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

COVID-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05371288
• Other study ID #: CCR-21-128
• Status: Not yet recruiting
• Phase: Early Phase 1
• Start date: June 2024
• Est. completion date: November 2024

Study information

• Verified date: October 2023
• Source: University of California, Irvine
• Contact: Jeein Kim
• Phone: 714-509-2487
• Email: jeeink2[@]hs.uci.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: November 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19

Intervention

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.

Locations

Country	Name	City	State
United States	University of California Irvine Medical Center	Orange	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, Irvine	Hudson Valley Healing Arts Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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