Arginine therapy for children with COVID-19

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the effects of arginine replacement therapy on mitochondrial function in children hospitalized with COVID-19. Participants aged 3 to 21 will be randomized to receive one of three doses of arginine three times daily for five days or until discharge. The research aims to address the observed acute arginine deficiency linked to severe COVID-19 and its complications, including multisystem inflammatory syndrome in children (MIS-C). By exploring the potential therapeutic benefits of arginine, the study seeks to improve patient outcomes in this vulnerable population.

Why it matters

Who can join: the full rules

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

Where it's running

• Children's Healthcare of Atlanta (CHOA), Arthur M. Blank
  Atlanta, Georgia, United States Recruiting

Study contacts

• Principal investigator: Claudia R. Morris, MD — Emory University
• Study coordinator: Claudia R. Morris, MD
• Email: claudia.r.morris@emory.edu
• Phone: 404 727-5500

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Comparative Immunogenicity of Respiratory Virus Vaccines (CIRV2) in Adults

  This study tests and compares the immune responses and tolerability of the latest COVID-19 vaccines from Novavax and Pfizer/BioNTech in adults at risk for severe COVID-19.

  Recruiting Phase 4 Henry M. Jackson Foundation for the Advancement of Military Medicine · Bethesda, Maryland · NCT07287137

• Omicron-based COVID-19 vaccine with Matrix-M given as a single dose in older adults and high-risk individuals

  A single-dose Omicron-subvariant vaccine with Matrix-M is tested to see if it is safe and can induce an immune response in adults 65+ and in younger adults with conditions that raise the risk of severe COVID-19, who were previously vaccinated.

  Recruiting at 20 sites Phase 4 Sanofi · Fair Oaks, California and 19 other locations · NCT07861542

• Secutrelvir for nonhospitalized COVID-19 in teens and adults

  This study tests whether secutrelvir can help nonhospitalized people with COVID-19 see faster symptom relief compared with a placebo.

  Recruiting Phase 3 Shionogi Inc. · Multiple Locations · NCT07746544

• Virological Monitoring of Seasonal Respiratory Infections in France

  This project tests how often common respiratory viruses show up in patients seen by primary care doctors in metropolitan France during the fall and winter.

  Recruiting Institut National de la Santé Et de la Recherche Médicale, France · Paris · NCT07599449

• COVID-19 Registry at San Matteo (SMACORE) - patient-matching observational registry

  This registry tests how COVID-19 patients are being treated and progress across San Matteo in Pavia to understand patterns and outcomes.

  Recruiting Fondazione IRCCS Policlinico San Matteo di Pavia · Pavia · NCT07597876

• MDX2301 in healthy adults and adults at higher risk for severe COVID-19

  This study will try single and repeat doses of MDX2301 given by IV, IM, or SC to see if they are safe and trigger neutralizing activity in healthy adults and adults at higher risk for severe COVID-19.

  Recruiting at 2 sites Phase 1 ModeX Therapeutics, An OPKO Health Company · Las Vegas, Nevada and 1 other locations · NCT07445971

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.