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NCT04703036 · ClinicalTrials.gov registry record · Early Phase 1
Glutathione, Oxidative Stress and Mitochondrial Function in COVID-19
A Early Phase 1 study, sponsored by Baylor College of Medicine.
- Terminated
- Registry status
- Early Phase 1
- Development phase
- 4
- Enrollment target
NCT04703036 is a Early Phase 1 study that was terminated before completion, run by Baylor College of Medicine. The registered enrollment target is 4 participants.
The verdict
NCT04703036, a Early Phase 1 study, was terminated before completion, sponsored by Baylor College of Medicine.
- TERMINATED
- Registry status
- Early Phase 1
- Development phase
- 4 participants
- Enrollment target
Study Summary
COVID-19 is associated with increased mortality, and has been linked to a 'cytokine inflammatory storm'. Populations at higher risk of COVID complications and mortality include the elderly, diabetic patients and immunocompromised patients (such as HIV), and the investigators have studied these 3 populations over the past 20 years and have found that they all have deficiency of the endogenous antioxidant protein glutathione (GSH), elevated oxidative stress, inflammation, impaired mitochondrial function, immune dysfunction, and endothelial dysfunction. It is known and established that GSH adequacy is necessary for neutralizing harmful oxidative stress, and that elevated oxidative stress appears to promote mitochondrial dysfunction. The combination of oxidative stress and mitochondrial dysfunction have also been linked to inflammation, immune dysfunction, and endothelial dysfunction. In prior studies in aging, the investigators have also identified that supplementing glutathione precursor amino-acids glycine and cysteine (provided as N-acetylcysteine) improves GSH deficiency and mitochondrial function, and lowers oxidative stress, inflammation, and endothelial dysfunction. The investigators have coined the term GlyNAC to refer to the combination of glycine and N-acetylcysteine. This study will evaluate the prevalence and extent of these defects in patients with COVID-19 admitted to the hospital, and the response to supplementing GlyNAC or placebo for 2-weeks. Because patients with COVID-19 are also being reported to have fatigue and cognitive impairment, the investigators will also measure fatigue and cognition at admission, 1-week and 2-weeks after beginning supplementation. The supplementation is stopped after completing 2-weeks, and these outcomes will be measured again after 4-weeks and 8-weeks after stopping supplementation.
Interventions
- DIETARY_SUPPLEMENT Glycine
- DIETARY_SUPPLEMENT N-acetylcysteine
- DIETARY_SUPPLEMENT Alanine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4 participants |
| Start Date | 2021-01-11 |
| Est. Completion | 2023-03-31 |
| Phase | Early Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04703036
The ClinicalTrials.gov registry entry for NCT04703036 describes a study currently listed as terminated, categorized as Early Phase 1. The registered enrollment target is 4 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Baylor College of Medicine, which has 616 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Glycine is the first listed.
NCT04703036 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04703036 about?
NCT04703036 is a clinical study titled "Glutathione, Oxidative Stress and Mitochondrial Function in COVID-19". COVID-19 is associated with increased mortality, and has been linked to a 'cytokine inflammatory storm'. Populations at higher risk of COVID complications and mortality include the elderly, diabetic patients and immunocompromised patients (such as HIV), and the investigators have studied these 3 pop...
What is the current status of trial NCT04703036?
This trial is currently terminated. It is a Early Phase 1 study. The enrollment target is 4 participants. The study started on 2021-01-11. Estimated completion is 2023-03-31.
What interventions are being tested in trial NCT04703036?
The interventions under investigation include: Glycine (DIETARY_SUPPLEMENT), N-acetylcysteine (DIETARY_SUPPLEMENT), Alanine (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT04703036?
This trial is sponsored by Baylor College of Medicine, which has 616 total clinical trials registered on ClinicalTrials.gov.
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