Arginine Replacement Therapy in COVID-19

• Status: Not yet recruiting
• Trial end date: 2025-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is 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 in Children's Healthcare of Atlanta, Egleston campus. 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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Emory University

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