Quercetin In The Treatment Of SARS-COV 2

NCT04853199 | Completed Early Phase 1

• 1 other identifier: QUERCOV
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 2

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.

Conditions

SARS (Severe Acute Respiratory Syndrome)

Outcome Measures

Primary Outcomes (3)

• Mortality rate

  death rate

  30 days

• Need for ICU admission

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

  30 days

• treatment safety

  rate of adverse events

  30 days

Secondary Outcomes (4)

• Need for hospitalization for patients followed up at home

  30 days

• lenghth of stay in Hospital

  30 days

• resolution of COVID-19 symptoms

  30 days

• need for oxygen therapy

  30 days

Study Arms (2)

Quercetin group

EXPERIMENTAL

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

Placebo Group

PLACEBO COMPARATOR

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

Interventions

Quercetin DRUG

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

Quercetin group

Placebo DRUG

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

Placebo Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hôpital Universitaire Sahloul: lead

Study Sites (2)

HU Sahloul, sousse, Tunisia

Sousse, Itinéraire Ceinture Cité Sahloul, 4054, Tunisia

Location

Riadh Boukef

Sahloul, Sousse Governorate, Tunisia

Location

MeSH Terms

Conditions

Severe Acute Respiratory Syndrome

Interventions

Quercetin

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Flavonols; Flavonoids; Chromones; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Riadh Boukef, professor

  CHU Sahloul, Sousse, Tunisia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: a randomized double-blind study

Study Record Dates

• First Submitted: April 18, 2021
• First Posted: April 21, 2021
• Study Start: June 1, 2021
• Primary Completion: July 30, 2021
• Study Completion: August 30, 2021
• Last Updated: July 6, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)