Oral Curcumin, Quercetin and Vitamin D3 Supplements for Mild to Moderate Symptoms of COVID-19

Complementary Therapy of Dietary Supplements Curcumin, Quercetin and Vitamin D3 for Mild to Moderate Symptoms of COVID-19

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.

Study Overview

• Status: Completed
• Conditions: Covid-19
• Intervention / Treatment: Dietary supplement: Complementary therapy; Drug: Standard of care

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.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Sindh
    • Jāmshoro, Sindh, Pakistan, 76090
      • Liaquat University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Complementary therapy group; 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	Dietary supplement: Complementary therapy; A daily supplementation of 168 mg curcumin, 260 mg quercetin and 360 IU of vitamin D3 (cholecalciferol) for 14-days; Drug: Standard of care; This arm will receive standard of care as per the hospital guidelines
Active Comparator: Control group; This arm will receive standard care alone	Drug: Standard of care; This arm will receive standard of care as per the hospital guidelines

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
SARS-CoV-2 Negativity by RT-PCR	Number of patients testing negative for COVID-19	up to 14 days
COVID-19 symptoms improvement	Number of patients with improvement in COVID-19 acute symptoms	up to 7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement in the serum inflammatory marker level	Changes in the serum CRP level	up to 7 days
Improvement in the serum inflammatory marker level	Changes in the serum D-dimer level	up to 7 days
Improvement in the serum inflammatory marker level	Changes in the serum LDH level	up to 7 days
Improvement in the serum inflammatory marker level	Changes in the serum ferritin level	up to 7 days
Hospitalization rate	Number of patients required hospitalization	up to 14 days
Length of hospitalization	Number of hospital admission days	up to 14 days
Length of supplementary oxygen therapy	Patients requirement oxygen at during hospitalization	up to 14 days
ICU transfer	Numbers of patients progressing to ICU	up to 14 days
Mechanical ventilation	Numbers of patients requiring mechanical ventilation at hospital	up to 14 days
All cause mortality	Numbers of hospital mortality	up to 14 days
Safety and tolerability	Any adverse event due to the investigational treatment	up to 14 days

Collaborators and Investigators

• Sponsor: Liaquat University of Medical & Health Sciences

Study record dates

Study Major Dates

• Study Start (Actual): August 16, 2021
• Primary Completion (Actual): January 31, 2022
• Study Completion (Actual): February 28, 2022

Study Registration Dates

• First Submitted: October 24, 2020
• First Submitted That Met QC Criteria: October 24, 2020
• First Posted (Actual): October 27, 2020

Study Record Updates

• Last Update Posted (Actual): March 23, 2022
• Last Update Submitted That Met QC Criteria: March 22, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: LUMHS/REC/173

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• 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