COVID-19Early Phase 1NCT05371288
The Role of Glutathione Deficiency and MSIDS Variables in Long COVID-19
A Early Phase 1 study testing NAC (N-acetyl cysteine), Alpha lipoic acid (ALA), liposomal glutathione (GSH) in people with COVID-19, run by University of California, Irvine at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19
- What is being tested?
- NAC (N-acetyl cysteine), Alpha lipoic acid (ALA), liposomal glutathione (GSH)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2025to Nov 2025
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with positive COVID testing (AB, RT PCR) and mild-severe symptoms based on COVID symptom list
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California Irvine Medical Center
Orange, California, 92868
About this study
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.
- Conditions
- COVID-19
- Being tested
- NAC (N-acetyl cysteine), Alpha lipoic acid (ALA), liposomal glutathione (GSH)
- Keywords
- Covid-19 Long-Haul
- Medical subject headings
- COVID-19, Post-Acute COVID-19 Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NAC (N-acetyl cysteine), Alpha lipoic acid (ALA), liposomal glutathione (GSH)Drug
Nutritional supplements hypothesized to help reverse some of the COVID long-haul symptoms.
| Study group | Role | What they receive |
|---|---|---|
| No Multivitamin and Magnesium | Experimental | 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 Receives: Drug: NAC (N-acetyl cysteine), Alpha lipoic acid (ALA), liposomal glutathione (GSH) |
| Multivitamin and Magnesium | Active comparator | 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 Receives: Drug: NAC (N-acetyl cysteine), Alpha lipoic acid (ALA), liposomal glutathione (GSH) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Symptoms will be evaluated at 2 weeks, 1-, 2-, 3- and 4 months post therapy
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.
Measured: Will be evaluated at 2 weeks, 1-, 2-, 3- and 4 months post therapy
COVID Severity of Symptoms Questionnaire
This will evaluate the changes in the severity of symptoms over time with treatment.
Measured: Day 15, 28, end of months 2, 3, 4
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]
Measured: Day 15 and 28 (month 1), and at the end of months 2, 3 and 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2022
- Study startJun 2025 (estimated)
- Primary completionSep 2025 (estimated)
- Study completionNov 2025 (estimated)
Why it stopped: No longer studying long COVID
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by University of California, IrvineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Irvine
- Sponsor type
- University, hospital or other
- Collaborators
- Hudson Valley Healing Arts Center
- Responsible party
- Principal investigator, Alpesh N Amin, University of California, Irvine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05371288
- Sponsor's protocol ID
- CCR-21-128
- Status last verified
- Oct 2024
- First submitted
- 8 Apr 2022
- Last updated
- 5 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Glutathione Deficiency and MSIDS Variables in Long COVID-19
- ClinicalTrials.gov ID
- NCT05371288
- Acronym / sponsor ID
- CCR-21-128
- Conditions
- COVID-19
- Keywords
- Covid-19 Long-Haul
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No longer studying long COVID
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of California, IrvineUniversity, hospital or other
- Collaborators
- Hudson Valley Healing Arts Center
- Study start
- Jun 2025 (estimated)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Nov 2025 (estimated)
- First posted
- 12 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No Multivitamin and Magnesium | Experimental | Drug: NAC (N-acetyl cysteine), Alpha lipoic acid (ALA), liposomal glutathione (GSH)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 |
| Multivitamin and Magnesium | Active comparator | Drug: NAC (N-acetyl cysteine), Alpha lipoic acid (ALA), liposomal glutathione (GSH)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 may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with positive COVID testing (AB, RT PCR) and mild-severe symptoms based on COVID symptom list
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NAC (N-acetyl cysteine), Alpha lipoic acid (ALA), liposomal glutathione (GSH)Nutritional supplements hypothesized to help reverse some of the COVID long-haul symptoms. | Drug | Multivitamin and Magnesium, No Multivitamin and Magnesium |
Primary outcome
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.
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.
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.
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]
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing NAC (N-acetyl cysteine), Alpha lipoic acid (ALA), liposomal glutathione (GSH) in people with COVID-19, run by University of California, Irvine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 5 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2024.