Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04853199
Recruitment Status : Recruiting
First Posted : April 21, 2021
Last Update Posted : July 28, 2021
Sponsor:
Information provided by (Responsible Party):
Hôpital Universitaire Sahloul

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief 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. 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.


Condition or disease Intervention/treatment Phase
SARS (Severe Acute Respiratory Syndrome) Drug: Quercetin Drug: Placebo Early Phase 1

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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: a randomized double-blind study
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Effectiveness of Quercetin In The Treatment of SARS-COV 2
Actual Study Start Date : June 1, 2021
Estimated Primary Completion Date : July 30, 2021
Estimated Study Completion Date : August 30, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Quercetin

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. The Efficacy measurment [ Time Frame: 10 and 30 days ]
    To study the effectiveness of a herbal medicine supplement in the treatment of COVID 19


Secondary Outcome Measures :
  1. DEATH [ Time Frame: one month ]
    The composite of death or need due to COVID-19 infection

  2. HOSPITALISATION [ Time Frame: one month ]
    The need for hospitalization due to COVID-19 infection


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04853199


Contacts
Layout table for location contacts
Contact: Boukef Riadh, professor 98676745 ext 00216 riadboukef@gmail.com
Contact: Imen Trabelsi, PhD 22739092 ext 00216 imentrabelsi@hotmail.fr

Locations
Layout table for location information
Tunisia
HU Sahloul, sousse, Tunisia Recruiting
Sousse, Itinéraire Ceinture Cité Sahloul, Tunisia, 4054
Contact: boukef riadh, professor    73 369 411    riadboukef@gmail.com   
Riadh Boukef Recruiting
Sahloul, Sousse, Tunisia
Contact: RIADH BOUKEF, Professor    0021698676745    riadboukef@gmail.com   
Sponsors and Collaborators
Hôpital Universitaire Sahloul
Investigators
Layout table for investigator information
Principal Investigator: Riadh Boukef, professor CHU Sahloul, Sousse, Tunisia
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Hôpital Universitaire Sahloul
ClinicalTrials.gov Identifier: NCT04853199    
Other Study ID Numbers: QUERCOV
First Posted: April 21, 2021    Key Record Dates
Last Update Posted: July 28, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
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

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Severe Acute Respiratory Syndrome
Respiratory Tract Infections
Infections
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
 Virus Diseases
Respiratory Tract Diseases
Quercetin
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs