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Completed

NCT Number: NCT04578158

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

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

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Key information

Conditions

COVID-19 Coronaviridae Infections Coronavirus Infections Dyspnea Infections Lung Diseases Nidovirales Infections Pathological Conditions, Signs and Symptoms Pneumonia Pneumonia, Viral RNA Virus Infections Respiration Disorders Respiratory Tract Diseases Respiratory Tract Infections Signs and Symptoms Signs and Symptoms, Respiratory Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Liaquat University Hospital

Jāmshoro, Sindh, 76090, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Standard COVID-19 care

Drug

Patients will receive standard covid-19 care as per the hospital/physician guidelines

Quercetin Phytosome

Dietary Supplement

Patients will receive a daily dose of 400 mg of oral Quercetin Phytosome

Primary outcomes

  1. Percentage of subjects with COVID-19 disease progression

    Time frame: From day 1 to day 30

    Percentage of subjects who require hospitalisation

Sponsors and collaborators

Lead sponsor

Liaquat University of Medical & Health Sciences

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Oct 8, 2020
Registry last updated
Apr 22, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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