesium stearate.
| Study group | Role | What they receive |
|---|---|---|
| Quercetin 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: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality rate
death rate
Measured: 30 days
Need for ICU admission
Number of participants admitted to the Intensive care unit (ICU)
Measured: 30 days
treatment safety
rate of adverse events
Measured: 30 days
Secondary outcomes (4)
Need for hospitalization for patients followed up at home
Need for hospitalization for patients followed up initially at home
Measured: 30 days
lenghth of stay in Hospital
days spent at hospital for patients followed up initially at home
Measured: 30 days
resolution of COVID-19 symptoms
Time to resolution of COVID-19 symptoms [ Evaluated at day 15 and day 30 precising the Time at which the patient is completely symptom free and severity of symptoms
Measured: 30 days
need for oxygen therapy
Number of participants who needed oxygen therapy
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2021
- Study start1 Jun 2021
- Primary completion30 Jul 2021
- Study completion30 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SARS (Severe Acute Respiratory Syndrome)Studies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- a randomized double-blind study
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 200 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
- NCT04853199
- Sponsor's protocol ID
- QUERCOV
- Acronym
- QUERCOV
- Status last verified
- Jul 2023
- First submitted
- 18 Apr 2021
- Last updated
- 6 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Two study groups will be included: 100 patients in the herbal medicine group and 100 patients in the Placebo group. For each patient included in the study, a PCR test for the detection of SARS-COV2 was performed with the prescription of a prescription containing: antibiotic therapy, paracetamol, cough syrup, mineral and vitamin supplements. A follow-up will be carried out for each patient included in the study every two days to note the clinical signs present and to verify compliance and adverse events for each. Data is entered on SPSS 21.0
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Quercetin In The Treatment of SARS-COV 2
- ClinicalTrials.gov ID
- NCT04853199
- Acronym / sponsor ID
- QUERCOV / QUERCOV
- Conditions
- SARS (Severe Acute Respiratory Syndrome)
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Hôpital Universitaire SahloulUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 30 Jul 2021 (actual)
- Study completion
- 30 Aug 2021 (actual)
- First posted
- 21 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.
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.
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.
Detailed description
Properties
- Anti-oxidant, vascular protector
- Inhibition of platelet aggregation, vasorelaxant , arterial relaxant
- Anti-hypertensive , especially by certain derivatives (quercetin-3-glucuronic acid)
- Nephroprotective in rats, protects against the nephrotoxicity of gentamicin
- Anticancer , with immunostimulatory activity and inducer of apoptosis, with activity on the shock proteins HSP (heat shock proteins) hsp27 and hsp70
- Antitumor activity against prostate cancer and certain breast cancer cells
- Prevention of cardiac toxicity from doxorubicin, with resveratrol
- Protection against gastric inflammation associated with Helicobacter pylori infection by activity on MAPK, BCL-2, BAX.
- Increases the antitoxic activity of the liver
- Pancreatic lipase inhibitor, potential action in weight gain
- Anti-inflammatory
- Anti-allergic, inhibition of mast cell degranulation, with a preventive effect, reduction of inflammation linked to eosinophils (such as isoquercitrin regulates the Th1 / Th2 balance
- Antiviral (dose-dependent reduction of infectivity, decreases intracellular replication)
- Inhibition of rhinovirus replication
- Influenza prophylaxis by quercetin or its derivatives (quercetin-3-O-α-L-rhamnopyranoside), opposes the pro-oxidant effects induced by the influenza virus, antioxidant therapy could be used to prevent serious complications associated with influenza
- In vitro inhibition of the penetration of the Ebola virus by quercetin-3-O-glucoside
- Antiviral activity against Zika virus, hepatitis B virus, hepatitis C, Epstein-Barr virus EBV and antitumor against human gastric carcinoma
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- a randomized double-blind study
| Arm | Type | Receives |
|---|---|---|
| Quercetin 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: PlaceboEach 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 (9 listed)
- • Clinical score greater than 6
Key exclusion criteria (5 listed)
- • Patient currently in shock or exhibiting hemodynamic instability;
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 |
|---|---|---|
| QuercetinEach patient should receive one tablet twice a day 30 minutes before the meal | Drug | Quercetin group |
| PlaceboEach placebo capsule contains 150 mg of microcrystalline cellulose and 1.5 mg of magnesium stearate. | Drug | Placebo Group |
Primary outcome
Mortality rate
Time frame: 30 days
death rate
Need for ICU admission
Time frame: 30 days
Number of participants admitted to the Intensive care unit (ICU)
treatment safety
Time frame: 30 days
rate of adverse events
4 secondary outcomes
Need for hospitalization for patients followed up at home
Time frame: 30 days
lenghth of stay in Hospital
Time frame: 30 days
resolution of COVID-19 symptoms
Time frame: 30 days
need for oxygen therapy
Time frame: 30 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 6 Jul 2023.
- Individual participant dataSharing planned: No. Two study groups will be included: 100 patients in the herbal medicine group and 100 patients in the Placebo group. For each patient included in the study, a PCR test for the detection of SARS-COV2 was performed with the prescription of a prescription containing: antibiotic therapy, paracetamol, cough syrup, mineral and vitamin supplements. A follow-up will be carried out for each patient included in the study every two days to note the clinical signs present and to verify compliance and adverse events for each. Data is entered on SPSS 21.0
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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
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Quercetin in people with SARS (Severe Acute Respiratory Syndrome), run by Hôpital Universitaire Sahloul at 2 sites 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 9 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: finished, as of the sponsor's last update on 6 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
Mortality rate (time frame: 30 days). The study lists 3 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 6 Jul 2023.