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Nutritional Supplementation of Flavonoids Quercetin and Curcumin for Early Mild Symptoms of COVID-19

Primary Purpose

COVID-19

Status

Completed

Phase

Not Applicable

Locations

Pakistan

Study Type

Interventional

Intervention

Standard of care

Investigational treatment

About this trial

This is an interventional treatment trial for COVID-19

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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 withshaking, 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 hospitalization 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

Exclusion Criteria:

Patients with proven hypersensitivity or allergic reaction to quercetin or curcumin
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 taking anticoagulant/antiplatelet drugs such as Coumarine, Heparine, Aspirin, Clopidrogel, dalteparin, enoxaparin, ticlopidine and warparin.
Patients with gallstone obstruction
Hypothyroid suppering patients
Patients with moderate or severe thrombocytopenia (platelet count <100 ×10⁹/L);
Pregnant patients

Sites / Locations

King Edward Medical University Teaching Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard of care

Investigational treatment

Arm Description

This arm will receive the standard of care as per the hospital guidelines.

This arm will receive combination of nutritional supplements quercetin and curcumin as add-on to the standard of care.

Outcomes

Primary Outcome Measures

Testing negative for SARS-CoV-2 by Reverse Transcription Polymerase Chain Reaction (RT-PCR)

Testing of naso-pharyngeal swab for COVID-19

COVID-19 symptoms improvement

Improvement of the typical symptoms associated with COVID-19 infection

Secondary Outcome Measures

Improvement in CRP level

Improvement in the CRP levels

Improvement in D-dimers level

Improvement in LDH levels

Improvement in ferritin levels

Improvement in Ferritin levels

Improvement in full blood count (CBC)

Improvement in CBC levels

Full Information

NCT ID

NCT05130671

First Posted

November 21, 2021

Last Updated

January 13, 2022

Sponsor

King Edward Medical University

1. Study Identification

Unique Protocol Identification Number

NCT05130671

Brief Title

Nutritional Supplementation of Flavonoids Quercetin and Curcumin for Early Mild Symptoms of COVID-19

Official Title

Treatment Benefits of Flavonoids Quercetin and Curcumin Supplements for Mild Symptoms of COVID-19

Study Type

Interventional

2. Study Status

Record Verification Date

January 2022

Overall Recruitment Status

Completed

Study Start Date

October 25, 2021 (Actual)

Primary Completion Date

December 31, 2021 (Actual)

Study Completion Date

December 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

King Edward Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The purpose of this study is to investigate the therapeutic benefits of flavonoids nutritional supplements quercetin and curcumin for early mild symptoms of COVID-19.

Detailed Description

Flavonoids nutritional supplements quercetin and curcumin have demonstrated strong antioxidant, broad-spectrum anti-viral and anti-inflammatory properties including against the respiratory tract infections. They are widely used to boost the immunity against infections and keeping healthy life-style. Results from recent published studies have shown positive results for quercetin and curcumin in patients with COVID-19. In the present study the investigators aim to study the combined beneficial effects of quercetin and curcumin in addition to standard of care for managing early mild symptoms of COVID-19 in community-based patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

COVID-19

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

50 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Standard of care

Arm Type

Active Comparator

Arm Description

This arm will receive the standard of care as per the hospital guidelines.

Arm Title

Investigational treatment

Arm Type

Experimental

Arm Description

This arm will receive combination of nutritional supplements quercetin and curcumin as add-on to the standard of care.

Intervention Type

Drug

Intervention Name(s)

Standard of care

Intervention Description

Standard of care treatment as per the hospital guidelines

Intervention Type

Dietary Supplement

Intervention Name(s)

Investigational treatment

Intervention Description

Combination of quercetin and curcumin as add-on to the standard of care

Primary Outcome Measure Information:

Title

Testing negative for SARS-CoV-2 by Reverse Transcription Polymerase Chain Reaction (RT-PCR)

Description

Testing of naso-pharyngeal swab for COVID-19

Time Frame

Day 7

Title

COVID-19 symptoms improvement

Description

Improvement of the typical symptoms associated with COVID-19 infection

Time Frame

Day 7

Secondary Outcome Measure Information:

Title

Improvement in CRP level

Description

Improvement in the CRP levels

Time Frame

Day 7

Title

Improvement in D-dimers level

Description

Improvement in D-dimers level

Time Frame

Day 7

Title

Improvement in LDH levels

Description

Improvement in LDH levels

Time Frame

Day 7

Title

Improvement in ferritin levels

Description

Improvement in Ferritin levels

Time Frame

Day 7

Title

Improvement in full blood count (CBC)

Description

Improvement in CBC levels

Time Frame

Day 7

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 withshaking, 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 hospitalization 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 Exclusion Criteria: Patients with proven hypersensitivity or allergic reaction to quercetin or curcumin 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 taking anticoagulant/antiplatelet drugs such as Coumarine, Heparine, Aspirin, Clopidrogel, dalteparin, enoxaparin, ticlopidine and warparin. Patients with gallstone obstruction Hypothyroid suppering patients Patients with moderate or severe thrombocytopenia (platelet count <100 ×10⁹/L); Pregnant patients

Facility Information:

Facility Name

King Edward Medical University Teaching Hospital

City

Lahore

State/Province

Punjab

ZIP/Postal Code

54000

Country

Pakistan

12. IPD Sharing Statement

Citations:

PubMed Identifier

35747751

Citation

Khan A, Iqtadar S, Mumtaz SU, Heinrich M, Pascual-Figal DA, Livingstone S, Abaidullah S. Oral Co-Supplementation of Curcumin, Quercetin, and Vitamin D3 as an Adjuvant Therapy for Mild to Moderate Symptoms of COVID-19-Results From a Pilot Open-Label, Randomized Controlled Trial. Front Pharmacol. 2022 Jun 7;13:898062. doi: 10.3389/fphar.2022.898062. eCollection 2022.

Results Reference

derived

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Nutritional Supplementation of Flavonoids Quercetin and Curcumin for Early Mild Symptoms of COVID-19

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