Clinical trial NCT06974058: Study to Investigate the Health Benefits of a Quercetin/Curcumin-Based Supplement for Mild to Moderate Long COVID-19 Symptoms
Official title: Evaluation of a Quercetin/Curcumin-Based Supplement for Mild to Moderate Long COVID-19 Symptoms: A Pragmatic, Interventional Clinical Study.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Long COVID
Lead sponsor: Liaquat University of Medical & Health Sciences
Sponsor class: OTHER
First posted: 2025-05-15
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This is a pragmatic, open-label clinical study evaluating the benefits of a combined quercetin/curcumin supplement (Nasafytol®) in adults experiencing mild to moderate Long COVID-19 symptoms.
Primary purpose: TREATMENT

Brief summary: This pragmatic clinical study aims to evaluate the efficacy and tolerance of a combined quercetin/curcumin supplement in adults experiencing mild to moderate symptoms of Long COVID-19. Participants will receive the combined quercetin/curcumin supplement for 2 months. The primary outcome is the improvement in overall symptom burden, while secondary outcomes include changes in quality of life, the need for NSAIDs, and inflammatory markers. The study seeks to provide real-world evidence of the potential benefits of this combined supplement in managing Long COVID-19 symptoms.

Detailed description: Long COVID-19, characterized by persistent symptoms lasting weeks or months after the acute phase of SARS-CoV-2 infection, presents a significant challenge for healthcare systems and affected individuals. Common symptoms include fatigue, brain fog, muscle pain, joint pain, sleep disturbances, and generalized weakness. Despite extensive research, there are limited effective therapeutic options for managing Long COVID-19 symptoms.

Quercetin and curcumin, two natural compounds with well-documented anti-inflammatory, antioxidant, and immunomodulatory properties, have gained attention for their potential benefits in various inflammatory and infectious conditions. Quercetin, a flavonoid found in various fruits and vegetables, has been shown to inhibit pro-inflammatory cytokines, reduce oxidative stress, and modulate immune responses. Curcumin, a polyphenol derived from turmeric (Curcuma longa), is known for its strong anti-inflammatory and antioxidant properties and has demonstrated immune-modulating effects in clinical studies.

Nasafytol® is a standardized combination supplement containing bioactive quercetin (65 mg) and curcumin (42 mg) from Curcuma longa, specifically formulated to enhance bioavailability and provide synergistic benefits. Both quercetin and curcumin in Nasafytol® are optimized for absorption and efficacy, making it a promising intervention for managing inflammatory and immune-related conditions.

The combination of quercetin and curcumin in Nasafytol® is hypothesized to provide synergistic benefits in managing Long COVID-19 symptoms. This pragmatic clinical study aims to evaluate the efficacy of Nasafytol® in reducing symptom burden and improving quality of life in adults experiencing mild to moderate Long COVID-19 symptoms. Participants will receive the combined supplement for two months, with primary outcomes focused on symptom improvement and secondary outcomes assessing changes in quality of life, the need for NSAIDs, and inflammatory markers.

The study is designed as a real-world pragmatic trial to provide evidence of the potential health benefits of Nasafytol® for Long COVID-19, addressing a critical gap in current management strategies.

Eligibility criteria: Inclusion Criteria:

* Age: 18 to 75 years.
* History of confirmed COVID-19 infection at least 6 months prior to the enrollment.
* Persistent mild to moderate COVID-19 symptoms for at least 3 months post-acute infection.
* Diagnosis of Long COVID-19 based on WHO criteria.
* Symptom burden score of ≥25 at baseline (V0) on the COVID-19 Yorkshire Rehabilitation Scale (C19-YRS).
* At least one symptom scoring between 1-7 on the C19-YRS.
* Stable medical condition: No recent hospitalization (past 3 months) due to acute illness.
* Willing and able to adhere to the study protocol, including follow-up visits, symptom reporting, and compliance with supplementation

Exclusion Criteria:

* Hypersensitivity or allergy to quercetin, curcumin, or any component of the supplement (Nasafytol®).
* Severe, uncontrolled chronic illness (e.g., severe heart failure, chronic kidney disease requiring dialysis, severe liver disease).
* Regular use of quercetin or curcumin supplements within the last 3 months.
* Use of anticoagulants (e.g., warfarin, heparin, DOACs) due to potential anticoagulant effects of quercetin/curcumin.
* Acute illness at the time of screening.
* Pregnancy or breastfeeding.
* Use of immunosuppressive medications or corticosteroids within the past month.
* Significant psychiatric disorder that may interfere with study compliance.

Primary outcomes:
measure: Change in Overall Symptom Burden
timeFrame: Baseline and 8 weeks.
Secondary outcomes:
measure: Change in Functional Status and Quality of Life (SF-36 Scores)
timeFrame: Baseline and Week 8.
measure: Change in the Need for Prescribed Medications or NSAIDs (Non-Steroidal Anti-Inflammatory Drugs)
timeFrame: Baseline and Week 8.
measure: Change in the serum Inflammatory Biomarkers levels
timeFrame: Baseline and Week 8.
Other outcomes:
Locations:
city: Jamshoro
country: Pakistan
facility: Liaquat University of Medical & Health Sciences (LUMHS)
state: Sindh
Study officials:
References:
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citation: 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.
citation: 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.