Quercetin In The Treatment Of SARS-COV 2 (QUERCOV)

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.

Study Overview

• Status: Completed
• Conditions: SARS (Severe Acute Respiratory Syndrome)
• Intervention / Treatment: Drug: Quercetin; Drug: Placebo

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 Type: Interventional
• Enrollment (Actual): 200
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Boukef Riadh, professor; Phone Number: 00216 98676745; Email: riadboukef@gmail.com
• Study Contact Backup: Name: Imen Trabelsi, PhD; Phone Number: 00216 22739092; Email: imentrabelsi@hotmail.fr

Study Locations

• Tunisia
  • Itinéraire Ceinture Cité Sahloul
    • Sousse, Itinéraire Ceinture Cité Sahloul, Tunisia, 4054
      • HU Sahloul, sousse, Tunisia
  • Sousse
    • Sahloul, Sousse, Tunisia
      • Riadh Boukef

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Quercetin group; 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 should receive one tablet twice a day 30 minutes before the meal
Placebo Comparator: Placebo Group; 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 placebo capsule contains 150 mg of microcrystalline cellulose and 1.5 mg of magnesium stearate.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
treatment safety	rate of adverse events	30 days
Mortality rate	death rate	30 days
Need for ICU admission	Number of participants admitted to the Intensive care unit (ICU)	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Need for hospitalization for patients followed up at home	Need for hospitalization for patients followed up initially at home	30 days
lenghth of stay in Hospital	days spent at hospital for patients followed up initially at home	30 days
need for oxygen therapy	Number of participants who needed oxygen therapy	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	30 days

Collaborators and Investigators

• Sponsor: Hôpital Universitaire Sahloul
• Investigators: Principal Investigator: Riadh Boukef, professor, CHU Sahloul, Sousse, Tunisia

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2021
• Primary Completion (Actual): July 30, 2021
• Study Completion (Actual): August 30, 2021

Study Registration Dates

• First Submitted: April 18, 2021
• First Submitted That Met QC Criteria: April 18, 2021
• First Posted (Actual): April 21, 2021

Study Record Updates

• Last Update Posted (Actual): July 6, 2023
• Last Update Submitted That Met QC Criteria: July 4, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Severe Acute Respiratory Syndrome; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Protective Agents; Antioxidants; Quercetin
• Other Study ID Numbers: QUERCOV

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

IPD Plan Description

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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No