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

COVID-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04861298
• Other study ID #: 192/RC/KEMU
• Status: Completed
• Phase: N/A
• Start date: January 11, 2021
• Est. completion date: August 29, 2021

Study information

• Verified date: January 2022
• Source: King Edward Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: August 29, 2021
• Est. primary completion date: August 29, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 × 10?/L);
• Pregnant patients
• Patients declining to participate

Related Conditions & MeSH terms

• COVID-19

Intervention

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

Locations

Country	Name	City	State
Pakistan	King Edward Medical University Teaching Hospital	Lahore	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
King Edward Medical University

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Testing negative for SARS-CoV-2 by RT-PCR with symptoms improvement		From day 1 to day 14
Secondary	Percentage of subjects that require hospitalisation		From day 1 to day 14
Secondary	Improvement in CRP		From day 1 to day 14
Secondary	Improvement in D-Dimers		From day 1 to day 14
Secondary	Improvement in LDH		From day 1 to day 14
Secondary	Improvement in Ferritin		From day 1 to day 14
Secondary	Improvement in CBC		From day 1 to day 14