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

Covid-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04603690
• Other study ID #: LUMHS/REC/173
• Status: Completed
• Phase: N/A
• Start date: August 16, 2021
• Est. completion date: February 28, 2022

Study information

• Verified date: March 2022
• Source: Liaquat University of Medical & Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: February 28, 2022
• Est. primary completion date: January 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 ×10?/L);
• Pregnant patients

Related Conditions & MeSH terms

• Covid-19

Intervention

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

Locations

Country	Name	City	State
Pakistan	Liaquat University Hospital	Jamshoro	Sindh

Sponsors (1)

Lead Sponsor	Collaborator
Liaquat University of Medical & Health Sciences

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	SARS-CoV-2 Negativity by RT-PCR	Number of patients testing negative for COVID-19	up to 14 days
Primary	COVID-19 symptoms improvement	Number of patients with improvement in COVID-19 acute symptoms	up to 7 days
Secondary	Improvement in the serum inflammatory marker level	Changes in the serum CRP level	up to 7 days
Secondary	Improvement in the serum inflammatory marker level	Changes in the serum D-dimer level	up to 7 days
Secondary	Improvement in the serum inflammatory marker level	Changes in the serum LDH level	up to 7 days
Secondary	Improvement in the serum inflammatory marker level	Changes in the serum ferritin level	up to 7 days
Secondary	Hospitalization rate	Number of patients required hospitalization	up to 14 days
Secondary	Length of hospitalization	Number of hospital admission days	up to 14 days
Secondary	Length of supplementary oxygen therapy	Patients requirement oxygen at during hospitalization	up to 14 days
Secondary	ICU transfer	Numbers of patients progressing to ICU	up to 14 days
Secondary	Mechanical ventilation	Numbers of patients requiring mechanical ventilation at hospital	up to 14 days
Secondary	All cause mortality	Numbers of hospital mortality	up to 14 days
Secondary	Safety and tolerability	Any adverse event due to the investigational treatment	up to 14 days