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

Early Phase 1WithdrawnNCT05371288

University of California, Irvine

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Conditions

COVID-19

Interventions

NAC (N-acetyl cysteine), Alpha lipoic acid (ALA), liposomal glutathione (GSH)DRUG

Nutritional supplements hypothesized to help reverse some of the COVID long-haul symptoms.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

University of California Irvine Medical Center

Orange, California, United States

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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 \[debilitating last 28 days\]

Time frame: Day 15 and 28 (month 1), and at the end of months 2, 3 and 4

Data from ClinicalTrials.gov

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