An Early Phase 1 interventional study of Quercetin and Placebo in SARS (Severe Acute Respiratory Syndrome), sponsored by Hôpital Universitaire Sahloul. Completed at 2 sites in Tunisia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-07-06.
Sponsored by Hôpital Universitaire Sahloul · Early Phase 1, Interventional, and Treatment
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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.
Properties
376 studies on the registry are indexed under Severe Acute Respiratory Syndrome; 15 are open to participants now.
This study's enrollment of 200 is above the median of 145 across 211 interventional studies indexed under Severe Acute Respiratory Syndrome.
Browse Severe Acute Respiratory Syndrome studies →Hôpital Universitaire Sahloul is the lead sponsor of 17 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Clinical score greater than 6
Exclusion Criteria:
Patient currently in shock or exhibiting hemodynamic instability;
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Each patient included, after signing the consent, will have a treatment for ten days: one tablet twice a day 30 minutes before the meal
Drug: Quercetin
Each patient included, after signing the consent, will have a treatment for ten days: one tablet twice a day 30 minutes before the meal
Drug: Placebo
Each patient should receive one tablet twice a day 30 minutes before the meal
Each placebo capsule contains 150 mg of microcrystalline cellulose and 1.5 mg of magnesium stearate.
Mortality rate
death rate
Time frame: 30 days
Need for ICU admission
Number of participants admitted to the Intensive care unit (ICU)
Time frame: 30 days
treatment safety
rate of adverse events
Time frame: 30 days
Need for hospitalization for patients followed up at home
Need for hospitalization for patients followed up initially at home
Time frame: 30 days
lenghth of stay in Hospital
days spent at hospital for patients followed up initially at home
Time frame: 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
Time frame: 30 days
need for oxygen therapy
Number of participants who needed oxygen therapy
Time frame: 30 days
Plan to share: 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
No publications or documents are linked to this record.
Ran from Jun 2021 to primary completion in Jul 2021, 1 month.
Of 18 phase 1 interventional studies under Severe Acute Respiratory Syndrome, half reached primary completion within 10 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 15. This study's 1 month is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Quercetin
Severe Acute Respiratory Syndrome →
Hôpital Universitaire Sahloul