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
Sponsored by
About this trial
This is an interventional treatment trial for COVID-19
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
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 D-dimers level
Improvement in LDH levels
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
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 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
No
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
Learn more about this trial
Nutritional Supplementation of Flavonoids Quercetin and Curcumin for Early Mild Symptoms of COVID-19
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