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

Sponsor
Liaquat University of Medical & Health Sciences (Other)
Overall Status
Completed
CT.gov ID
NCT04603690
Collaborator
(none)
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Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Complementary therapy
  • Drug: Standard of care
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention 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.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)
Primary Purpose:
Supportive Care
Official Title:
Complementary Therapy of Dietary Supplements Curcumin, Quercetin and Vitamin D3 for Mild to Moderate Symptoms of COVID-19
Actual Study Start Date :
Aug 16, 2021
Actual Primary Completion Date :
Jan 31, 2022
Actual Study Completion Date :
Feb 28, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. SARS-CoV-2 Negativity by RT-PCR [up to 14 days]

    Number of patients testing negative for COVID-19

  2. COVID-19 symptoms improvement [up to 7 days]

    Number of patients with improvement in COVID-19 acute symptoms

Secondary Outcome Measures

  1. Improvement in the serum inflammatory marker level [up to 7 days]

    Changes in the serum CRP level

  2. Improvement in the serum inflammatory marker level [up to 7 days]

    Changes in the serum D-dimer level

  3. Improvement in the serum inflammatory marker level [up to 7 days]

    Changes in the serum LDH level

  4. Improvement in the serum inflammatory marker level [up to 7 days]

    Changes in the serum ferritin level

  5. Hospitalization rate [up to 14 days]

    Number of patients required hospitalization

  6. Length of hospitalization [up to 14 days]

    Number of hospital admission days

  7. Length of supplementary oxygen therapy [up to 14 days]

    Patients requirement oxygen at during hospitalization

  8. ICU transfer [up to 14 days]

    Numbers of patients progressing to ICU

  9. Mechanical ventilation [up to 14 days]

    Numbers of patients requiring mechanical ventilation at hospital

  10. All cause mortality [up to 14 days]

    Numbers of hospital mortality

  11. Safety and tolerability [up to 14 days]

    Any adverse event due to the investigational treatment

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Liaquat University Hospital Jāmshoro Sindh Pakistan 76090

Sponsors and Collaborators

  • Liaquat University of Medical & Health Sciences

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Prof. Dr. Ikram Din Ujjan, MBBS, PhD, Professor of Pathology, Liaquat University of Medical & Health Sciences
ClinicalTrials.gov Identifier:
NCT04603690
Other Study ID Numbers:
  • LUMHS/REC/173
First Posted:
Oct 27, 2020
Last Update Posted:
Mar 23, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 23, 2022