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

Sponsor

King Edward Medical University (Other)

Overall Status

Completed

CT.gov ID

NCT05130671

Collaborator

(none)

Enrollment

Location

Arms

2.2

Actual Duration (Months)

22.7

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
COVID-19	Drug: Standard of care Dietary Supplement: Investigational treatment	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Oct 25, 2021

Actual Primary Completion Date :

Dec 31, 2021

Actual Study Completion Date :

Dec 31, 2021

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Improvement in CRP level [Day 7]
Improvement in the CRP levels
Improvement in D-dimers level [Day 7]
Improvement in D-dimers level
Improvement in LDH levels [Day 7]
Improvement in LDH levels
Improvement in ferritin levels [Day 7]
Improvement in Ferritin levels
Improvement in full blood count (CBC) [Day 7]
Improvement in CBC levels

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	King Edward Medical University Teaching Hospital	Lahore	Punjab	Pakistan	54000

Sponsors and Collaborators

King Edward Medical University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

somia iqtadar, Associate Professor of Medicine, King Edward Medical University

ClinicalTrials.gov Identifier:

NCT05130671

Other Study ID Numbers:

785/RC/KEMU/25.10.2021

First Posted:

Nov 23, 2021

Last Update Posted:

Jan 28, 2022

Last Verified:

Jan 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

COVID-19

Study Results

No Results Posted as of Jan 28, 2022