NCT05130671

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable covid19

Timeline
Completed

Started Oct 2021

Shorter than P25 for not_applicable covid19

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 25, 2021

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

November 21, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 23, 2021

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

January 28, 2022

Status Verified

January 1, 2022

Enrollment Period

2 months

First QC Date

November 21, 2021

Last Update Submit

January 13, 2022

Conditions

COVID-19

Outcome Measures

Primary Outcomes (2)

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

    Testing of naso-pharyngeal swab for COVID-19

    Day 7

  • COVID-19 symptoms improvement

    Improvement of the typical symptoms associated with COVID-19 infection

    Day 7

Secondary Outcomes (5)

  • Improvement in CRP level

    Day 7

  • Improvement in D-dimers level

    Day 7

  • Improvement in LDH levels

    Day 7

  • Improvement in ferritin levels

    Day 7

  • Improvement in full blood count (CBC)

    Day 7

Study Arms (2)

Standard of care

ACTIVE COMPARATOR

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

Drug: Standard of care

Investigational treatment

EXPERIMENTAL

This arm will receive combination of nutritional supplements quercetin and curcumin as add-on to the standard of care.

Drug: Standard of careDietary Supplement: Investigational treatment

Interventions

Standard of careDRUG

Standard of care treatment as per the hospital guidelines

Investigational treatmentStandard of care
Investigational treatmentDIETARY_SUPPLEMENT

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

Investigational treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (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
  • 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

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

King Edward Medical University Teaching Hospital

Lahore, Punjab Province, 54000, Pakistan

Location

Related Publications (1)

  • Khan A, Iqtadar S, Mumtaz SU, Heinrich M, Pascual-Figal DA, Livingstone S, Abaidullah S. Oral Co-Supplementation of Curcumin, Quercetin, and Vitamin D3 as an Adjuvant Therapy for Mild to Moderate Symptoms of COVID-19-Results From a Pilot Open-Label, Randomized Controlled Trial. Front Pharmacol. 2022 Jun 7;13:898062. doi: 10.3389/fphar.2022.898062. eCollection 2022.

    PMID: 35747751DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

Standard of CareTherapies, Investigational

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and EvaluationTherapeutics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Medicine

Study Record Dates

First Submitted

November 21, 2021

First Posted

November 23, 2021

Study Start

October 25, 2021

Primary Completion

December 31, 2021

Study Completion

December 31, 2021

Last Updated

January 28, 2022

Record last verified: 2022-01

Locations

PA(1)