NCT05855330 · Emory University
Arginine Replacement Therapy in COVID-19
(ART-COVID19)
What this study is about
This study aims to investigate if receiving doses of arginine (a protein in the body) will improve mitochondria function in children with COVID-19. The study will be performed at the Children's Healthcare of Atlanta, Arthur M. Blank Hospital. Patients will be randomly assigned to receive one of three doses of arginine three times a day for five days or at discharge whichever comes first.
View original scientific description
This study aims to investigate if receiving doses of arginine (a protein in the body) will improve mitochondria function in children with COVID-19. The study will be performed at the Children's Healthcare of Atlanta, Arthur M. Blank Hospital. Patients will be randomized to receive one of three doses of arginine three times a day for five days or at discharge whichever comes first.
Interventions
DRUG
Arginine Hydrochloride
Arginine will be infused based on the manufacturer's instructions (R-Gene 10, Pfizer), over 30 minutes. However, rates may be slowed to over 60 minutes for patients experiencing symptoms of flushing, nausea, vomiting, or headache at the research team's discretion. Pediatric doses will be drawn up by the pharmacy.
Primary outcome measures
Change in mitochondrial function
Time frame: Baseline and day 5
Complex-IV activity changes will be measured to estimate mitochondrial function before and after administration for L-arginine
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Established diagnosis of COVID-19 requiring admission to the hospital for treatment of COVID-19 infection
- Age 3 years - 21 years of age
Exclusion criteria
- Severe hepatic dysfunction: ALT\> 6 x Upper limit of normal
- Renal dysfunction: Creatinine \> 1.5 x upper limit of normal or on dialysis
- Acute Stroke
- Allergy to arginine
- Past history of severe cardiac disease or significant cardiac surgery \[minor procedures like ventricular septal defect (VSD) repair are not an exclusion\]
- History of significant pulmonary disease \[Cystic Fibrosis, sickle cell disease (SCD)\]
- History of organ transplant
- History of metabolic or mitochondrial disease (including Diabetes)
- History of severe neurocognitive delays (severe cerebral palsy, anoxic brain injury)
- History of ventriculoperitoneal (VP) shunt or hydrocephalus
- PI discretion that the patient is not an ideal candidate for the study
- History of HIV of immune compromise
Where
- Atlanta, Georgia
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 15, 2026 · Source of record for eligibility and locations