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

October 24, 2023 updated by: Alpesh N Amin, University of California, Irvine
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 Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • California
      • Orange, California, United States, 92868
        • University of California Irvine Medical Center
        • Contact:
          • Alpesh Amin, MD, MBA
          • Phone Number: 714-456-3785
          • Email: anamin@uci.edu
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assess Changes in Symptoms of Post-Acute Sequelae of COVID (PASC)
Time Frame: 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.
Symptoms will be evaluated at 2 weeks, 1-, 2-, 3- and 4 months post therapy
Change in Quality of Life Using SF-36 Survey
Time Frame: 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.
Will be evaluated at 2 weeks, 1-, 2-, 3- and 4 months post therapy
COVID Severity of Symptoms Questionnaire
Time Frame: Day 15, 28, end of months 2, 3, 4
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)
Time Frame: 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]
Day 15 and 28 (month 1), and at the end of months 2, 3 and 4

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Irvine

Collaborators

Hudson Valley Healing Arts Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2024

Primary Completion (Estimated)

September 1, 2024

Study Completion (Estimated)

November 1, 2024

Study Registration Dates

First Submitted

April 8, 2022

First Submitted That Met QC Criteria

May 10, 2022

First Posted (Actual)

May 12, 2022

Study Record Updates

Last Update Posted (Actual)

October 25, 2023

Last Update Submitted That Met QC Criteria

October 24, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CCR-21-128

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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