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Effect of Quercetin on Prophylaxis and Treatment of COVID-19

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04377789
Recruitment Status : Completed
First Posted : May 6, 2020
Last Update Posted : February 18, 2021
Sponsor:
Collaborator:
Orbiteratec (funding)
Information provided by (Responsible Party):
Hasan Onal, Kanuni Sultan Suleyman Training and Research Hospital

Study Description
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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 Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
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 : March 20, 2020
Actual Primary Completion Date : July 31, 2020
Actual Study Completion Date : August 31, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Quercetin

Arms and Interventions
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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
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Primary Outcome Measures :
  1. Prevalence of COVID-19 calculated using a questionnaire [ Time Frame: 3 months ]
    Prevalence of COVID-19 in prophylaxis and sham group will be calculated using a questionnaire including hospital records

  2. Standardized Mortality rate [ Time Frame: 3 months ]
    Mortality rate will be compared between two groups


Secondary Outcome Measures :
  1. Morbidity rate [ Time Frame: 3 months ]
    Morbidity rates besides recovery rates from COVID-19 will be documented


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04377789


Locations
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Turkey
Kanuni Sultan Suleyman Training and Research Hospital
Istanbul, Turkey, 34303
Sponsors and Collaborators
Kanuni Sultan Suleyman Training and Research Hospital
Orbiteratec (funding)
More Information
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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    Key Record Dates
Last Update Posted: February 18, 2021
Last Verified: February 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Quercetin
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs