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Completed

NCT Number: NCT04603690

Oral Curcumin, Quercetin and Vitamin D3 Supplements 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Liaquat University Hospital

Jāmshoro, Sindh, 76090, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Complementary therapy

Dietary Supplement

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

Standard of care

Drug

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

Primary outcomes

  1. SARS-CoV-2 Negativity by RT-PCR

    Time frame: up to 14 days

    Number of patients testing negative for COVID-19

  2. COVID-19 symptoms improvement

    Time frame: up to 7 days

    Number of patients with improvement in COVID-19 acute symptoms

Secondary outcomes

  1. Improvement in the serum inflammatory marker level

    Time frame: up to 7 days

    Changes in the serum CRP level

  2. Improvement in the serum inflammatory marker level

    Time frame: up to 7 days

    Changes in the serum D-dimer level

  3. Improvement in the serum inflammatory marker level

    Time frame: up to 7 days

    Changes in the serum LDH level

  4. Improvement in the serum inflammatory marker level

    Time frame: up to 7 days

    Changes in the serum ferritin level

  5. Hospitalization rate

    Time frame: up to 14 days

    Number of patients required hospitalization

  6. Length of hospitalization

    Time frame: up to 14 days

    Number of hospital admission days

  7. Length of supplementary oxygen therapy

    Time frame: up to 14 days

    Patients requirement oxygen at during hospitalization

  8. ICU transfer

    Time frame: up to 14 days

    Numbers of patients progressing to ICU

  9. Mechanical ventilation

    Time frame: up to 14 days

    Numbers of patients requiring mechanical ventilation at hospital

  10. All cause mortality

    Time frame: up to 14 days

    Numbers of hospital mortality

  11. Safety and tolerability

    Time frame: up to 14 days

    Any adverse event due to the investigational treatment

Sponsors and collaborators

Lead sponsor

Liaquat University of Medical & Health Sciences

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Oct 27, 2020
Registry last updated
Mar 23, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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