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

• Sponsor: University of California, Irvine (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05371288
• Collaborator: Hudson Valley Healing Arts Center (Other)
• Enrollment: 50
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 5
• Patients Per Site Per Month: 9.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
COVID-19	Dietary Supplement: NAC (N-acetyl cysteine) , Alpha lipoic acid (ALA), liposomal glutathione (GSH)	Early Phase 1

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 50 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: The Role of Glutathione Deficiency and MSIDS Variables in Long COVID-19
• Anticipated Study Start Date: Jun 1, 2022
• Anticipated Primary Completion Date: Sep 1, 2022
• Anticipated Study Completion Date: Nov 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm A 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); Nutritional supplements hypothesized to help reverse some of the COVID long-haul symptoms.
Active Comparator: Arm B 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); Nutritional supplements hypothesized to help reverse some of the COVID long-haul symptoms.

Outcome Measures

Primary Outcome Measures

1. 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.

2. 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.

3. 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.

4. 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]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of California Irvine Medical Center	Orange	California	United States	92868

Sponsors and Collaborators

• University of California, Irvine
• Hudson Valley Healing Arts Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Alpesh N Amin, Principal Investigator, University of California, Irvine
• ClinicalTrials.gov Identifier: NCT05371288
• Other Study ID Numbers: CCR-21-128
• First Posted: May 12, 2022
• Last Update Posted: May 12, 2022
• Last Verified: May 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: Yes
• Keywords provided by Alpesh N Amin, Principal Investigator, University of California, Irvine: Covid-19 Long-Haul
• Additional relevant MeSH terms: COVID-19; Thioctic Acid; Acetylcysteine; N-monoacetylcystine

Study Results

No Results Posted as of May 12, 2022