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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04578158
Recruitment Status : Completed
First Posted : October 8, 2020
Last Update Posted : April 22, 2021
Sponsor:
Information provided by (Responsible Party):
Prof. Dr. Ikram Din Ujjan, MBBS, PhD, 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.

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.

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Study Type : Interventional  (Clinical Trial)
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 : September 29, 2020
Actual Primary Completion Date : March 28, 2021
Actual Study Completion Date : April 15, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Quercetin

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




Primary Outcome Measures :
  1. Percentage of subjects with COVID-19 disease progression [ Time Frame: From day 1 to day 30 ]
    Percentage of subjects who require hospitalisation



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04578158


Locations
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Pakistan
Liaquat University Hospital
Jāmshoro, Sindh, Pakistan, 76090
Sponsors and Collaborators
Liaquat University of Medical & Health Sciences
Publications of Results:
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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: October 8, 2020    Key Record Dates
Last Update Posted: April 22, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Prof. Dr. Ikram Din Ujjan, MBBS, PhD, Liaquat University of Medical & Health Sciences:
COVID-19, Quercetin Phytosome, Anti-inflammatory, Immunomodulatory, Respiratory distress
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Quercetin
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs