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

NCT ID: NCT05371288

Last Updated: 2024-11-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

EARLY_PHASE1

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-30

Study Completion Date

2025-11-30

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.

Detailed Description

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Conditions

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COVID-19

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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No Multivitamin and Magnesium

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

Group Type EXPERIMENTAL

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

Intervention Type DRUG

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

Multivitamin and Magnesium

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

Group Type ACTIVE_COMPARATOR

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

Intervention Type DRUG

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

Interventions

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

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

Intervention Type DRUG

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hudson Valley Healing Arts Center

UNKNOWN

Sponsor Role collaborator

University of California, Irvine

OTHER

Sponsor Role lead

Responsible Party

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Alpesh N Amin

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of California Irvine Medical Center

Orange, California, United States

Site Status

Countries

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United States

Other Identifiers

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CCR-21-128

Identifier Type: -

Identifier Source: org_study_id

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