NCT04861298

Brief Summary

Quercetin is a flavonoid dietary supplement that occurs in many edible fruits and vegetables. It has remarkable antioxidant, anti-inflammatory, immunoprotective and antiviral properties. It is widely used to boost the body immune system against infections and keeping healthy life-style. The purpose of the present study is to investigate the potential benefits of quercetin for preventing COVID-19 disease progression and symptoms improvement in the early stage of infection.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable covid19

Timeline
Completed

Started Jan 2021

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

January 11, 2021

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 25, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 27, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 29, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 29, 2021

Completed
Last Updated

February 7, 2022

Status Verified

January 1, 2022

Enrollment Period

8 months

First QC Date

April 25, 2021

Last Update Submit

January 23, 2022

Conditions

COVID-19

Outcome Measures

Primary Outcomes (1)

  • Testing negative for SARS-CoV-2 by RT-PCR with symptoms improvement

    From day 1 to day 14

Secondary Outcomes (6)

  • Percentage of subjects that require hospitalisation

    From day 1 to day 14

  • Improvement in CRP

    From day 1 to day 14

  • Improvement in D-Dimers

    From day 1 to day 14

  • Improvement in LDH

    From day 1 to day 14

  • Improvement in Ferritin

    From day 1 to day 14

  • +1 more secondary outcomes

Study Arms (2)

Standard of care (SOC)

ACTIVE COMPARATOR

This arm will receive the standard of care (SOC) for COVID-19 as per the hospital guidelines.

Drug: standard of care for COVID-19 as per the hospital guidelines

Quercetin

EXPERIMENTAL

This arm will receive standard of care + oral Quercetin for two weeks

Drug: standard of care for COVID-19 as per the hospital guidelinesDietary Supplement: Quercetin Phytosome (QP)

Interventions

standard of care for COVID-19 as per the hospital guidelinesDRUG

Hospital standard of care treatment for COVID-19

QuercetinStandard of care (SOC)
Quercetin Phytosome (QP)DIETARY_SUPPLEMENT

Daily dose of 600 mg of Quercetin for 1st week and then 400 mg for the 2nd week

Quercetin

Eligibility Criteria

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

You may qualify if:

  • Patients must be 18 years of age or older, of either gender
  • Patients must be tested positive for SARS-CoV-2 by RT-PCR
  • Patients must exhibit typical symptoms of COVID-19 disease at screening such as fever, fatigue, a dry and contagious cough, loss of appetite, body aches, shortness of breath, mucus or phlegm, sore throat, headache, chills, sometimes with shaking, loss of smell or taste, congestion or runny nose, nausea, or vomiting, diarrhea, muscular pain etc.
  • Patients must be in the early stage of COVID-19 disease who do not require hospitalisation at the time of screening
  • Patients must be under the care of a Physician for diagnosis of COVID-19
  • Patients who have signed informed consent

You may not qualify if:

  • Patients with proven hypersensitivity or allergic reaction to quercetin
  • Patients with known chronic kidney disease with estimated creatinine clearance \< 50 mL/minute or need for dialysis
  • Patients who are severely hypotensive defined as needing hemodynamic pressors to maintain blood pressure
  • Patients with moderate or severe thrombocytopenia (platelet count \<100 × 10⁹/L);
  • Pregnant patients
  • Patients declining to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

King Edward Medical University Teaching Hospital

Lahore, Punjab Province, 54000, Pakistan

Location

Related Publications (1)

  • Di Pierro F, Khan A, Iqtadar S, Mumtaz SU, Chaudhry MNA, Bertuccioli A, Derosa G, Maffioli P, Togni S, Riva A, Allegrini P, Recchia M, Zerbinati N. Quercetin as a possible complementary agent for early-stage COVID-19: Concluding results of a randomized clinical trial. Front Pharmacol. 2023 Jan 13;13:1096853. doi: 10.3389/fphar.2022.1096853. eCollection 2022.

    PMID: 36712674DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 25, 2021

First Posted

April 27, 2021

Study Start

January 11, 2021

Primary Completion

August 29, 2021

Study Completion

August 29, 2021

Last Updated

February 7, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)