Arginine therapy for children with COVID-19
Prospective Open-Label Pilot Study of Arginine Replacement Therapy in Children Hospitalized With COVID-19
This study is testing if giving arginine to children hospitalized with COVID-19 can help improve their health and recovery.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 21 (estimated) |
| Ages | 3 Years to 21 Years |
| Sex | All |
| Sponsor | Emory University Academic / other |
| Locations | 1 site (Atlanta, Georgia) |
| Trial ID | NCT05855330 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are children aged 3 to 21 years who have been diagnosed with COVID-19 and require hospitalization.
Not a fit: Patients with severe hepatic or renal dysfunction, significant pulmonary disease, or a history of severe neurocognitive delays may not benefit from this study.
Why it matters
Potential benefit: If successful, this therapy could enhance mitochondrial function and reduce complications associated with COVID-19 in children.
How similar studies have performed: While the approach of arginine therapy in COVID-19 is novel, previous studies have indicated a link between arginine deficiency and severe outcomes in COVID-19, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion 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 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 this trial is running
Atlanta, Georgia
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.