NCT04377789

Brief Summary

Novel Coronavirus is defined to be the cause of COVID-19, recently. It's known that COVID-19 goes with excessive immune reaction of human body in severe cases. The investigators hypothesize that quercetin, as a strong scavenger and anti-inflammatory agent, can be effective on both prophylaxis and treatment of COVID-19 cases. Therefore, the aim of this study to evaluate the possible role of quercetin on prophylaxis and treatment of COVID-19.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
447

participants targeted

Target at P75+ for not_applicable covid19

Timeline
Completed

Started Mar 2020

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

March 20, 2020

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 1, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 6, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2020

Completed
Last Updated

February 18, 2021

Status Verified

February 1, 2021

Enrollment Period

4 months

First QC Date

May 1, 2020

Last Update Submit

February 17, 2021

Conditions

Outcome Measures

Primary Outcomes (2)

  • Prevalence of COVID-19 calculated using a questionnaire

    Prevalence of COVID-19 in prophylaxis and sham group will be calculated using a questionnaire including hospital records

    3 months

  • Standardized Mortality rate

    Mortality rate will be compared between two groups

    3 months

Secondary Outcomes (1)

  • Morbidity rate

    3 months

Study Arms (3)

non-quercetin group

NO INTERVENTION

Participants, who accept to enroll the study without having quercetin prophylaxis and who do not have a history of COVID-19, will be in this group.

quercetin prophylaxis group

ACTIVE COMPARATOR

Participants, who takes a daily dose of 500mg quercetin and who not have a history of COVID-19, will be in this group.

Dietary Supplement: Quercetin Prophylaxis

quercetin treatment group

ACTIVE COMPARATOR

Participants, who takes a daily dose of 1000mg quercetin and who are proven cases for COVID-19, will be in this group.

Dietary Supplement: Quercetin Treatment

Interventions

Quercetin ProphylaxisDIETARY_SUPPLEMENT

a daily dose of quercetin (500mg) will be taken by non-COVID-19 intervention group 1

quercetin prophylaxis group
Quercetin TreatmentDIETARY_SUPPLEMENT

a daily dose of quercetin (1000mg) will be taken by proven COVID-19 cases intervention group 2

quercetin treatment group

Eligibility Criteria

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

You may qualify if:

  • moderate-high risk for COVID-19
  • obtained informed consent

You may not qualify if:

  • declined to participate
  • genetic/chromosomal abnormalities
  • any kind of sensitivity or allergy for quercetin
  • history of previous hypersensitivity with quercetin

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kanuni Sultan Suleyman Training and Research Hospital

Istanbul, 34303, Turkey (Türkiye)

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 1, 2020

First Posted

May 6, 2020

Study Start

March 20, 2020

Primary Completion

July 31, 2020

Study Completion

August 31, 2020

Last Updated

February 18, 2021

Record last verified: 2021-02

Locations