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

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

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.

Study Overview

• Status: Completed
• Conditions: COVID-19
• Intervention / Treatment: Drug: Standard of care; Dietary supplement: Investigational treatment

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 50
• 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 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 ×10⁹/L);
• Pregnant patients

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; This arm will receive the standard of care as per the hospital guidelines.	Drug: Standard of care; Standard of care treatment as per the hospital guidelines
Experimental: Investigational treatment; This arm will receive combination of nutritional supplements quercetin and curcumin as add-on to the standard of care.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Testing negative for SARS-CoV-2 by Reverse Transcription Polymerase Chain Reaction (RT-PCR)	Testing of naso-pharyngeal swab for COVID-19	Day 7
COVID-19 symptoms improvement	Improvement of the typical symptoms associated with COVID-19 infection	Day 7

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement in CRP level	Improvement in the CRP levels	Day 7
Improvement in D-dimers level	Improvement in D-dimers level	Day 7
Improvement in LDH levels	Improvement in LDH levels	Day 7
Improvement in ferritin levels	Improvement in Ferritin levels	Day 7
Improvement in full blood count (CBC)	Improvement in CBC levels	Day 7

Collaborators and Investigators

• Sponsor: King Edward Medical University

Publications and helpful links

General Publications

• Khan A, Iqtadar S, Mumtaz SU, Heinrich M, Pascual-Figal DA, Livingstone S, Abaidullah S. Oral Co-Supplementation of Curcumin, Quercetin, and Vitamin D3 as an Adjuvant Therapy for Mild to Moderate Symptoms of COVID-19-Results From a Pilot Open-Label, Randomized Controlled Trial. Front Pharmacol. 2022 Jun 7;13:898062. doi: 10.3389/fphar.2022.898062. eCollection 2022.

Study record dates

Study Major Dates

• Study Start (Actual): October 25, 2021
• Primary Completion (Actual): December 31, 2021
• Study Completion (Actual): December 31, 2021

Study Registration Dates

• First Submitted: November 21, 2021
• First Submitted That Met QC Criteria: November 21, 2021
• First Posted (Actual): November 23, 2021

Study Record Updates

• Last Update Posted (Actual): January 28, 2022
• Last Update Submitted That Met QC Criteria: January 13, 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
• Other Study ID Numbers: 785/RC/KEMU/25.10.2021

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No