The Role of Glutathione Deficiency and MSIDS Variables in Long COVID-19

Study Overview
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Brief Summary
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The purpose of this research study is to assess if glutathione, along with NAC (N-acetyl cysteine) and Alpha lipoic acid (ALA), can help reverse some of the COVID long-haul symptoms.Subjects will be randomized in to one of two groups. Depending on the group they are randomized in to, subjects will be taking either a combination of NAC, Alamax CR, and liposomal GSH or the same three nutritional supplements with a multivitamin and magnesium. Regardless of the group, subjects will be asked questions to assess their COVID symptoms, physical and mental health status. They will also be asked to take blood samples.

Official Title
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The Role of Glutathione Deficiency and MSIDS Variables in Long COVID-19

Conditions
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COVID-19

Intervention / Treatment
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* Dietary Supplement: NAC (N-acetyl cysteine) , Alpha lipoic acid (ALA), liposomal glutathione (GSH)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: • Patients with positive COVID testing (AB, RT PCR) and mild-severe symptoms based on COVID symptom list Exclusion Criteria: • History of a severe sulfa sensitivity (i.e., anaphylaxis, Stevens Johnson Syndrome), allergy to meat products and/or gelatin (alpha gal allergy) and/or a history of an allergic or adverse reaction to NAC, alpha lipoic acid and/or GSH.

Ages Eligible for Study
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Minimum Age: 18 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm A<br>Subjects randomized into Group A will take the following amount for 28 days 4 capsules of NAC (600mg each) once in the morning and once in the evening 1 tablet (600mg) of Alamax CR once in the morning and once in the evening 8 capsules (250 mg each) of liposomal GSH in the morning and in the evening | Dietary Supplement: NAC (N-acetyl cysteine) , Alpha lipoic acid (ALA), liposomal glutathione (GSH)<br>* Nutritional supplements hypothesized to help reverse some of the COVID long-haul symptoms.<br>|
| Active Comparator: Arm B<br>Subjects randomized into Group B will be taking a multivitamin and magnesium for 14 days. Afterwards, they will take the following for 14 days. 4 capsules of NAC (600mg each) once in the morning and once in the evening 1 tablet (600mg) of Alamax CR once in the morning and once in the evening 8 capsules (250 mg each) of liposomal GSH in the morning and in the evening | Dietary Supplement: NAC (N-acetyl cysteine) , Alpha lipoic acid (ALA), liposomal glutathione (GSH)<br>* Nutritional supplements hypothesized to help reverse some of the COVID long-haul symptoms.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess Changes in Symptoms of Post-Acute Sequelae of COVID (PASC) | With the goal of reversing symptoms of Post-Acute Sequelae of COVID, this outcome measure aims to evaluate changes in symptoms before and after therapy, and determining which, if any symptoms are improved in each arm of the trial. | Symptoms will be evaluated at 2 weeks, 1-, 2-, 3- and 4 months post therapy | 
| Change in Quality of Life Using SF-36 Survey | The SF-36 survey is a multipurpose, short-form health survey with 36 questions to evaluate health-related Quality of Life . It yields an eight-scale profile of scores as well as physical and mental health summary measures. It is a generic measure, as opposed to one that targets a specific age, disease, or treatment group. | Will be evaluated at 2 weeks, 1-, 2-, 3- and 4 months post therapy | 
| COVID Severity of Symptoms Questionnaire | This will evaluate the changes in the severity of symptoms over time with treatment. | Day 15, 28, end of months 2, 3, 4 | 
| Change in Time to Clinical Recovery (TTCR) | Starting on day one of subjects' treatment, subjects will be asked if symptoms have improved or worsened, and the time it took for symptoms to change since their last treatment: (0 [no change], +1 [improved within 7 days], + 2 [improved within 14 days], +3 [improved within 28 days] + 4 [symptom resolved]; - 1 [worsened within 7 days], -2 [worsened within 14 days], - 3 [worsened within 28 days], - 4 [debilitating last 28 days] | Day 15 and 28 (month 1), and at the end of months 2, 3 and 4 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Covid-19 Long-Haul