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

COVID-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04578158
• Other study ID #: LUMHS/REC/894
• Status: Completed
• Phase: Phase 3
• Start date: September 29, 2020
• Est. completion date: April 15, 2021

Study information

• Verified date: April 2021
• Source: Liaquat University of Medical & Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 152
• Est. completion date: April 15, 2021
• Est. primary completion date: March 28, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19

Intervention

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

Locations

Country	Name	City	State
Pakistan	Liaquat University Hospital	Jamshoro	Sindh

Sponsors (1)

Lead Sponsor	Collaborator
Liaquat University of Medical & Health Sciences

Country where clinical trial is conducted

Pakistan, 

References & Publications (3)

Abian O, Ortega-Alarcon D, Jimenez-Alesanco A, Ceballos-Laita L, Vega S, Reyburn HT, Rizzuti B, Velazquez-Campoy A. Structural stability of SARS-CoV-2 3CLpro and identification of quercetin as an inhibitor by experimental screening. Int J Biol Macromol. 2 — View Citation

Colunga Biancatelli RML, Berrill M, Catravas JD, Marik PE. Quercetin and Vitamin C: An Experimental, Synergistic Therapy for the Prevention and Treatment of SARS-CoV-2 Related Disease (COVID-19). Front Immunol. 2020 Jun 19;11:1451. doi: 10.3389/fimmu.2020 — View Citation

Liu X, Raghuvanshi R, Ceylan FD, Bolling BW. Quercetin and Its Metabolites Inhibit Recombinant Human Angiotensin-Converting Enzyme 2 (ACE2) Activity. J Agric Food Chem. 2020 Nov 25;68(47):13982-13989. doi: 10.1021/acs.jafc.0c05064. Epub 2020 Nov 12. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of subjects with COVID-19 disease progression	Percentage of subjects who require hospitalisation	From day 1 to day 30