Effect of Quercetin on Prophylaxis and Treatment of COVID-19

Sponsor

Kanuni Sultan Suleyman Training and Research Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT04377789

Collaborator

Orbiteratec (funding) (Other)

447

Enrollment

Location

Arms

5.4

Actual Duration (Months)

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
COVID-19	Dietary Supplement: Quercetin Prophylaxis Dietary Supplement: Quercetin Treatment	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

447 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

The Possible Effect of Quercetin on Prophylaxis and Treatment of COVID-19

Actual Study Start Date :

Mar 20, 2020

Actual Primary Completion Date :

Jul 31, 2020

Actual Study Completion Date :

Aug 31, 2020

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: non-quercetin group 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.
Active Comparator: quercetin prophylaxis group 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 a daily dose of quercetin (500mg) will be taken by non-COVID-19 intervention group 1
Active Comparator: quercetin treatment group 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 a daily dose of quercetin (1000mg) will be taken by proven COVID-19 cases intervention group 2

Arm

Intervention/Treatment

No Intervention: non-quercetin group

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.

Active Comparator: quercetin prophylaxis group

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

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

Active Comparator: quercetin treatment group

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

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

Outcome Measures

Primary Outcome Measures

Prevalence of COVID-19 calculated using a questionnaire [3 months]
Prevalence of COVID-19 in prophylaxis and sham group will be calculated using a questionnaire including hospital records
Standardized Mortality rate [3 months]
Mortality rate will be compared between two groups

Secondary Outcome Measures

Morbidity rate [3 months]
Morbidity rates besides recovery rates from COVID-19 will be documented

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kanuni Sultan Suleyman Training and Research Hospital	Istanbul		Turkey	34303

Sponsors and Collaborators

Kanuni Sultan Suleyman Training and Research Hospital
Orbiteratec (funding)

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hasan Onal, Professor, Kanuni Sultan Suleyman Training and Research Hospital

ClinicalTrials.gov Identifier:

NCT04377789

Other Study ID Numbers:

KSSEAH--0058

First Posted:

May 6, 2020

Last Update Posted:

Feb 18, 2021

Last Verified:

Feb 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

COVID-19

Quercetin

Study Results

No Results Posted as of Feb 18, 2021