Trial to Study the Adjuvant Benefits of Quercetin Phytosome in Patients With COVID-19

Study Overview
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Brief Summary
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The purpose of this study is to investigate if Quercetin Phytosome is beneficial for the treatment of COVID-19.

Detailed Description
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This is a randomized, open-labelled and controlled study aimed to investigate the adjuvant benefits of Quercetin Phytosome in community-based subjects with confirmed SARS-CoV-2 infection (by RT-PCR). The study has two arms. In one arm the subjects will receive standard COVID-19 care as per the hospital/physician guidelines, whereas in the other arm the subjects will receive standard COVID-19 care + Quercetin Phytosome. The treatment will continue for 30 days. It is proposed that Quercetin Phytosome will contribute to boosting the natural immunity of the subjects and will help in preventing the COVID-19 disease progression i.e preventing the need of hospitalisation.

Official Title
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A Prospective, Randomized, Open-labelled, Controlled Trial to Study the Adjuvant Benefits of Quercetin Phytosome in Patients With Diagnosis of COVID-19.

Conditions
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COVID-19

Intervention / Treatment
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* Drug: Standard COVID-19 care
* Dietary Supplement: Quercetin Phytosome


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 years of either gender Confirmed SARS-CoV-2 infection by RT-PCR Currently diagnosed with mild-to-moderate symptoms of COVID-19 at home in self-isolation within 3 days of SARS-CoV-2 infection. Displaying typical symptoms of COVID-19 such as a high temperature, a new, continuous cough, a loss or change to sense of smell or taste Patients who have signed informed consent. Exclusion Criteria: Patients with proven hypersensitivity or allergic reaction to quercetin Manifest contrary will

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 COVID-19 care as per the hospital physician guidelines. | Drug: Standard COVID-19 care<br>* Patients will receive standard covid-19 care as per the hospital/physician guidelines<br>|
| Experimental: Quercetin Phytosome<br>This arm will receive standard COVID-19 care + Quercetin Phytosome | Drug: Standard COVID-19 care<br>* Patients will receive standard covid-19 care as per the hospital/physician guidelines<br>Dietary Supplement: Quercetin Phytosome<br>* Patients will receive a daily dose of 400 mg of oral Quercetin Phytosome<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of subjects with COVID-19 disease progression | Percentage of subjects who require hospitalisation | From day 1 to day 30 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COVID-19, Quercetin Phytosome, Anti-inflammatory, Immunomodulatory, Respiratory distress