NCT05037240

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P25-P50 for not_applicable covid19

Timeline
Completed

Started Jan 2021

Shorter than P25 for not_applicable covid19

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 12, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 6, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 25, 2021

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 3, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 8, 2021

Completed
Last Updated

September 8, 2021

Status Verified

September 1, 2021

Enrollment Period

3 months

First QC Date

September 3, 2021

Last Update Submit

September 6, 2021

Conditions

Covid19

Outcome Measures

Primary Outcomes (1)

  • Prevention of Covid-19 infection

    A nasopharyngeal antigenic swab

    Absence of Covid-19 infection at 3 months

Study Arms (2)

Intervention Group

ACTIVE COMPARATOR
Dietary Supplement: Quercetin

Placebo

PLACEBO COMPARATOR
Combination Product: Placebo

Interventions

QuercetinDIETARY_SUPPLEMENT

Quercetin (500 mg), 2 times a day for 3 months

Intervention Group
PlaceboCOMBINATION_PRODUCT

500 mg, 2 times a day for 3 months

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Absence of Covid-19 infection

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mariangela Rondanelli

Pavia, 27100, Italy

Location

MeSH Terms

Conditions

COVID-19

Interventions

Quercetin

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

FlavonolsFlavonoidsChromonesBenzopyransPyransHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 3, 2021

First Posted

September 8, 2021

Study Start

January 12, 2021

Primary Completion

April 6, 2021

Study Completion

May 25, 2021

Last Updated

September 8, 2021

Record last verified: 2021-09

Locations

IT(1)