NCT05855330 Arginine Replacement Therapy in COVID-19
| NCT ID | NCT05855330 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Emory University |
| Condition | COVID-19 |
| Study Type | INTERVENTIONAL |
| Enrollment | 21 participants |
| Start Date | 2024-01-08 |
| Primary Completion | 2028-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 21 participants in total. It began in 2024-01-08 with a primary completion date of 2028-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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 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
Contact & Investigator
Claudia R. Morris, MD
PRINCIPAL INVESTIGATOR
Emory University
Frequently Asked Questions
Who can join the NCT05855330 clinical trial?
This trial is open to participants of all sexes, aged 3 Years or older, up to 21 Years, studying COVID-19. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05855330 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05855330 currently recruiting?
Yes, NCT05855330 is actively recruiting participants. Contact the research team at claudia.r.morris@emory.edu for enrollment information.
Where is the NCT05855330 trial being conducted?
This trial is being conducted at Atlanta, United States.
Who is sponsoring the NCT05855330 clinical trial?
NCT05855330 is sponsored by Emory University. The principal investigator is Claudia R. Morris, MD at Emory University. The trial plans to enroll 21 participants.
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