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Purpose

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.

Condition

Eligibility

Eligible Ages
Between 55 Years and 85 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Age 55-85y; - Diagnosis of COVID-19; - Hospitalized patients.

Exclusion Criteria

  • Active heart disease or active cancer at time of recruitment; - Patients in Intensive Care Unit at the time of recruitment; - Patents with alanine transaminase and aspartate transaminase greater than 5 times the upper limit of normal at any time; - Patients requiring >4L per minute of oxygen support at the time of recruitment.

Study Design

Phase
Early Phase 1
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Randomized controlled trial, placebo-controlled, double-blind design
Primary Purpose
Other
Masking
Double (Participant, Investigator)
Masking Description
Participants and the investigative team are masked. Only the biostatistician will be unmasked to the identity of the active and placebo groups.

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Active arm 		The active supplements are glycine and N-acetylcysteine
  • Dietary Supplement: Glycine
    Glycine is an amino-acid (protein)
  • Dietary Supplement: N-acetylcysteine
    This is a donor of the amino-acid cysteine (protein)
Placebo Comparator
Placebo arm 		The placebo arm is alanine
  • Dietary Supplement: Alanine
    Alanine is an amino-acid (protein)

Recruiting Locations

More Details

NCT ID
NCT04703036
Status
Terminated
Sponsor
Baylor College of Medicine

Detailed Description

This study will investigate associated defects in the following two populations of patients with COVID-19: Hospitalized patients admitted for COVID-19 will sign an informed consent form, and be randomized to receive either active (Glycine plus N-acetylcysteine) or a placebo (alanine) supplementation for 2-weeks. On day-0, the participants will have a single blood draw to measure measure oxidative stress, Glutathione levels, inflammatory cytokines, endothelial dysfunction, mitochondrial dysfunction, immune dysfunction, and complete questionnaires to assess fatigue, activity and cognition. Additional clinical and lab information will be obtained from the hospital electronic medical records. These measurements will be repeated 1-week and 2-weeks after starting supplementation, and at 4-weeks and 8-weeks after stopping supplementation.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.