Nutritional Supplementation of Flavonoids Quercetin and Curcumin for Early Mild Symptoms of COVID-19

COVID-19 Clinical Trial

Official title:

Treatment Benefits of Flavonoids Quercetin and Curcumin Supplements for Mild Symptoms of COVID-19

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05130671
• Other study ID #: 785/RC/KEMU/25.10.2021
• Status: Completed
• Phase: N/A
• Start date: October 25, 2021
• Est. completion date: December 31, 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

The purpose of this study is to investigate the therapeutic benefits of flavonoids nutritional supplements quercetin and curcumin for early mild symptoms of COVID-19.

Description:

Flavonoids nutritional supplements quercetin and curcumin have demonstrated strong antioxidant, broad-spectrum anti-viral and anti-inflammatory properties including against the respiratory tract infections. They are widely used to boost the immunity against infections and keeping healthy life-style. Results from recent published studies have shown positive results for quercetin and curcumin in patients with COVID-19.

In the present study the investigators aim to study the combined beneficial effects of quercetin and curcumin in addition to standard of care for managing early mild symptoms of COVID-19 in community-based patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 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 withshaking, 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 hospitalization 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 or curcumin

• 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 taking anticoagulant/antiplatelet drugs such as Coumarine, Heparine, Aspirin, Clopidrogel, dalteparin, enoxaparin, ticlopidine and warparin.

• Patients with gallstone obstruction

• Hypothyroid suppering patients

• Patients with moderate or severe thrombocytopenia (platelet count <100 ×10?/L);

• Pregnant patients

Related Conditions & MeSH terms

• COVID-19

Intervention

Drug:
• Standard of care
Standard of care treatment as per the hospital guidelines

Dietary Supplement:
• Investigational treatment
Combination of quercetin and curcumin as add-on to the standard of care

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 Reverse Transcription Polymerase Chain Reaction (RT-PCR)	Testing of naso-pharyngeal swab for COVID-19	Day 7
Primary	COVID-19 symptoms improvement	Improvement of the typical symptoms associated with COVID-19 infection	Day 7
Secondary	Improvement in CRP level	Improvement in the CRP levels	Day 7
Secondary	Improvement in D-dimers level	Improvement in D-dimers level	Day 7
Secondary	Improvement in LDH levels	Improvement in LDH levels	Day 7
Secondary	Improvement in ferritin levels	Improvement in Ferritin levels	Day 7
Secondary	Improvement in full blood count (CBC)	Improvement in CBC levels	Day 7