Oral Curcumin, Quercetin and Vitamin D3 Supplements for Mild to Moderate Symptoms of COVID-19

Study Overview
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Brief Summary
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The present study is aimed to investigate the treatment benefits of a combination of dietary supplements quercetin, curcumin and vitamin D3 as add-on therapy to the routine care for early mild symptoms of COVID-19 infection in outpatients setting.

Detailed Description
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There is currently no specific early-stage therapeutic treatment available for COVID-19. Dietary supplements curcumin, quercetin and vitamin D3 have shown strong antioxidant, anti-inflammatory/immunomodulatory and broad-spectrum antiviral effects. The present study is focused to test the combination of oral curcumin, quercetin and vitamin D3 supplements as complementary therapy for outpatients with mild to moderate symptoms of COVID-19 infection.

Official Title
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Complementary Therapy of Dietary Supplements Curcumin, Quercetin and Vitamin D3 for Mild to Moderate Symptoms of COVID-19

Conditions
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Covid-19

Intervention / Treatment
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* Dietary Supplement: Complementary therapy
* Drug: Standard of care


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 within 72 hours prior to enrolment 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 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 suffering 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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Pilot, randomized, controlled, open-label and pragmatic trial, comparing the treatment benefits of combination of curcumin, quercetin and vitamin D3 supplements as add-on to standard treatment vs. standard therapy, in mild to moderate symptomatic COVID-19 outpatients, within 48 hours, for testing Positive for SARS-CoV-2.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Complementary therapy group<br>This arm will receive a daily supplementation of 168 mg curcumin, 260 mg quercetin and 9 mcg/360 IU of vitamin D3 (cholecalciferol) as add-on to the standard of care for 14-days | Dietary Supplement: Complementary therapy<br>* A daily supplementation of 168 mg curcumin, 260 mg quercetin and 360 IU of vitamin D3 (cholecalciferol) for 14-days<br>Drug: Standard of care<br>* This arm will receive standard of care as per the hospital guidelines<br>|
| Active Comparator: Control group<br>This arm will receive standard care alone | Drug: Standard of care<br>* This arm will receive standard of care as per the hospital guidelines<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SARS-CoV-2 Negativity by RT-PCR | Number of patients testing negative for COVID-19 | up to 14 days | 
| COVID-19 symptoms improvement | Number of patients with improvement in COVID-19 acute symptoms | up to 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in the serum inflammatory marker level | Changes in the serum CRP level | up to 7 days | 
| Improvement in the serum inflammatory marker level | Changes in the serum D-dimer level | up to 7 days | 
| Improvement in the serum inflammatory marker level | Changes in the serum LDH level | up to 7 days | 
| Improvement in the serum inflammatory marker level | Changes in the serum ferritin level | up to 7 days | 
| Hospitalization rate | Number of patients required hospitalization | up to 14 days | 
| Length of hospitalization | Number of hospital admission days | up to 14 days | 
| Length of supplementary oxygen therapy | Patients requirement oxygen at during hospitalization | up to 14 days | 
| ICU transfer | Numbers of patients progressing to ICU | up to 14 days | 
| Mechanical ventilation | Numbers of patients requiring mechanical ventilation at hospital | up to 14 days | 
| All cause mortality | Numbers of hospital mortality | up to 14 days | 
| Safety and tolerability | Any adverse event due to the investigational treatment | up to 14 days |