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Completed

NCT Number: NCT05130671

Nutritional Supplementation of Flavonoids Quercetin and Curcumin for Early Mild Symptoms of COVID-19

The purpose of this study is to investigate the therapeutic benefits of flavonoids nutritional supplements quercetin and curcumin for early mild symptoms of COVID-19.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

King Edward Medical University Teaching Hospital

Lahore, Punjab Province, 54000, Pakistan

About this study

Flavonoids nutritional supplements quercetin and curcumin have demonstrated strong antioxidant, broad-spectrum anti-viral and anti-inflammatory properties including against the respiratory tract infections. They are widely used to boost the immunity against infections and keeping healthy life-style. Results from recent published studies have shown positive results for quercetin and curcumin in patients with COVID-19.

In the present study the investigators aim to study the combined beneficial effects of quercetin and curcumin in addition to standard of care for managing early mild symptoms of COVID-19 in community-based patients.

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
  • 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 withshaking, 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 suppering patients
  • Patients with moderate or severe thrombocytopenia (platelet count <100 ×10⁹/L);
  • Pregnant patients

Treatment and study plan

Standard of care

Drug

Standard of care treatment as per the hospital guidelines

Investigational treatment

Dietary Supplement

Combination of quercetin and curcumin as add-on to the standard of care

Primary outcomes

  1. Testing negative for SARS-CoV-2 by Reverse Transcription Polymerase Chain Reaction (RT-PCR)

    Time frame: Day 7

    Testing of naso-pharyngeal swab for COVID-19

  2. COVID-19 symptoms improvement

    Time frame: Day 7

    Improvement of the typical symptoms associated with COVID-19 infection

Secondary outcomes

  1. Improvement in CRP level

    Time frame: Day 7

    Improvement in the CRP levels

  2. Improvement in D-dimers level

    Time frame: Day 7

    Improvement in D-dimers level

  3. Improvement in LDH levels

    Time frame: Day 7

    Improvement in LDH levels

  4. Improvement in ferritin levels

    Time frame: Day 7

    Improvement in Ferritin levels

  5. Improvement in full blood count (CBC)

    Time frame: Day 7

    Improvement in CBC levels

Sponsors and collaborators

Lead sponsor

King Edward Medical University

Other

Registry information

Official study title

Treatment Benefits of Flavonoids Quercetin and Curcumin Supplements for Mild Symptoms of COVID-19

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Nov 23, 2021
Registry last updated
Jan 28, 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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