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

April 21, 2021 updated by: Prof. Dr. Ikram Din Ujjan, MBBS, PhD, Liaquat University of Medical & Health Sciences

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

152

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Sindh
      • Jāmshoro, Sindh, Pakistan, 76090
        • Liaquat University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Standard of care
This arm will receive the standard COVID-19 care as per the hospital physician guidelines.
Drug: Standard COVID-19 care
Patients will receive standard covid-19 care as per the hospital/physician guidelines
Experimental: Quercetin Phytosome
This arm will receive standard COVID-19 care + Quercetin Phytosome
Drug: Standard COVID-19 care
Patients will receive standard covid-19 care as per the hospital/physician guidelines
Dietary supplement: Quercetin Phytosome
Patients will receive a daily dose of 400 mg of oral Quercetin Phytosome

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Liaquat University of Medical & Health Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 29, 2020

Primary Completion (Actual)

March 28, 2021

Study Completion (Actual)

April 15, 2021

Study Registration Dates

First Submitted

October 6, 2020

First Submitted That Met QC Criteria

October 6, 2020

First Posted (Actual)

October 8, 2020

Study Record Updates

Last Update Posted (Actual)

April 22, 2021

Last Update Submitted That Met QC Criteria

April 21, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LUMHS/REC/894

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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