Trial to Study the Adjuvant Benefits of Quercetin Phytosome in Patients With COVID-19
Primary Purpose
COVID-19
Status
Completed
Phase
Phase 3
Locations
Pakistan
Study Type
Interventional
Intervention
Standard COVID-19 care
Quercetin Phytosome
Sponsored by
About this trial
This is an interventional treatment trial for COVID-19 focused on measuring COVID-19, Quercetin Phytosome, Anti-inflammatory, Immunomodulatory, Respiratory distress
Eligibility Criteria
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
Sites / Locations
- Liaquat University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Standard of care
Quercetin Phytosome
Arm Description
This arm will receive the standard COVID-19 care as per the hospital physician guidelines.
This arm will receive standard COVID-19 care + Quercetin Phytosome
Outcomes
Primary Outcome Measures
Percentage of subjects with COVID-19 disease progression
Percentage of subjects who require hospitalisation
Secondary Outcome Measures
Full Information
NCT ID
NCT04578158
First Posted
October 6, 2020
Last Updated
April 21, 2021
Sponsor
Liaquat University of Medical & Health Sciences
1. Study Identification
Unique Protocol Identification Number
NCT04578158
Brief Title
Trial to Study the Adjuvant Benefits of Quercetin Phytosome in Patients With COVID-19
Official Title
A Prospective, Randomized, Open-labelled, Controlled Trial to Study the Adjuvant Benefits of Quercetin Phytosome in Patients With Diagnosis of COVID-19.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
September 29, 2020 (Actual)
Primary Completion Date
March 28, 2021 (Actual)
Study Completion Date
April 15, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Liaquat University of Medical & Health Sciences
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19
Keywords
COVID-19, Quercetin Phytosome, Anti-inflammatory, Immunomodulatory, Respiratory distress
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
152 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Standard of care
Arm Type
Active Comparator
Arm Description
This arm will receive the standard COVID-19 care as per the hospital physician guidelines.
Arm Title
Quercetin Phytosome
Arm Type
Experimental
Arm Description
This arm will receive standard COVID-19 care + Quercetin Phytosome
Intervention Type
Drug
Intervention Name(s)
Standard COVID-19 care
Intervention Description
Patients will receive standard covid-19 care as per the hospital/physician guidelines
Intervention Type
Dietary Supplement
Intervention Name(s)
Quercetin Phytosome
Intervention Description
Patients will receive a daily dose of 400 mg of oral Quercetin Phytosome
Primary Outcome Measure Information:
Title
Percentage of subjects with COVID-19 disease progression
Description
Percentage of subjects who require hospitalisation
Time Frame
From day 1 to day 30
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Liaquat University Hospital
City
Jāmshoro
State/Province
Sindh
ZIP/Postal Code
76090
Country
Pakistan
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
32636851
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.2020.01451. eCollection 2020.
Results Reference
result
PubMed Identifier
32745548
Citation
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.
Results Reference
result
PubMed Identifier
33179911
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.
Results Reference
result
Learn more about this trial
Trial to Study the Adjuvant Benefits of Quercetin Phytosome in Patients With COVID-19
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