Arginine Replacement Therapy in COVID-19 (NCT05855330)
Prospective Open-Label Pilot Study of Arginine Replacement Therapy in Children Hospitalized With COVID-19
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (2 items) and avoid the listed exclusions (14 items).
Location: Children's Healthcare of Atlanta (CHOA), Arthur M. Blank — Atlanta, Georgia
Age range: 3 Years to 21 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- 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
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (1 Sites)
- Children's Healthcare of Atlanta (CHOA), Arthur M. Blank — Atlanta, Georgia
📞 Contact the Study Coordinator
Phone: (404) 727-5500
Email: claudia.r.morris@emory.edu
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in COVID-19
- Impact of Immunosuppression Adjustment on COVID-19 Vaccination Response in Kidney Transplant Recipients — Sacramento, California
- COVID-19 and Cancer Consortium Registry — Nashville, Tennessee
- Dysbiosis & Long COVID — Chicago, Illinois
- COVID-19, Chronic Adaptation and Response to Exercise (COVID-CARE) — Bethesda, Maryland
- COVID-19 Coagulopathy Extension Study — Iowa City, Iowa
- Identification and Characterization of SARS-CoV-2 Specific CD8 T Cells in Humans — Baltimore, Maryland
Explore by condition: All COVID-19 clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.