Antioxidant Supplements for Long COVID-19

Overseen By Jeein Kim

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: University of California, Irvine

Disqualifiers: Severe sulfa sensitivity, Alpha gal allergy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial is testing if a mix of supplements can help people with long-term COVID-19 symptoms. The supplements may reduce body damage and inflammation to improve these lingering symptoms.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is it safe to take antioxidant supplements like Alpha lipoic acid (ALA) and N-acetyl cysteine (NAC)?

Research shows that Alpha lipoic acid (ALA) is generally safe for humans, with no increased risk of side effects in various groups, including those with diabetes, heart issues, and even during pregnancy. N-acetyl cysteine (NAC) also shows antioxidant benefits and is safe, improving blood health in studies. ^{1 2 3 4 5}

How does the antioxidant treatment for Long COVID-19 differ from other treatments?

This treatment is unique because it uses a combination of antioxidants like Alpha lipoic acid (ALA), Liposomal glutathione (GSH), and NAC (N-acetyl cysteine) to potentially reduce oxidative stress and inflammation, which are believed to contribute to Long COVID symptoms. Unlike other treatments, this approach focuses on boosting the body's natural antioxidant defenses, which may help improve recovery from Long COVID. ^{6 7 8 9 10}

What evidence supports the effectiveness of antioxidant supplements like Alpha lipoic acid, Liposomal glutathione, and NAC for treating Long COVID-19?

Research suggests that oxidative stress and inflammation are key factors in Long COVID, and antioxidants may help reduce these issues. Studies have shown that antioxidants can improve symptoms in COVID-19 patients by reducing inflammation and oxidative stress, which are similar problems faced in Long COVID. ^{6 10 11 12 13}

Are You a Good Fit for This Trial?

This trial is for individuals who have tested positive for COVID-19 and are experiencing mild to severe long-haul symptoms. They must not have allergies or adverse reactions to NAC, ALA, or GSH, no meat product/gelatin allergies (alpha gal allergy), and no history of severe sulfa sensitivity.

Inclusion Criteria

I tested positive for COVID and have symptoms ranging from mild to severe.

Exclusion Criteria

You have had a bad reaction to NAC, alpha lipoic acid, or GSH in the past.

You are allergic to meat products or gelatin.

You have had a severe reaction to sulfa drugs in the past, such as anaphylaxis or Stevens Johnson Syndrome.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either a combination of NAC, Alamax CR, and liposomal GSH or the same supplements with a multivitamin and magnesium for 28 days

4 weeks

Daily administration

Follow-up

Participants are monitored for changes in symptoms and quality of life post-treatment

4 months

Evaluations at 2 weeks, 1, 2, 3, and 4 months post-therapy

What Are the Treatments Tested in This Trial?

Interventions

• Alpha lipoic acid (ALA)
• Liposomal glutathione (GSH)
• NAC (N-acetyl cysteine)

Trial Overview The study tests if glutathione combined with NAC and ALA can improve long COVID symptoms. Participants will be randomly assigned to receive these supplements with or without a multivitamin and magnesium, while their health status is monitored through questions and blood samples.

How Is the Trial Designed?

Group I: No Multivitamin and Magnesium Experimental Treatment 1 Intervention

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 II: Multivitamin and Magnesium Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

University of California, Irvine

Lead Sponsor

Trials

580

Recruited

4,943,000+

Hudson Valley Healing Arts Center

Collaborator

Trials

1

Published Research Related to This Trial

This systematic scoping review identified five studies exploring nutritional interventions for long COVID, highlighting the potential benefits of nutrients like B vitamins, vitamin C, vitamin D, and acetyl-l-carnitine, particularly in rehabilitation settings.

While initial reports on nutritional supplements showed positive outcomes, the studies were poorly designed, indicating a need for more rigorous clinical trials to establish effective dietary interventions for long COVID symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nutritional Support During Long COVID: A Systematic Scoping Review. Bradbury, J., Wilkinson, S., Schloss, J.[2023]

Citations

1. Netherlands pubmed.ncbi.nlm.nih.gov

Combining L-Arginine with vitamin C improves long-COVID symptoms: The LINCOLN Survey. [2023]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Oxidative Stress and Inflammatory Status in COVID-19 Outpatients: A Health Center-Based Analytical Cross-Sectional Study. [2022]

3. Switzerland pubmed.ncbi.nlm.nih.gov

The Efficacy of Antioxidant Oral Supplements on the Progression of COVID-19 in Non-Critically Ill Patients: A Randomized Controlled Trial. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Nutritional Support During Long COVID: A Systematic Scoping Review. [2023]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Oxidative Stress and Hyper-Inflammation as Major Drivers of Severe COVID-19 and Long COVID: Implications for the Benefit of High-Dose Intravenous Vitamin C. [2022]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Evaluation of the protective roles of alpha-lipoic acid supplementation on nanomaterial-induced toxicity: A meta-analysis of in vitro and in vivo studies. [2022]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Safety Evaluation of α-Lipoic Acid Supplementation: A Systematic Review and Meta-Analysis of Randomized Placebo-Controlled Clinical Studies. [2020]

8. Czech Republic pubmed.ncbi.nlm.nih.gov

The comparison of antioxidant and hematological properties of N-acetylcysteine and alpha-lipoic acid in physically active males. [2021]

9. New Zealand pubmed.ncbi.nlm.nih.gov

Tolerability in the elderly population of high-dose alpha lipoic acid: a potential antioxidant therapy for the eye. [2020]

10. United States pubmed.ncbi.nlm.nih.gov

Restoration of blood total glutathione status and lymphocyte function following alpha-lipoic acid supplementation in patients with HIV infection. [2019]

11. United States pubmed.ncbi.nlm.nih.gov

Alpha-lipoic acid may protect patients with diabetes against COVID-19 infection. [2021]

12. Switzerland pubmed.ncbi.nlm.nih.gov

Role of Nuclear Factor Erythroid 2 (Nrf2) in the Recovery of Long COVID-19 Using Natural Antioxidants: A Systematic Review. [2022]

13. Switzerland pubmed.ncbi.nlm.nih.gov

A Randomized, Single-Blind, Group Sequential, Active-Controlled Study to Evaluate the Clinical Efficacy and Safety of α-Lipoic Acid for Critically Ill Patients With Coronavirus Disease 2019 (COVID-19). [2023]