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Study to Investigate the Clinical Benefits of Dietary Supplement Quercetin for Managing Early Mild Symptoms 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: NCT04861298
Recruitment Status : Completed
First Posted : April 27, 2021
Last Update Posted : February 7, 2022
Sponsor:
Information provided by (Responsible Party):
King Edward Medical University

Study Description
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Brief Summary:
Quercetin is a flavonoid dietary supplement that occurs in many edible fruits and vegetables. It has remarkable antioxidant, anti-inflammatory, immunoprotective and antiviral properties. It is widely used to boost the body immune system against infections and keeping healthy life-style. The purpose of the present study is to investigate the potential benefits of quercetin for preventing COVID-19 disease progression and symptoms improvement in the early stage of infection.

Condition or disease Intervention/treatment Phase
COVID-19 Drug: standard of care for COVID-19 as per the hospital guidelines Dietary Supplement: Quercetin Phytosome (QP) Not Applicable

Detailed Description:

The strong antioxidant and anti-inflammatory properties of quercetin are closely related to its effective fight against a variety of disease conditions related to inflammation, including: viral infections, allergies, asthma, hay fever, arthritis, respiratory diseases, "hardening of the arteries" (atherosclerosis), high cholesterol, heart disease and circulation problems, insulin resistance and diabetes, eye-related disorders, including cataracts, stomach ulcers, cognitive impairment, gout, cancer, chronic fatigue syndrome, inflammation of the prostate, bladder, and ovaries, chronic infections of the prostate, skin disorders, including dermatitis and hives. Quercetin can help stop damaging particles in the body known as free radicals, which damages the cells by natural oxidation processes. It can also reduce the expression of inflammatory genes in the cells.

Quercetin has been shown to be effective against broad range of viruses including human respiratory syncytial virus (hRSV), rhinovirus, echovirus, coxsackievirus, poliovirus, parainfluenza type 3, Herpes Simplex Virus-1, cytomegalovirus, SARS-CoV-1, dengue virus, and Hepatitis C virus.

The purpose of the present study is to investigate the potential benefits of quercetin for preventing COVID-19 disease progression and improving symptoms in the early stage of infection.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Study to Investigate the Benefits of Dietary Supplement Quercetin for Early Symptoms of COVID-19
Actual Study Start Date : January 11, 2021
Actual Primary Completion Date : August 29, 2021
Actual Study Completion Date : August 29, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Quercetin

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Standard of care (SOC)
This arm will receive the standard of care (SOC) for COVID-19 as per the hospital guidelines.
 Drug: standard of care for COVID-19 as per the hospital guidelines
Hospital standard of care treatment for COVID-19
Experimental: Quercetin
This arm will receive standard of care + oral Quercetin for two weeks
 Drug: standard of care for COVID-19 as per the hospital guidelines
Hospital standard of care treatment for COVID-19

Dietary Supplement: Quercetin Phytosome (QP)
Daily dose of 600 mg of Quercetin for 1st week and then 400 mg for the 2nd week


Outcome Measures
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Primary Outcome Measures :
  1. Testing negative for SARS-CoV-2 by RT-PCR with symptoms improvement [ Time Frame: From day 1 to day 14 ]

Secondary Outcome Measures :
  1. Percentage of subjects that require hospitalisation [ Time Frame: From day 1 to day 14 ]
  2. Improvement in CRP [ Time Frame: From day 1 to day 14 ]
  3. Improvement in D-Dimers [ Time Frame: From day 1 to day 14 ]
  4. Improvement in LDH [ Time Frame: From day 1 to day 14 ]
  5. Improvement in Ferritin [ Time Frame: From day 1 to day 14 ]
  6. Improvement in CBC [ Time Frame: From day 1 to day 14 ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients must be 18 years of age or older, of either gender
  • Patients must be tested positive for SARS-CoV-2 by RT-PCR
  • Patients must exhibit typical symptoms of COVID-19 disease at screening such as fever, fatigue, a dry and contagious cough, loss of appetite, body aches, shortness of breath, mucus or phlegm, sore throat, headache, chills, sometimes with shaking, loss of smell or taste, congestion or runny nose, nausea, or vomiting, diarrhea, muscular pain etc.
  • Patients must be in the early stage of COVID-19 disease who do not require hospitalisation at the time of screening
  • Patients must be under the care of a Physician for diagnosis of COVID-19
  • Patients who have signed informed consent

Exclusion Criteria:

  • Patients with proven hypersensitivity or allergic reaction to quercetin
  • Patients with known chronic kidney disease with estimated creatinine clearance < 50 mL/minute or need for dialysis
  • Patients who are severely hypotensive defined as needing hemodynamic pressors to maintain blood pressure
  • Patients with moderate or severe thrombocytopenia (platelet count <100 × 10⁹/L);
  • Pregnant patients
  • Patients declining to participate
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): NCT04861298


Locations
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Pakistan
King Edward Medical University Teaching Hospital
Lahore, Punjab, Pakistan, 54000
Sponsors and Collaborators
King Edward Medical University
More Information
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Responsible Party: King Edward Medical University
ClinicalTrials.gov Identifier: NCT04861298    
Other Study ID Numbers: 192/RC/KEMU
First Posted: April 27, 2021    Key Record Dates
Last Update Posted: February 7, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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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COVID-19
Pneumonia, Viral
Pneumonia
Respiratory Tract Infections
Infections
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
 RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Quercetin
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs