NCT04578158

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
152

participants targeted

Target at P25-P50 for phase_3 covid19

Timeline
Completed

Started Sep 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 29, 2020

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

October 6, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 8, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 28, 2021

Completed
18 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2021

Completed
Last Updated

April 22, 2021

Status Verified

April 1, 2021

Enrollment Period

6 months

First QC Date

October 6, 2020

Last Update Submit

April 21, 2021

Conditions

COVID-19

Keywords

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

Outcome Measures

Primary Outcomes (1)

  • Percentage of subjects with COVID-19 disease progression

    Percentage of subjects who require hospitalisation

    From day 1 to day 30

Study Arms (2)

Standard of care

ACTIVE COMPARATOR

This arm will receive the standard COVID-19 care as per the hospital physician guidelines.

Drug: Standard COVID-19 care

Quercetin Phytosome

EXPERIMENTAL

This arm will receive standard COVID-19 care + Quercetin Phytosome

Drug: Standard COVID-19 careDietary Supplement: Quercetin Phytosome

Interventions

Standard COVID-19 careDRUG

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

Quercetin PhytosomeStandard of care
Quercetin PhytosomeDIETARY_SUPPLEMENT

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

Quercetin Phytosome

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Patients with proven hypersensitivity or allergic reaction to quercetin
  • Manifest contrary will

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Liaquat University Hospital

Jāmshoro, Sindh, 76090, Pakistan

Location

Related Publications (3)

  • 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.2020.01451. eCollection 2020.

    PMID: 32636851RESULT

  • 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. 2020 Dec 1;164:1693-1703. doi: 10.1016/j.ijbiomac.2020.07.235. Epub 2020 Aug 1.

    PMID: 32745548RESULT

  • 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.

    PMID: 33179911RESULT

MeSH Terms

Conditions

COVID-19Dyspnea

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesRespiration DisordersSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 6, 2020

First Posted

October 8, 2020

Study Start

September 29, 2020

Primary Completion

March 28, 2021

Study Completion

April 15, 2021

Last Updated

April 22, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)