Back to resultsQuercetin in the Prevention of Covid-19 Infection
Primary Purpose
Covid19
Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Quercetin
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Covid19
Eligibility Criteria
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
Sites / Locations
- Mariangela Rondanelli
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Intervention Group
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Prevention of Covid-19 infection
A nasopharyngeal antigenic swab
Secondary Outcome Measures
Full Information
NCT ID
NCT05037240
First Posted
September 3, 2021
Last Updated
September 6, 2021
Sponsor
Azienda di Servizi alla Persona di Pavia
1. Study Identification
Unique Protocol Identification Number
NCT05037240
Brief Title
Quercetin in the Prevention of Covid-19 Infection
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
January 12, 2021 (Actual)
Primary Completion Date
April 6, 2021 (Actual)
Study Completion Date
May 25, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Azienda di Servizi alla Persona di Pavia
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention Group
Arm Type
Active Comparator
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
Quercetin
Intervention Description
Quercetin (500 mg), 2 times a day for 3 months
Intervention Type
Combination Product
Intervention Name(s)
Placebo
Intervention Description
500 mg, 2 times a day for 3 months
Primary Outcome Measure Information:
Title
Prevention of Covid-19 infection
Description
A nasopharyngeal antigenic swab
Time Frame
Absence of Covid-19 infection at 3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Mariangela Rondanelli
City
Pavia
ZIP/Postal Code
27100
Country
Italy
12. IPD Sharing Statement
Learn more about this trial
Quercetin in the Prevention of Covid-19 Infection
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