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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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COVID-19

Intervention / Treatment
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* Drug: Standard of care
* Dietary Supplement: Investigational treatment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard of care<br>This arm will receive the standard of care as per the hospital guidelines. | Drug: Standard of care<br>* Standard of care treatment as per the hospital guidelines<br>|
| Experimental: Investigational treatment<br>This arm will receive combination of nutritional supplements quercetin and curcumin as add-on to the standard of care. | Drug: Standard of care<br>* Standard of care treatment as per the hospital guidelines<br>Dietary Supplement: Investigational treatment<br>* Combination of quercetin and curcumin as add-on to the standard of care<br>|

What is the study measuring?
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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 |