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Completed

NCT Number: NCT04853199

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

HU Sahloul, sousse, Tunisia, Sousse, Itinéraire Ceinture Cité Sahloul, Tunisia

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • • 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;
  • 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.

Exclusion criteria

  • • 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.

Treatment and study plan

Quercetin

Drug

Each patient should receive one tablet twice a day 30 minutes before the meal

Placebo

Drug

Each placebo capsule contains 150 mg of microcrystalline cellulose and 1.5 mg of magnesium stearate.

Primary outcomes

  1. Mortality rate

    Time frame: 30 days

    death rate

  2. Need for ICU admission

    Time frame: 30 days

    Number of participants admitted to the Intensive care unit (ICU)

  3. treatment safety

    Time frame: 30 days

    rate of adverse events

Secondary outcomes

  1. Need for hospitalization for patients followed up at home

    Time frame: 30 days

    Need for hospitalization for patients followed up initially at home

  2. lenghth of stay in Hospital

    Time frame: 30 days

    days spent at hospital for patients followed up initially at home

  3. resolution of COVID-19 symptoms

    Time frame: 30 days

    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

  4. need for oxygen therapy

    Time frame: 30 days

    Number of participants who needed oxygen therapy

Sponsors and collaborators

Lead sponsor

Hôpital Universitaire Sahloul

Other

Registry information

Official study title

Effectiveness of Quercetin In The Treatment of SARS-COV 2

Acronym: QUERCOV

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Apr 21, 2021
Registry last updated
Jul 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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