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

NCT05371288 | Withdrawn Early Phase 1 FDA Drug

• 1 other identifier: CCR-21-128
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19

Keywords

Covid-19 Long-Haul

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (2)

No Multivitamin and Magnesium

EXPERIMENTAL

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

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

Multivitamin and Magnesium

ACTIVE COMPARATOR

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

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

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.

Multivitamin and Magnesium; No Multivitamin and Magnesium

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with positive COVID testing (AB, RT PCR) and mild-severe symptoms based on COVID symptom list

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, Irvine: lead
• Hudson Valley Healing Arts Center: collaborator

Study Sites (1)

University of California Irvine Medical Center

Orange, California, 92868, United States

Location

MeSH Terms

Conditions

COVID-19; Post-Acute COVID-19 Syndrome

Interventions

Acetylcysteine; Thioctic Acid; Glutathione

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cysteine; Amino Acids, Sulfur; Sulfur Compounds; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins; Carboxylic Acids; Thiophenes; Coenzymes; Enzymes and Coenzymes; Fatty Acids; Lipids; Oligopeptides; Peptides

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 8, 2022
• First Posted: May 12, 2022
• Study Start: June 1, 2025
• Primary Completion: September 1, 2025
• Study Completion: November 1, 2025
• Last Updated: November 5, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)