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

Primary Purpose

COVID-19

Status
Not yet recruiting
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
NAC (N-acetyl cysteine) , Alpha lipoic acid (ALA), liposomal glutathione (GSH)
Sponsored by
University of California, Irvine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COVID-19 focused on measuring Covid-19 Long-Haul

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of California Irvine Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm A

Arm B

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.
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.
COVID Severity of Symptoms Questionnaire
This will evaluate the changes in the severity of symptoms over time with treatment.
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]

Secondary Outcome Measures

Full Information

First Posted
April 8, 2022
Last Updated
October 24, 2023
Sponsor
University of California, Irvine
Collaborators
Hudson Valley Healing Arts Center
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1. Study Identification

Unique Protocol Identification Number
NCT05371288
Brief Title
The Role of Glutathione Deficiency and MSIDS Variables in Long COVID-19
Official Title
The Role of Glutathione Deficiency and MSIDS Variables in Long COVID-19
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 2024 (Anticipated)
Primary Completion Date
September 2024 (Anticipated)
Study Completion Date
November 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Irvine
Collaborators
Hudson Valley Healing Arts Center

4. Oversight

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

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19
Keywords
Covid-19 Long-Haul

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm A
Arm Type
Experimental
Arm Description
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
Arm Title
Arm B
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Dietary Supplement
Intervention Name(s)
NAC (N-acetyl cysteine) , Alpha lipoic acid (ALA), liposomal glutathione (GSH)
Intervention Description
Nutritional supplements hypothesized to help reverse some of the COVID long-haul symptoms.
Primary Outcome Measure Information:
Title
Assess Changes in Symptoms of Post-Acute Sequelae of COVID (PASC)
Description
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
Title
Change in Quality of Life Using SF-36 Survey
Description
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
Title
COVID Severity of Symptoms Questionnaire
Description
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
Title
Change in Time to Clinical Recovery (TTCR)
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jeein Kim
Phone
714-509-2487
Email
jeeink2@hs.uci.edu
Facility Information:
Facility Name
University of California Irvine Medical Center
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alpesh Amin, MD, MBA
Phone
714-456-3785
Email
anamin@uci.edu
First Name & Middle Initial & Last Name & Degree
Beverly Alger, MD
Phone
949-824-2488
Email
balger@uci.edu

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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