Arginine Replacement Therapy in COVID-19
Prospective Open-Label Pilot Study of Arginine Replacement Therapy in Children Hospitalized With COVID-19
Emory University
21 participants
Jan 8, 2024
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria2
- Established diagnosis of COVID-19 requiring admission to the hospital for treatment of COVID-19 infection
- Age 3 years - 21 years of age
Exclusion Criteria13
- 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
- Pregnancy
- 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
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Interventions
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.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05855330