Arginine Replacement Therapy in COVID-19

{ "Arginine Replacement Therapy for Children with COVID-19", "This study is looking at whether giving doses of Arginine Hydrochloride, a protein found naturally in the body, can improve how well cells produce energy (mitochondrial function) in children hospitalized with COVID-19. Researchers believe that severe COVID-19 can lead to a lack of arginine, which might contribute to serious complications. The study will involve 21 children, aged 3 to 21, who have COVID-19 and need hospital care. You would receive one of three different doses of Arginine Hydrochloride three times a day for up to five days, or until you are discharged from the hospital. The main goal is to see how mitochondrial function changes from the beginning of the study to day 5.", "design": "This is an interventional study with 21 participants. Participants will be randomly assigned to receive one of three doses of Arginine Hydrochloride.", "commitments": "You would receive Arginine Hydrochloride infusions three times a day for up to five days, or until hospital discharge. Mitochondrial function will be measured at the start of the study and on day 5.", "compensation": "Not stated in the trial record.", "follow_up": "Mitochondrial function will be measured at baseline and on day 5.", }

Study design
Not specified.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Not specified.

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NCT05855330

Arginine Replacement Therapy in COVID-19

Recruiting
PHASE2Ages 3–21InterventionalTreatment
Emory University
~21 participants
Updated 2026-04-15 on ClinicalTrials.gov
What's tested:Arginine Hydrochloride

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in mitochondrial function
Measured over Baseline and day 5
COVID-19
1 sites across 1 states
Georgia1
  • Claudia R. Morris, MD · PRINCIPAL_INVESTIGATOR · Emory University

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Eligibility criteria

Inclusion

Established diagnosis of COVID-19 requiring admission to the hospital for treatment of COVID-19 infection
Age 3 years - 21 years of age

Exclusion

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
  • Change in mitochondrial functionBaseline and day 5

    Complex-IV activity changes will be measured to estimate mitochondrial function before and after administration for L-arginine