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

NCT04603690 | Completed DMC

• 1 other identifier: LUMHS/REC/173
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Covid-19

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (11)

• Improvement in the serum inflammatory marker level

  up to 7 days

• Improvement in the serum inflammatory marker level

  up to 7 days

• Improvement in the serum inflammatory marker level

  up to 7 days

• Improvement in the serum inflammatory marker level

  up to 7 days

• Hospitalization rate

  up to 14 days

Study Arms (2)

Complementary therapy group

EXPERIMENTAL

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; Drug: Standard of care

Control group

ACTIVE COMPARATOR

This arm will receive standard care alone

Drug: Standard of care

Interventions

Complementary therapy DIETARY_SUPPLEMENT

A daily supplementation of 168 mg curcumin, 260 mg quercetin and 360 IU of vitamin D3 (cholecalciferol) for 14-days

Complementary therapy group

Standard of care DRUG

This arm will receive standard of care as per the hospital guidelines

Complementary therapy group; Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Liaquat University of Medical & Health Sciences: lead

Study Sites (1)

Liaquat University Hospital

Jāmshoro, Sindh, 76090, Pakistan

Location

Related Publications (1)

• Ujjan ID, Khan S, Nigar R, Ahmed H, Ahmad S, Khan A. The possible therapeutic role of curcumin and quercetin in the early-stage of COVID-19-Results from a pragmatic randomized clinical trial. Front Nutr. 2023 Jan 18;9:1023997. doi: 10.3389/fnut.2022.1023997. eCollection 2022.

  PMID: 36742008 DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

Complementary Therapies; Standard of Care

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Pathology

Model Details: 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.

Study Record Dates

• First Submitted: October 24, 2020
• First Posted: October 27, 2020
• Study Start: August 16, 2021
• Primary Completion: January 31, 2022
• Study Completion: February 28, 2022
• Last Updated: March 23, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)