No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
3 – 21
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
21 (estimated)
Sponsor
Emory University · Other
Who this trial is looking for
This trial is looking for children aged 3 to 21 who have COVID-19 and need to be hospitalized. If eligible, participants will take doses of arginine three times a day for five days or until discharge.
Are You a Good Fit for This Trial?
Rules you outHIVSevere neurocognitive delaysMetabolic diseaseMitochondrial disease
You may be able to join if
I have been diagnosed with COVID-19 requiring hospital treatment
I am between 3 and 21 years old
You may not be able to join if
I have severe liver problems
I have severe kidney problems or need dialysis
I have had a stroke
I am pregnant
I am allergic to arginine
I have a history of serious heart disease or major heart surgery
I have significant lung disease like cystic fibrosis
I have a history of organ transplant
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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.
Trial Locations
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City
State
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Status
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…
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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