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

Sponsor

Liaquat University of Medical & Health Sciences (Other)

Overall Status

Completed

CT.gov ID

NCT04578158

Collaborator

(none)

152

Enrollment

Location

Arms

6.5

Actual Duration (Months)

23.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
COVID-19	Drug: Standard COVID-19 care Dietary Supplement: Quercetin Phytosome	Phase 3

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 Design

Study Type:

Interventional

Actual Enrollment :

152 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Sep 29, 2020

Actual Primary Completion Date :

Mar 28, 2021

Actual Study Completion Date :

Apr 15, 2021

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Percentage of subjects with COVID-19 disease progression [From day 1 to day 30]
Percentage of subjects who require hospitalisation

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Liaquat University Hospital	Jāmshoro	Sindh	Pakistan	76090

Sponsors and Collaborators

Liaquat University of Medical & Health Sciences

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Prof. Dr. Ikram Din Ujjan, MBBS, PhD, Principal Investigator, Liaquat University of Medical & Health Sciences

ClinicalTrials.gov Identifier:

NCT04578158

Other Study ID Numbers:

LUMHS/REC/894

First Posted:

Oct 8, 2020

Last Update Posted:

Apr 22, 2021

Last Verified:

Apr 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Prof. Dr. Ikram Din Ujjan, MBBS, PhD, Principal Investigator, Liaquat University of Medical & Health Sciences

COVID-19, Quercetin Phytosome, Anti-inflammatory, Immunomodulatory, Respiratory distress

Additional relevant MeSH terms:

COVID-19

Quercetin

Study Results

No Results Posted as of Apr 22, 2021