Recruiting
Phase 2

Arginine Replacement Therapy

Sponsor:

Emory University

Code:

NCT05855330

Conditions

COVID-19

Eligibility Criteria

Sex: All

Age: 3 - 21

Healthy Volunteers: Not accepted

Interventions

Arginine Hydrochloride

Study Details

Brief summary:

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.

Conditions

COVID-19

Study ID

NCT05855330

Start date

Jan 8, 2024

Status verified date

Apr, 2026

Completion date

Jun, 2028

Anticipated

Primary completion date

Jun, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 3 - 21

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

21 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: L-arginine loading dose + standard dose

L-arginine loading dose (200 mg/kg IV) + standard dose (100 mg/kg IV TID).

active comparator: Standard dose

Standard dose (100mg/kg IV TID).

active comparator: Low dose

Low dose (25mg/kg IV TID).

Interventions

Arginine Hydrochloride

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.

Primary outcome measure

  • Change in mitochondrial function [ Time Frame: Baseline and day 5 ]

Central Contacts and Locations

Central contacts

Claudia R. Morris, MD

404 727-5500claudia.r.morris@emory.edu

Dunia Hatabah, MD

470-6626706dunia.hatabah@emory.edu

Locations

Children's Healthcare of Atlanta (CHOA), Arthur M. Blank

Recruiting

Atlanta, Georgia, United States, 30322

Contacts

Claudia R Morris, MD

404 727-5500claudia.morris@choa.org

Principal Investigator:

Caludia R Morris, MD

More Information

Sponsor

Emory University

Last update posted

Apr 15, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Emory University on 2026-04-15.