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

Study to Investigate the Benefits of Dietary Supplement Quercetin for Early 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.

Study Overview

• Status: Completed
• Conditions: COVID-19
• Intervention / Treatment: Drug: standard of care for COVID-19 as per the hospital guidelines; Dietary supplement: Quercetin Phytosome (QP)

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 Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Punjab
    • Lahore, Punjab, Pakistan, 54000
      • King Edward Medical University Teaching Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Testing negative for SARS-CoV-2 by RT-PCR with symptoms improvement	From day 1 to day 14

Secondary Outcome Measures

Outcome Measure	Time Frame
Percentage of subjects that require hospitalisation	From day 1 to day 14
Improvement in CRP	From day 1 to day 14
Improvement in D-Dimers	From day 1 to day 14
Improvement in LDH	From day 1 to day 14
Improvement in Ferritin	From day 1 to day 14
Improvement in CBC	From day 1 to day 14

Collaborators and Investigators

• Sponsor: King Edward Medical University

Study record dates

Study Major Dates

• Study Start (Actual): January 11, 2021
• Primary Completion (Actual): August 29, 2021
• Study Completion (Actual): August 29, 2021

Study Registration Dates

• First Submitted: April 25, 2021
• First Submitted That Met QC Criteria: April 25, 2021
• First Posted (Actual): April 27, 2021

Study Record Updates

• Last Update Posted (Actual): February 7, 2022
• Last Update Submitted That Met QC Criteria: January 23, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Protective Agents; Antioxidants; Quercetin
• Other Study ID Numbers: 192/RC/KEMU

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No