Arginine Replacement Therapy in COVID-19 — ART-COVID19  

COVID-19 Clinical Trial

Official title: Prospective Open-Label Pilot Study of Arginine Replacement Therapy in Children Hospitalized With COVID-19

Status Recruiting

Clinical Trial Summary

The purpose of this study is 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 in Children's Healthcare of Atlanta, Egleston campus. 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.

Clinical Trial Description

In the early stages of COVID-19, it was believed that children were immune or had very mild disease. Given the unfolding pandemic, children's cases are exhibiting an increasing global trend and are associated with some serious complications in addition to more long-term complications such as multisystem inflammatory syndrome in children (MIS-C) and "Long Covid". A significant number of hospitalized and critically ill pediatric patients have now been documented, in addition to a high number of emergency department (ED) visits despite previous reports suggesting rare or mild disease in children. The research team and others have shown that severe COVID-19 and MIS-C are associated with acute arginine deficiency in both adults and children. There has been increased evidence of the role of the endothelium associated with severe inflammation in COVID-19. Low plasma arginine bioavailability has been implicated in endothelial dysfunction, immune regulation, and hypercoagulation. The research team also identified high sPLA2 levels in COVID-19 and MIS-C, an observation previously made in children with Kawasaki's Disease. Subsequent studies have shown that sPLA2 is associated with the pathobiology leading to COVID-19 mortality, with enzyme levels 10-fold higher in people who died vs. mild disease, and is also associated with Mito dysfunction. Not only could sPLA2 represent a prognostic indicator of disease severity, but it also represents a mechanism with potential therapeutic targets.

Information learned from the Mito activity in COVID-19 can contribute to further understanding of severe acute respiratory syndrome by coronavirus (SARS-CoV-2) infection. This data may help guide future treatment targets and strategies. ;

Related Conditions & MeSH terms

• COVID-19

• NCT number: NCT05855330
• Study type: Interventional
• Source: Emory University
• Contact: Claudia R. Morris, MD
• Phone: 404 727-5500
• Email: claudia.r.morris@emory.edu
• Status: Recruiting
• Phase: Phase 2
• Start date: January 8, 2024
• Completion date: June 2025