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

Phase 3

Completed

• Conditions: COVID-19
• Interventions: Drug: Standard COVID-19 care; Dietary Supplement: Quercetin Phytosome

• Registration Number: NCT04578158
• Lead Sponsor: Liaquat University of Medical & Health Sciences

Brief Summary

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

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 Timeline

• Study Start: 2020-09-29
• Study First Submitted: 2020-10-06
• Study First Submitted QC: 2020-10-06
• Study First Posted: 2020-10-08
• Primary Completion: 2021-03-28
• Status Verified: 2021-04
• Study Completion: 2021-04-15
• Last Update Submitted: 2021-04-21
• Last Update Posted: 2021-04-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 152

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard of care	Standard COVID-19 care	This arm will receive the standard COVID-19 care as per the hospital physician guidelines.
Quercetin Phytosome	Standard COVID-19 care	This arm will receive standard COVID-19 care + Quercetin Phytosome
Quercetin Phytosome	Quercetin Phytosome	This arm will receive standard COVID-19 care + Quercetin Phytosome

Primary Outcome Measures

Name	Time	Method
Percentage of subjects with COVID-19 disease progression	From day 1 to day 30	Percentage of subjects who require hospitalisation

Trial Locations

Locations (1)

Liaquat University Hospital; 🇵🇰 Jāmshoro, Sindh, Pakistan