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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05371288
Recruitment Status : Not yet recruiting
First Posted : May 12, 2022
Last Update Posted : May 12, 2022
Sponsor:
Collaborator:
Hudson Valley Healing Arts Center
Information provided by (Responsible Party):
Alpesh N Amin, University of California, Irvine

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

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Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Study Start Date : June 2022
Estimated Primary Completion Date : September 2022
Estimated Study Completion Date : November 2022

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  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]



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05371288


Contacts
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Contact: Jeein Kim 714-509-2487 jeeink2@hs.uci.edu

Locations
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United States, California
University of California Irvine Medical Center
Orange, California, United States, 92868
Contact: Alpesh Amin, MD, MBA    714-456-3785    anamin@uci.edu   
Contact: Beverly Alger, MD    949-824-2488    balger@uci.edu   
Sponsors and Collaborators
University of California, Irvine
Hudson Valley Healing Arts Center
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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    Key Record Dates
Last Update Posted: May 12, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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, University of California, Irvine:
Covid-19 Long-Haul
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Thioctic Acid
Acetylcysteine
N-monoacetylcystine
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Vitamin B Complex
Vitamins
Micronutrients
Antiviral Agents
Anti-Infective Agents
Expectorants
Respiratory System Agents
Free Radical Scavengers
Antidotes