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

Primary Purpose

SARS (Severe Acute Respiratory Syndrome)

Status

Completed

Phase

Early Phase 1

Locations

Tunisia

Study Type

Interventional

Intervention

Quercetin

Placebo

About this trial

This is an interventional treatment trial for SARS (Severe Acute Respiratory Syndrome)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

HU Sahloul, sousse, Tunisia
Riadh Boukef

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Quercetin group

Placebo Group

Arm Description

Each patient included, after signing the consent, will have a treatment for ten days: one tablet twice a day 30 minutes before the meal

Outcomes

Primary Outcome Measures

Mortality rate

death rate

Need for ICU admission

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

treatment safety

rate of adverse events

Secondary Outcome Measures

Need for hospitalization for patients followed up at home

Need for hospitalization for patients followed up initially at home

lenghth of stay in Hospital

days spent at hospital for patients followed up initially at home

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

need for oxygen therapy

Number of participants who needed oxygen therapy

Full Information

NCT ID

NCT04853199

First Posted

April 18, 2021

Last Updated

July 4, 2023

Sponsor

Hôpital Universitaire Sahloul

1. Study Identification

Unique Protocol Identification Number

NCT04853199

Brief Title

Quercetin In The Treatment Of SARS-COV 2

Acronym

QUERCOV

Official Title

Effectiveness of Quercetin In The Treatment of SARS-COV 2

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Completed

Study Start Date

June 1, 2021 (Actual)

Primary Completion Date

July 30, 2021 (Actual)

Study Completion Date

August 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Hôpital Universitaire Sahloul

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

SARS (Severe Acute Respiratory Syndrome)

7. Study Design

Primary Purpose

Treatment

Study Phase

Early Phase 1

Interventional Study Model

Parallel Assignment

Model Description

a randomized double-blind study

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

200 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Quercetin group

Arm Type

Experimental

Arm Description

Each patient included, after signing the consent, will have a treatment for ten days: one tablet twice a day 30 minutes before the meal

Arm Title

Placebo Group

Arm Type

Placebo Comparator

Arm Description

Each patient included, after signing the consent, will have a treatment for ten days: one tablet twice a day 30 minutes before the meal

Intervention Type

Drug

Intervention Name(s)

Quercetin

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

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

Primary Outcome Measure Information:

Title

Mortality rate

Description

death rate

Time Frame

30 days

Title

Need for ICU admission

Description

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

Time Frame

30 days

Title

treatment safety

Description

rate of adverse events

Time Frame

30 days

Secondary Outcome Measure Information:

Title

Need for hospitalization for patients followed up at home

Description

Need for hospitalization for patients followed up initially at home

Time Frame

30 days

Title

lenghth of stay in Hospital

Description

days spent at hospital for patients followed up initially at home

Time Frame

30 days

Title

resolution of COVID-19 symptoms

Description

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

Title

need for oxygen therapy

Description

Number of participants who needed oxygen therapy

Time Frame

30 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Riadh Boukef, professor

Organizational Affiliation

CHU Sahloul, Sousse, Tunisia

Official's Role

Principal Investigator

Facility Information:

Facility Name

HU Sahloul, sousse, Tunisia

City

Sousse

State/Province

Itinéraire Ceinture Cité Sahloul

ZIP/Postal Code

4054

Country

Tunisia

Facility Name

Riadh Boukef

City

Sahloul

State/Province

Sousse

Country

Tunisia

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing 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

Learn more about this trial

Quercetin In The Treatment Of SARS-COV 2

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