COVID-19
Conditions
Keywords
Covid-19 Long-Haul
Brief summary
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.
Interventions
DRUGNAC (N-acetyl cysteine), Alpha lipoic acid (ALA), liposomal glutathione (GSH)
Nutritional supplements hypothesized to help reverse some of the COVID long-haul symptoms.
Sponsors
Hudson Valley Healing Arts Center
University of California, Irvine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assess Changes in Symptoms of Post-Acute Sequelae of COVID (PASC) | Symptoms will be evaluated at 2 weeks, 1-, 2-, 3- and 4 months post therapy | 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. |
| Change in Quality of Life Using SF-36 Survey | Will be evaluated at 2 weeks, 1-, 2-, 3- and 4 months post therapy | 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. |
| COVID Severity of Symptoms Questionnaire | Day 15, 28, end of months 2, 3, 4 | This will evaluate the changes in the severity of symptoms over time with treatment. |
| Change in Time to Clinical Recovery (TTCR) | Day 15 and 28 (month 1), and at the end of months 2, 3 and 4 | 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 \[debilitating last 28 days\] |
Countries
United States
Outcome results
None listed