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Arginine Replacement Therapy in COVID-19

RecruitingPhase 2

Sponsor: Emory University

Conditions: COVID-19

Interventions: Arginine Hydrochloride

Countries: United States

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 overview

Sex: ALL

Age: 3 Years to 21 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

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

Locations (1)

Atlanta, Georgia, United States