The Effect of Micellized Food Supplements on Health-related Quality of Life in Patients With Post-acute COVID-19 Syndrome.

Study Overview
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Brief Summary
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Food supplements like curcumin and boswellia serrata have been used traditionally for anti-inflammatory purposes. A well-known problem of these substances in their natural form is the low bioavailability. Micellization of these substances has been shown to increase the bioavailability significantly and thereby the clinical efficacy. The clinical value of these micellized substances has been presented in numerous clinical studies and in particular in patients with acute COVID-19. This study aims to examine the effect of a mixture of micellized curcumin, boswellia serrata and ascorbic acid on patients with long COVID.

Detailed Description
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The participants will be asked to take the micellized supplements daily, at home for 6 weeks. During this 6 weeks several questionnaires will be taken to asses general health-related quality of life. Follow-up measurements will be done at 14 weeks.

Official Title
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The Effect of a Mixture of Micellized Curcumin/Boswellia Serrata/Ascorbic Acid on Health-related Quality of Life in Patients With Post-acute COVID-19 Syndrome.

Conditions
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Post-acute COVID-19 Syndrome

Intervention / Treatment
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* Dietary Supplement: Curcumin/Boswellia Serrata/Ascorbic acid mixture


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with confirmed SARS-CoV-2 infection at least 28 days prior to study participation Patients who are experiencing symptoms of PACS (with a PCFS of 1 or higher) 18 years or older and younger than 85 Good understanding of written German Exclusion Criteria: Currently under pharmacological treatment for PACS Any planned medical surgery or intervention where medication intake is necessary in the coming 14 weeks Allergy to curcumin or Boswellia Active malignancy Medical history of Human Immunodeficiency Virus (HIV) infection, or any serious immunocompromised state. Pregnancy (or planned pregnancy in the coming 14 weeks) ( - Patients who are taking anticoagulants or have diabetes type I or II are only allowed to participate if their general practitioner is informed)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Single-arm intervention
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Curcumin/Boswellia Serrata/Ascorbic acid mixture<br>The daily intake of 2x10 drops of a mixture of micellized curcumin(2%), boswellia serrata (1,5%) and ascorbic acid (6%). | Dietary Supplement: Curcumin/Boswellia Serrata/Ascorbic acid mixture<br>* The daily intake of 2x10 drops of a mixture of micellized curcumin (2%), boswellia serrata (1.5%) and ascorbic acid (6%).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in health-related quality of life | Health-related quality of life is measured with the 'Short-Form 12' (SF-12) from 0 to 100, where higher scores on the SF-12 represent better health-related quality of life. | Week 1, 2, 3, 4, 5, 6, 10 and 14. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in patient selected functional limitations in daily life, measured with the 'Patient specific functional scale (PSFS). | Patient specific limitations in daily life are measured with the 'Patient Specific Functional Scale' (PSFS). The scale is a visual analogue scale ranging from 0 to 100, with 0 meaning no limitations in the patient selected functional activity and 100 means it is impossible to perform this activity. | Week 1, 2, 3, 4, 5, 6, 10 and 14. | 
| Change in general health status | Change in general health status is measured with a dichotomous yes or no question. | Day 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 , 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21 | 
| Change in general health | Percentage of change of general health is asked for, where 0 represents no change and 100% means complete change, | Day 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 , 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21 | 
| Change in Post COVID functional status measured with the 'Post COVID Functional Status' (PCFS). | Self-Test for ordinal scaling of degree of post-COVID symptoms with 0 representing no symptoms and 4 several functional limitations. | Week 1, 2, 3, 4, 5, 6, 10 and 14. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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micelles, dietary supplements