NCT05855330 Arginine Replacement Therapy in COVID-19
| NCT ID | NCT05855330 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Emory University |
| Condition | COVID-19 |
| Study Type | INTERVENTIONAL |
| Enrollment | 21 participants |
| Start Date | 2024-01-08 |
| Primary Completion | 2028-06 |
Trial Parameters
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Brief 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 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
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