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Arginine Replacement Therapy in COVID-19
Prospective Open-Label Pilot Study of Arginine Replacement Therapy in Children Hospitalized With COVID-19
Who can join
Ages 3 to 21 · All sexes
Full eligibility criteria
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
About the study
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.
What is being tested
- Arginine Hydrochloride (drug)
Sponsor: Emory University · Participants: 21 · Started: Jan 8, 2024
Contact the study team
- Claudia R. Morris, MD · Phone: 404 727-5500
- Dunia Hatabah, MD · Phone: 470-6626706
Official record on ClinicalTrials.gov — NCT05855330
Locations in the U.S.
| Georgia | Children's Healthcare of Atlanta (CHOA), Arthur M. Blank, Atlanta |
Conditions
From ClinicalTrials.gov, data retrieved Oct 2, 2026. Each study sets its own eligibility; the study team decides who can join.