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Completed

NCT Number: NCT04861298

Study to Investigate the Clinical Benefits of Dietary Supplement Quercetin for Managing Early Mild Symptoms of COVID-19

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

King Edward Medical University Teaching Hospital

Lahore, Punjab Province, 54000, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

standard of care for COVID-19 as per the hospital guidelines

Drug

Hospital standard of care treatment for COVID-19

Quercetin Phytosome (QP)

Dietary Supplement

Daily dose of 600 mg of Quercetin for 1st week and then 400 mg for the 2nd week

Primary outcomes

  1. Testing negative for SARS-CoV-2 by RT-PCR with symptoms improvement

    Time frame: From day 1 to day 14

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

King Edward Medical University

Other

Registry information

Official study title

Study to Investigate the Benefits of Dietary Supplement Quercetin for Early Symptoms of COVID-19

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Apr 27, 2021
Registry last updated
Feb 7, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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