What this study is
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.
What's being tested
- Arginine Hydrochloride
Intervention · DRUG
Arginine will be infused based on the manufacturer's instructions (R-Gene 10, Pfizer), over 30 minutes. However, rates may be slowed to over 60 minutes for patients experiencing symptoms of flushing, nausea, vomiting, or headache at the research team's discretion. Pediatric doses will be drawn up by the pharmacy.
Study details
- Official title
- Prospective Open-Label Pilot Study of Arginine Replacement Therapy in Children Hospitalized With COVID-19
- Sponsor
- Emory University
- Conditions
- COVID-19
- Enrolling
- 21 people
- Starts
- 2024-01-08
- Est. completion
- 2027-06
- Design
- Open-label, randomized, parallel groups, Phase 2
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 3 Years – 21 YearsSex ALLHealthy volunteers Not acceptedYou may qualify if
- Established diagnosis of COVID-19 requiring admission to the hospital for treatment of COVID-19 infection
- Age 3 years - 21 years of age
You can't join if
- 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openChildren's Healthcare of Atlanta (CHOA), Arthur M. Blank
Atlanta, Georgia, United States
- Claudia R Morris, MD · Contact404 727-5500claudia.morris@choa.org
- Caludia R Morris, MD · Principal investigator
Recruiting
Study team
Sponsor
Emory University
Study ID STUDY00005572
Principal investigator
Claudia R. Morris, MD
Emory University
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.