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RECRUITINGPhase 2INTERVENTIONAL

Arginine Replacement Therapy in COVID-19

Prospective Open-Label Pilot Study of Arginine Replacement Therapy in Children Hospitalized With COVID-19

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - Established diagnosis of COVID-19 requiring admission to the hospital for treatment of COVID-19 infection - Age 3 years - 21 years of age Who Should NOT Join This Trial: - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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 * 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

Treatments Being Tested

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.

Locations (1)

Children's Healthcare of Atlanta (CHOA), Arthur M. Blank
Atlanta, Georgia, United States