Back to resultsOral Curcumin, Quercetin and Vitamin D3 Supplements for Mild to Moderate Symptoms of COVID-19
Primary Purpose
Covid-19
Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Complementary therapy
Standard of care
Sponsored by
About this trial
This is an interventional supportive care 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 within 72 hours prior to enrolment
- 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 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 suffering patients
- Patients with moderate or severe thrombocytopenia (platelet count <100 ×10⁹/L);
- Pregnant patients
Sites / Locations
- Liaquat University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Complementary therapy group
Control group
Arm Description
This arm will receive a daily supplementation of 168 mg curcumin, 260 mg quercetin and 9 mcg/360 IU of vitamin D3 (cholecalciferol) as add-on to the standard of care for 14-days
This arm will receive standard care alone
Outcomes
Primary Outcome Measures
SARS-CoV-2 Negativity by RT-PCR
Number of patients testing negative for COVID-19
COVID-19 symptoms improvement
Number of patients with improvement in COVID-19 acute symptoms
Secondary Outcome Measures
Improvement in the serum inflammatory marker level
Changes in the serum CRP level
Improvement in the serum inflammatory marker level
Changes in the serum D-dimer level
Improvement in the serum inflammatory marker level
Changes in the serum LDH level
Improvement in the serum inflammatory marker level
Changes in the serum ferritin level
Hospitalization rate
Number of patients required hospitalization
Length of hospitalization
Number of hospital admission days
Length of supplementary oxygen therapy
Patients requirement oxygen at during hospitalization
ICU transfer
Numbers of patients progressing to ICU
Mechanical ventilation
Numbers of patients requiring mechanical ventilation at hospital
All cause mortality
Numbers of hospital mortality
Safety and tolerability
Any adverse event due to the investigational treatment
Full Information
NCT ID
NCT04603690
First Posted
October 24, 2020
Last Updated
March 22, 2022
Sponsor
Liaquat University of Medical & Health Sciences
1. Study Identification
Unique Protocol Identification Number
NCT04603690
Brief Title
Oral Curcumin, Quercetin and Vitamin D3 Supplements for Mild to Moderate Symptoms of COVID-19
Official Title
Complementary Therapy of Dietary Supplements Curcumin, Quercetin and Vitamin D3 for Mild to Moderate Symptoms of COVID-19
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
August 16, 2021 (Actual)
Primary Completion Date
January 31, 2022 (Actual)
Study Completion Date
February 28, 2022 (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
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The present study is aimed to investigate the treatment benefits of a combination of dietary supplements quercetin, curcumin and vitamin D3 as add-on therapy to the routine care for early mild symptoms of COVID-19 infection in outpatients setting.
Detailed Description
There is currently no specific early-stage therapeutic treatment available for COVID-19.
Dietary supplements curcumin, quercetin and vitamin D3 have shown strong antioxidant, anti-inflammatory/immunomodulatory and broad-spectrum antiviral effects. The present study is focused to test the combination of oral curcumin, quercetin and vitamin D3 supplements as complementary therapy for outpatients with mild to moderate symptoms of COVID-19 infection.
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
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Pilot, randomized, controlled, open-label and pragmatic trial, comparing the treatment benefits of combination of curcumin, quercetin and vitamin D3 supplements as add-on to standard treatment vs. standard therapy, in mild to moderate symptomatic COVID-19 outpatients, within 48 hours, for testing Positive for SARS-CoV-2.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Complementary therapy group
Arm Type
Experimental
Arm Description
This arm will receive a daily supplementation of 168 mg curcumin, 260 mg quercetin and 9 mcg/360 IU of vitamin D3 (cholecalciferol) as add-on to the standard of care for 14-days
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
This arm will receive standard care alone
Intervention Type
Dietary Supplement
Intervention Name(s)
Complementary therapy
Intervention Description
A daily supplementation of 168 mg curcumin, 260 mg quercetin and 360 IU of vitamin D3 (cholecalciferol) for 14-days
Intervention Type
Drug
Intervention Name(s)
Standard of care
Intervention Description
This arm will receive standard of care as per the hospital guidelines
Primary Outcome Measure Information:
Title
SARS-CoV-2 Negativity by RT-PCR
Description
Number of patients testing negative for COVID-19
Time Frame
up to 14 days
Title
COVID-19 symptoms improvement
Description
Number of patients with improvement in COVID-19 acute symptoms
Time Frame
up to 7 days
Secondary Outcome Measure Information:
Title
Improvement in the serum inflammatory marker level
Description
Changes in the serum CRP level
Time Frame
up to 7 days
Title
Improvement in the serum inflammatory marker level
Description
Changes in the serum D-dimer level
Time Frame
up to 7 days
Title
Improvement in the serum inflammatory marker level
Description
Changes in the serum LDH level
Time Frame
up to 7 days
Title
Improvement in the serum inflammatory marker level
Description
Changes in the serum ferritin level
Time Frame
up to 7 days
Title
Hospitalization rate
Description
Number of patients required hospitalization
Time Frame
up to 14 days
Title
Length of hospitalization
Description
Number of hospital admission days
Time Frame
up to 14 days
Title
Length of supplementary oxygen therapy
Description
Patients requirement oxygen at during hospitalization
Time Frame
up to 14 days
Title
ICU transfer
Description
Numbers of patients progressing to ICU
Time Frame
up to 14 days
Title
Mechanical ventilation
Description
Numbers of patients requiring mechanical ventilation at hospital
Time Frame
up to 14 days
Title
All cause mortality
Description
Numbers of hospital mortality
Time Frame
up to 14 days
Title
Safety and tolerability
Description
Any adverse event due to the investigational treatment
Time Frame
up to 14 days
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 within 72 hours prior to enrolment
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 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 suffering patients
Patients with moderate or severe thrombocytopenia (platelet count <100 ×10⁹/L);
Pregnant patients
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
Learn more about this trial
Oral Curcumin, Quercetin and Vitamin D3 Supplements for Mild to Moderate Symptoms of COVID-19
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