Arginine Replacement Therapy in COVID-19
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.
Conditions:
🦠 COVID-19
🗓️ Study Start (Actual) 8 January 2024
🗓️ Primary Completion (Estimated) June 2025
✅ Study Completion (Estimated) June 2025
👥 Enrollment (Estimated) 21
🔬 Study Type INTERVENTIONAL
📊 Phase PHASE2
Locations:
📍 Atlanta, Georgia, United States

📋 Eligibility Criteria

Description

    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
Ages Eligible for Study: 3 Years to 21 Years (CHILD, ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 9 May 2023
  • First Submitted that Met QC Criteria 9 May 2023
  • First Posted 11 May 2023

Study Record Updates

  • Last Update Submitted that Met QC Criteria 26 February 2024
  • Last Update Posted 28 February 2024
  • Last Verified February 2024