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

Primary Purpose

COVID-19

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
standard of care for COVID-19 as per the hospital guidelines
Quercetin Phytosome (QP)
Sponsored by
King Edward Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COVID-19

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • King Edward Medical University Teaching Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard of care (SOC)

Quercetin

Arm Description

This arm will receive the standard of care (SOC) for COVID-19 as per the hospital guidelines.

This arm will receive standard of care + oral Quercetin for two weeks

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Percentage of subjects that require hospitalisation
Improvement in CRP
Improvement in D-Dimers
Improvement in LDH
Improvement in Ferritin
Improvement in CBC

Full Information

First Posted
April 25, 2021
Last Updated
January 23, 2022
Sponsor
King Edward Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT04861298
Brief Title
Study to Investigate the Clinical Benefits of Dietary Supplement Quercetin for Managing Early Mild Symptoms of COVID-19
Official Title
Study to Investigate the Benefits of Dietary Supplement Quercetin for Early Symptoms of COVID-19
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
January 11, 2021 (Actual)
Primary Completion Date
August 29, 2021 (Actual)
Study Completion Date
August 29, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
King Edward Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard of care (SOC)
Arm Type
Active Comparator
Arm Description
This arm will receive the standard of care (SOC) for COVID-19 as per the hospital guidelines.
Arm Title
Quercetin
Arm Type
Experimental
Arm Description
This arm will receive standard of care + oral Quercetin for two weeks
Intervention Type
Drug
Intervention Name(s)
standard of care for COVID-19 as per the hospital guidelines
Intervention Description
Hospital standard of care treatment for COVID-19
Intervention Type
Dietary Supplement
Intervention Name(s)
Quercetin Phytosome (QP)
Intervention Description
Daily dose of 600 mg of Quercetin for 1st week and then 400 mg for the 2nd week
Primary Outcome Measure Information:
Title
Testing negative for SARS-CoV-2 by RT-PCR with symptoms improvement
Time Frame
From day 1 to day 14
Secondary Outcome Measure Information:
Title
Percentage of subjects that require hospitalisation
Time Frame
From day 1 to day 14
Title
Improvement in CRP
Time Frame
From day 1 to day 14
Title
Improvement in D-Dimers
Time Frame
From day 1 to day 14
Title
Improvement in LDH
Time Frame
From day 1 to day 14
Title
Improvement in Ferritin
Time Frame
From day 1 to day 14
Title
Improvement in CBC
Time Frame
From day 1 to day 14

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
King Edward Medical University Teaching Hospital
City
Lahore
State/Province
Punjab
ZIP/Postal Code
54000
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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