Quercetin in the Prevention of Covid-19 Infection

September 6, 2021 updated by: Azienda di Servizi alla Persona di Pavia

Randomized, Placebo-controlled Clinical Trial to Evaluate the Efficacy of an Oral Nutritional Supplement Based on Quercetin in the Prevention of Covid-19 Infection for a Duration of 3 Months

Quercetin is a flavonol, a subclass of flavonoid compounds. Of the flavonol molecules, quercetin is the most abundant in fruit and vegetables. Quercetin flavonol is characterized by 3 crucial properties: antioxidant, anti-inflammatory and immunomodulatory. The combination of these 3 properties makes quercetin an excellent candidate for dealing with situations in which oxidative stress, inflammation and the immune system are involved. The purpose of the study is to evaluate the effectiveness of an oral nutritional supplement based on quercetin in the prevention of Covid-19 infection.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Pavia, Italy, 27100
        • Mariangela Rondanelli

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Absence of Covid-19 infection

Exclusion Criteria:

  • Previous Sars-Cov-2 infection demonstrated with antibody positivity through venous sampling
  • Demonstrated presence of Sars-Cov-2 through a nasopharyngeal antigenic swab before the start of oral nutritional supplementation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Placebo
Combination product: Placebo
500 mg, 2 times a day for 3 months
ACTIVE_COMPARATOR: Intervention Group
Dietary supplement: Quercetin
Quercetin (500 mg), 2 times a day for 3 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevention of Covid-19 infection
Time Frame: Absence of Covid-19 infection at 3 months
A nasopharyngeal antigenic swab
Absence of Covid-19 infection at 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Azienda di Servizi alla Persona di Pavia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 12, 2021

Primary Completion (ACTUAL)

April 6, 2021

Study Completion (ACTUAL)

May 25, 2021

Study Registration Dates

First Submitted

September 3, 2021

First Submitted That Met QC Criteria

September 6, 2021

First Posted (ACTUAL)

September 8, 2021

Study Record Updates

Last Update Posted (ACTUAL)

September 8, 2021

Last Update Submitted That Met QC Criteria

September 6, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1222/01022021

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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