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Effect of Quercetin on Prophylaxis and Treatment of COVID-19

Primary Purpose

COVID-19

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Quercetin Prophylaxis
Quercetin Treatment
Sponsored by
Kanuni Sultan Suleyman Training and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for COVID-19

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • Kanuni Sultan Suleyman Training and Research Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Active Comparator

Active Comparator

Arm Label

non-quercetin group

quercetin prophylaxis group

quercetin treatment group

Arm Description

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.

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

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

Outcomes

Primary Outcome Measures

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
Standardized Mortality rate
Mortality rate will be compared between two groups

Secondary Outcome Measures

Morbidity rate
Morbidity rates besides recovery rates from COVID-19 will be documented

Full Information

First Posted
May 1, 2020
Last Updated
February 17, 2021
Sponsor
Kanuni Sultan Suleyman Training and Research Hospital
Collaborators
Orbiteratec (funding)
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1. Study Identification

Unique Protocol Identification Number
NCT04377789
Brief Title
Effect of Quercetin on Prophylaxis and Treatment of COVID-19
Official Title
The Possible Effect of Quercetin on Prophylaxis and Treatment of COVID-19
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
March 20, 2020 (Actual)
Primary Completion Date
July 31, 2020 (Actual)
Study Completion Date
August 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kanuni Sultan Suleyman Training and Research Hospital
Collaborators
Orbiteratec (funding)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
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. Quercetin is reported to be effective on treatment and prophylaxis of other SARS like coronavirus infections, as a strong antioxidant and scavenger flavonoid without any adverse events. Upon this data, the investigators hypothesize that quercetin 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
447 (Actual)

8. Arms, Groups, and Interventions

Arm Title
non-quercetin group
Arm Type
No Intervention
Arm Description
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.
Arm Title
quercetin prophylaxis group
Arm Type
Active Comparator
Arm Description
Participants, who takes a daily dose of 500mg quercetin and who not have a history of COVID-19, will be in this group.
Arm Title
quercetin treatment group
Arm Type
Active Comparator
Arm Description
Participants, who takes a daily dose of 1000mg quercetin and who are proven cases for COVID-19, will be in this group.
Intervention Type
Dietary Supplement
Intervention Name(s)
Quercetin Prophylaxis
Intervention Description
a daily dose of quercetin (500mg) will be taken by non-COVID-19 intervention group 1
Intervention Type
Dietary Supplement
Intervention Name(s)
Quercetin Treatment
Intervention Description
a daily dose of quercetin (1000mg) will be taken by proven COVID-19 cases intervention group 2
Primary Outcome Measure Information:
Title
Prevalence of COVID-19 calculated using a questionnaire
Description
Prevalence of COVID-19 in prophylaxis and sham group will be calculated using a questionnaire including hospital records
Time Frame
3 months
Title
Standardized Mortality rate
Description
Mortality rate will be compared between two groups
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Morbidity rate
Description
Morbidity rates besides recovery rates from COVID-19 will be documented
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: moderate-high risk for COVID-19 obtained informed consent Exclusion Criteria: declined to participate genetic/chromosomal abnormalities any kind of sensitivity or allergy for quercetin history of previous hypersensitivity with quercetin
Facility Information:
Facility Name
Kanuni Sultan Suleyman Training and Research Hospital
City
Istanbul
ZIP/Postal Code
34303
Country
Turkey

12. IPD Sharing Statement

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Effect of Quercetin on Prophylaxis and Treatment of COVID-19

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