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

Not Applicable

Completed

• Conditions: Covid-19
• Interventions: Dietary Supplement: Complementary therapy; Drug: Standard of care

• Registration Number: NCT04603690
• Lead Sponsor: Liaquat University of Medical & Health Sciences

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.

Study Timeline

• Study First Submitted: 2020-10-24
• Study First Submitted QC: 2020-10-24
• Study First Posted: 2020-10-27
• Study Start: 2021-08-16
• Primary Completion: 2022-01-31
• Study Completion: 2022-02-28
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-22
• Last Update Posted: 2022-03-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Complementary therapy group	Complementary therapy	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
Control group	Standard of care	This arm will receive standard care alone
Complementary therapy group	Standard of care	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

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Liaquat University Hospital; 🇵🇰 Jāmshoro, Sindh, Pakistan